Podcasts about Sanofi

This episode covers: Cardiology This Week: A concise summary of recent studies ICD Indications in primary prevention Drug treatment of cardiac amyloidosis Mythbusters Host: Rick Grobbee Guests: Carlos Aguiar, Gerhard Hindricks, Marianna Fontana Want to watch that episode? Go to: https://esc365.escardio.org/event/1810   Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors.  This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails. Declarations of interests: Stephan Achenbach, Rick Grobbee, Gerhard Hindricks and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Marianna Fontana has declared to have potential conflicts of interest to report: consultancy for Alnylam, Alexion/Caelum Biosciences, Astrazeneca, Bridgbio/Eidos, Prothena, Attralus, Intellia Therapeutics, Ionis Pharmaceuticals, Cardior, Lexeo Therapeutics, Janssen Pharmaceuticals, Prothena, Pfizer, Novonordisk, Bayer, Mycardium. Research grants from: Alnylam, Bridgbio, Astrazeneca, Pfizer. Share options in LexeoTherapeutics and shares in Mycardium. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Rick Grobbee Guest: Gerhard Hindricks Want to watch that extended interview? Go to: https://esc365.escardio.org/event/1810?r Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails. Declarations of interests: Stephan Achenbach, Rick Grobbee, Gerhard Hindricks and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Johnson & Johnson reported second-quarter earnings of $23.7 billion, driven by cancer and neuroscience drugs, exceeding analyst expectations. CEO Joaquin Duato set a target of $50 billion in oncology sales by 2030. Despite challenges in the industry, Johnson & Johnson remains optimistic about its oncology sales target as the biotech industry continues to navigate the evolving landscape of drug development and funding.In a difficult investing environment where IPOs are not guaranteed, AI-focused biotech unicorns are facing challenges in securing funding. GSK's Blenrep is facing setbacks as the FDA questions its efficacy in treating multiple myeloma, while AstraZeneca's amyloidosis asset failed to improve survival in a late-stage trial. The industry is also seeing the rise of women leaders like Audrey Greenberg and the team at Acadia, who are making significant contributions to the field.Biospace is launching a new weekly newsletter focused on critical manufacturing issues in the biopharma industry, covering developments and impacts on companies such as Roche, Sanofi, and Johnson & Johnson. The newsletter aims to provide deep dives, analysis, and roundups of the biggest manufacturing stories of the week every Tuesday. Stay informed with weekly analysis and updates on the changing landscape of manufacturing in the U.S.

What does it truly mean to lead when the world around you crumbles and rebuilds itself?This episode features host Denis Gianoutsos' most powerful conversations with two extraordinary leaders. Dr. Nadya Zhexembayeva, born to political dissidents in Soviet Kazakhstan, witnessed her world collapse overnight—yet discovered that leadership is a dynamic space we enter and exit, not a fixed title. Ken Miller, a healthcare executive with 32 years of global experience, reveals the athletic mindset required for modern leadership and why our most outstanding teachers are found in our closest relationships, not boardrooms.Join Denis Gianoutsos for this transformative mashup—your perspective on leadership may never be the same.EP 221 - Dr. Nadya Zhexembayeva: Leadership as a Dynamic Space: From Soviet Collapse to Revolutionary ThinkingBorn in Soviet Kazakhstan to political dissidents, witnessed sudden USSR collapse, creating a complete vacuumRedefines leadership as a space you enter and exit daily, not a fixed title or position.Draws from Kazakh nomadic culture,e viewing leadership as a dynamic circle larger than any individualIdentifies daughter and parents as most significant leadership influences, emphasizing self-love before leading othersEP 225 - Ken Miller: Healthcare Leadership and the Athletic Mindset: Building Legacy Through Purpose32 years in healthcare at companies like Sanofi, Pfizer, Roche, choosing impact over just profitDescribes leaders as athletes - highly competitive with a tireless appetite for success and sacrificeEmphasizes continuous learning and personal development rather than relying on organizationsCites Dr. Martin Luther King Jr. as a favorite leader for authenticity and fighting for something bigger than himselfKey Quotes:"Leadership for me is a space. You enter and exit many times a day." - Dr. Nadya Zhexembayeva"You've gotta have a work ethic, which is second to none, to really have an impact around the world." - Ken MillerThe 10 Proven Ways to Lead and Thrive in Today's World - FREE Executive Guide Download https://crm.leadingchangepartners.com/10-ways-to-lead Connect with Denis:Email: denis@leadingchangepartners.comWebsite: www.LeadingChangePartners.com Facebook: https://www.facebook.com/denisgianoutsos LinkedIn: https://www.linkedin.com/in/denisgianoutsos/ Instagram: https://www.instagram.com/leadershipischanging/ YouTube Channel: https://www.youtube.com/@DenisGianoutsos

What is the environmental impact of respiratory illness? Find out in this episode of the EMJ GOLD podcast, where Shish Patel, Medical Director, Chiesi UK, joins Isabel to discuss the rising burden of COPD and the impact of respiratory care on the planet.  Together, the two explore the diagnostic gap in COPD, improving the experience of people living with the disease, balancing health innovation with climate concerns and much more.   A little more on EMJ GOLD's guest…  Shish Patel trained as a pharmacist and has worked in the pharmaceutical industry for over 30 years. Currently, he serves as Medical Director at Chiesi UK and Ireland, and he has held senior positions within medical and scientific functions at both affiliate and global level throughout his career. In addition to his significant time at Chiesi, Shish has held positions at GSK and Sanofi. Shish also holds key industry board positions including at the Prescription Medicines Code of Practice Authority and the ABPI.   

Drs. Hope Rugo, Sheri Brenner, and Mikolaj Slawkowski-Rode discuss the struggle that health care professionals experience when terminally ill patients are suffering and approaches to help clinicians understand and respond to suffering in a more patient-centered and therapeutic way. TRANSCRIPT Dr. Hope Rugo: Hello, and welcome to By the Book, a monthly podcast series from ASCO that features engaging conversations between editors and authors of the ASCO Educational Book.  I'm your host, Dr. Hope Rugo. I'm director of the Women's Cancers Program and division chief of breast medical oncology at the City of Hope Cancer Center, and I'm also the editor-in-chief of the Educational Book. On today's episode, we'll be exploring the complexities of grief and oncology and the struggle we experience as healthcare professionals when terminally ill patients are suffering. Our guests will discuss approaches to help clinicians understand and respond to suffering in a more patient-centered and therapeutic way, as outlined in their recently published article titled, “Oncology and Suffering: Strategies on Coping With Grief for Healthcare Professionals.” I'm delighted today to welcome Dr. Keri Brenner, a clinical associate professor of medicine, palliative care attending, and psychiatrist at Stanford University, and Dr. Mikołaj Sławkowski-Rode, a senior research fellow in philosophy in the Humanities Research Institute at the University of Buckingham, where he also serves as director of graduate research in p hilosophy. He is also a research fellow in philosophy at Blackfriars Hall at the University of Oxford and associate professor at the University of Warsaw.  Our full disclosures are available in the transcript of this episode. Dr. Brenner and Dr. Sławkowski-Rode, thanks for being on the podcast today. Dr. Keri Brenner: Great to be here, Dr. Rugo. Thank you so much for that kind introduction. Dr. Mikołaj Sławkowski-Rode: Thank you very much, Dr. Rugo. It's a pleasure and an honor. Dr. Hope Rugo: So I'm going to start with some questions for both of you. I'll start with Dr. Brenner. You've spoken and written about the concept of suffering when there is no cure. For oncologists, what does it mean to attune to suffering, not just disease? And how might this impact the way they show up in difficult conversations with patients? Dr. Keri Brenner: Suffering is something that's so omnipresent in the work of clinical oncology, and I like to begin by just thinking about what is suffering, because it's a word that we use so commonly, and yet, it's important to know what we're talking about. I think about the definition of Eric Cassell, who was a beloved mentor of mine for decades, and he defined suffering as the state of severe distress that's associated with events that threaten the intactness of a person. And my colleague here at Stanford, Tyler Tate, has been working on a definition of suffering that encompasses the experience of a gap between how things are versus how things ought to be. Both of these definitions really touch upon suffering in a person-centered way that's relational about one's identity, meaning, autonomy, and connectedness with others. So these definitions alone remind us that suffering calls for a person-centered response, not the patient as a pathology, but the panoramic view of who the patient is as a person and their lived reality of illness. And in this light, the therapeutic alliance becomes one of our most active ingredients in care. The therapeutic alliance is that collaborative, trusting bond as persons that we have between clinician and patient, and it's actually one of the most powerful predictors of meaningful outcomes in our care, especially in oncologic care.  You know, I'll never forget my first day of internship at Massachusetts General Hospital. A faculty lecturer shared this really sage insight with us that left this indelible mark. She shared, “As physicians and healers, your very self is the primary instrument of healing. Our being is the median of the medicine.” So, our very selves as embodied, relationally grounded people, that's the median of the medicine and the first most enduring medicine that we offer. That has really borne fruit in the evidence that we see around the therapeutic alliance. And we see this in oncologic care, that in advanced cancer, a strong alliance with one's oncologist truly improves a patient's quality of life, treatment adherence, emotional well-being, and even surpasses structured interventions like psychotherapeutic interventions. Dr. Hope Rugo: That's just incredibly helpful information and actually terminology as well, and I think the concept of suffering differs so much. Suffering comes in many shapes and forms, and I think you really have highlighted that. But many oncologists struggle with knowing what to do when patients are suffering but can't be fixed, and I think a lot of times that has to do with oncologists when patients have pain or shortness of breath or issues like that. There are obviously many ways people suffer. But I think what's really challenging is how clinicians understand suffering and what the best approaches to respond to suffering are in the best patient-centered and therapeutic way. Dr. Keri Brenner: I get that question a lot from my trainees in palliative care, not knowing what to do. And my first response is, this is about how to be, not about knowing what to do, but how to be. In our medical training, we're trained often how to think and treat, but rarely how to be, how to accompany others. And I often have this image that I tell my trainees of, instead of this hierarchical approach of a fix-it mentality of all we're going to do, when it comes to elements of unavoidable loss, mortality, unavoidable sufferings, I imagine something more like accompaniment, a patient walking through some dark caverns, and I am accompanying them, trying to walk beside them, shining a light as a guide throughout that darkness. So it's a spirit of being and walking with. And it's so tempting in medicine to either avoid the suffering altogether or potentially overidentify with it, where the suffering just becomes so all-consuming like it's our own. And we're taught to instead strike a balance of authentic accompaniment through it. I often teach this key concept in my palli-psych work with my team about formulation. Formulation is a working hypothesis. It's taking a step back and asking, “Why? Why is this patient behaving in this manner? What might the patient's core inner struggle be?” Because asking that “why” and understanding the nuanced dimensions of a patient's core inner struggle will really help guide our therapeutic interactions and guide the way that we accompany them and where we choose to shine that light as we're walking with them. And oftentimes people think, “Well Keri, that sounds so sappy or oversentimental,” and it's not. You know, I'm just thinking about a case that I had a couple months ago, and it was a 28-year-old man with gastric cancer, metastatic disease, and that 28-year-old man, he was actually a college Division I athlete, and his dad was an acclaimed Division I coach. And our typical open-ended palliative care questions, that approach, infuriated them. They needed to know that I was showing up confident, competent, and that I was ready, on my A-game, with a real plan for them to follow through. And so my formulation about them was they needed somebody to show up with that confidence and competence, like the Division I athletes that they were, to really meet them and accompany them where they were on how they were going to walk through that experience of illness. Dr. Hope Rugo: These kinds of insights are so helpful to think about how we manage something that we face every day in oncology care. And I think that there are many ways to manage this.  Maybe I'll ask Dr. Sławkowski-Rode one question just that I think sequences nicely with what you're talking about.  A lot of our patients are trying to think about sort of the bigger picture and how that might help clinicians understand and support patients. So, the whole concept of spirituality, you know, how can we really use that as oncology clinicians to better understand and support patients with advanced illness, and how can that help patients themselves? And we'll talk about that in two different ways, but we'll just start with this broader question. Dr. Mikołaj Sławkowski-Rode: I think spirituality, and here, I usually refer to spirituality in terms of religious belief. Most people in the world are religious believers, and it is very intuitive and natural that religious beliefs would be a resource that people who help patients with a terminal diagnosis and healthcare professionals who work with those patients appeal to when they try to help them deal with the trauma and the stress of these situations.  Now, I think that the interesting thing there is that very often the benefit of appealing to a religious belief is misunderstood in terms of what it delivers. And there are many, many studies on how religious belief can be used to support therapy and to support patients in getting through the experience of suffering and defeating cancer or facing a terminal diagnosis. There's a wealth of literature on this. But most of the literature focuses on this idea that by appealing to religious belief, we help patients and healthcare practitioners who are working with them get over the fact and that there's a terminal diagnosis determining the course of someone's life and get on with our lives and engaging with whatever other pursuits we might have, with our job if we're healthcare practitioners, and with the other things that we might be passionate about in our lives. And the idea here is that this is what religion allows us to do because we sort of defer the need to worry about what's going to happen to us until the afterlife or some perspective beyond the horizon of our life here.  However, my view is – I have worked beyond philosophy also with theologians from many traditions, and my view here is that religion is something that does allow us to get on with our life but not because we're able to move on or move past the concerns that are being threatened by illness or death, but by forming stronger bonds with these things that we value in our life in a way and to have a sense of hope that these will be things that we will be able to keep an attachment to despite the threat to our life. So, in a sense, I think very many approaches in the field have the benefit of religion upside down, as it were, when it comes to helping patients and healthcare professionals who are engaged with their illness and treating it. Dr. Hope Rugo: You know, it's really interesting the points that you make, and I think really important, but, you know, sometimes the oncologists are really struggling with their own emotional reactions, how they are reacting to patients, and dealing with sort of taking on the burden, which, Dr. Brenner, you were mentioning earlier. How can oncologists be aware of their own emotional reactions? You know, they're struggling with this patient who they're very attached to who's dying or whatever the situation is, but you want to avoid burnout as an oncologist but also understand the patient's inner world and support them. Dr. Keri Brenner: I believe that these affective, emotional states, they're contagious. As we accompany patients through these tragic losses, it's very normal and expected that we ourselves will experience that full range of the human experience as we accompany the patients. And so the more that we can recognize that this is a normative dimension of our work, to have a nonjudgmental stance about the whole panoramic set of emotions that we'll experience as we accompany patients with curiosity and openness about that, the more sustainable the work will become. And I often think about the concept of countertransference given to us by Sigmund Freud over 100 years ago. Countertransference is the clinician's response to the patient, the thoughts, feelings, associations that come up within us, shaped by our own history, our own life events, those unconscious processes that come to the foreground as we are accompanying patients with illness. And that is a natural part of the human experience. Historically, countertransference was viewed as something negative, and now it's actually seen as a key that can unlock and enlighten the formulation about what might be going on within the patient themselves even. You know, I was with a patient a couple weeks ago, and I found myself feeling pretty helpless and hopeless in the encounter as I was trying to care for them. And I recognized that countertransference within myself that I was feeling demoralized. It was a prompt for me to take a step back, get on the balcony, and be curious about that because I normally don't feel helpless and hopeless caring for my patients. Well, ultimately, I discovered through processing it with my interdisciplinary team that the patient likely had demoralization as a clinical syndrome, and so it's natural many of us were feeling helpless and hopeless also accompanying them with their care. And it allowed us to have a greater interdisciplinary approach and a more therapeutic response and deeper empathy for the patient's plight. And we can really be curious about our countertransferences. You know, a few months ago, I was feeling bored and distracted in a family meeting, which is quite atypical for me when I'm sharing serious illness news. And it was actually a key that allowed me to recognize that the patient was trying to distract all of us talking about inconsequential facts and details rather than the gravitas of her illness.  Being curious about these affective states really allows us to have greater sustainability within our own practice because it normalizes that human spectrum of emotions and also allows us to reduce unconscious bias and have greater inclusivity with our practice because what Freud also said is that what we can't recognize and say within our own selves, if we don't have that self-reflective capacity, it will come out in what we do. So really recognizing and having the self-awareness and naming some of these emotions with trusted colleagues or even within our own selves allows us to ensure that it doesn't come out in aberrant behaviors like avoiding the patient, staving off that patient till the end of the day, or overtreating, offering more chemotherapy or not having the goals of care, doing everything possible when we know that that might result in medically ineffective care. Dr. Hope Rugo: Yeah, I love the comments that you made, sort of weaving in Freud, but also, I think the importance of talking to colleagues and to sharing some of these issues because I do think that oncologists suffer from the fact that no one else in your life wants to hear about dying people. They don't really want to hear about the tragic cases either. So, I think that using your community, your oncology community and greater community within medicine, is an important part of being able to sort of process. Dr. Keri Brenner: Yes, and Dr. Rugo, this came up in our ASCO [Education] Session. I'd love to double click into some of those ways that we can do this that aren't too time consuming in our everyday practice. You know, within palliative care, we have interdisciplinary rounds where we process complex cases. Some of us do case supervision with a trusted mentor or colleague where we bring complex cases to them. My team and I offer process rounds virtually where we go through countertransference, formulation, and therapeutic responses on some tough cases.  You know, on a personal note, just last week when I left a family meeting feeling really depleted and stuck, I called one of my trusted colleagues and just for 3 minutes constructively, sort of cathartically vented what was coming up within me after that family meeting, which allowed me to have more of an enlightened stance on what to do next and how to be therapeutically helpful for the case. One of my colleagues calls this "friend-tors." They coined the phrase, and they actually wrote a paper about it. Who within your peer group of trusted colleagues can you utilize and phone in real time or have process opportunities with to get a pulse check on where what's coming up within us as we're doing this work? Dr. Hope Rugo: Yeah, and it's an interesting question about how one does that and, you know, maintaining that as you move institutions or change places or become more senior, it's really important.  One of the, I think, the challenges sometimes is that we come from different places from our patients, and that can be an issue, I think when our patients are very religious and the provider is not, or the reverse, patients who don't have religious beliefs and you're trying to sort of focus on the spirituality, but it doesn't really ring true. So, Dr. Sławkowski-Rode, what resources can patients and practitioners draw on when they're facing death and loss in the absence of, or just different religious beliefs that don't fit into the standard model? Dr. Mikołaj Sławkowski-Rode: You're absolutely right that this can be an extremely problematic situation to be in when there is that disconnect of religious belief or more generally spiritual engagement with the situation that we're in. But I just wanted to tie into what Dr. Brenner was saying just before. I couldn't agree more, and I think that a lot of healthcare practitioners, oncologists in particular who I've had the pleasure to talk to at ASCO and at other events as well, are very often quite skeptical about emotional engagement in their profession. They feel as though this is something to be managed, as it were, and something that gets in the way. And they can often be very critical of methods that help them understand the emotions and extend them towards patients because they feel that this will be an obstacle to doing their job and potentially an obstacle also to helping patients to their full ability if they focus on their own emotions or the burden that emotionally, spiritually, and in other ways the illness is for the patient. They feel that they should be focusing on the cancer rather than on the patient's emotions. And I think that a useful comparison, although, you know, perhaps slightly drastic, is that of combat experience of soldiers. They also need to be up and running and can't be too emotionally invested in the situation that they're in. But there's a crucial difference, which is that soldiers are usually engaged in very short bursts of activity with the time to go back and rethink, and they often have a lot of support for this in between. Whereas doctors are in a profession where their exposure to the emotions of patients and their own emotions, the emotions of families of patients is constant. And I think that there's a great danger in thinking that this is something to be avoided and something to compartmentalize in order to avoid burnout. I think, in a way, burnout is more sure to happen if your emotions and your attachment to your patients goes ignored for too long. So that's just following up on Keri's absolutely excellent points. As far as the disconnect is concerned, that's, in fact, an area in which I'm particularly interested in. That's where my research comes in. I'm interested in the kinds of connections that we have with other people, especially in terms of maintaining bonds when there is no spiritual belief, no spiritual backdrop to support this connection. In most religious traditions, we have the framework of the religious belief that tells us that the person who we've lost or the values that have become undermined in our life are something that hasn't been destroyed permanently but something that we can still believe we have a deep connection to despite its absence from our life. And how do you rebuild that sense of the existence of the things that you have perceivably lost without the appeal to some sort of transcendent realm which is defined by a given religion? And that is a hard question. That's a question, I think, that can be answered partly by psychology but also partly by philosophy in terms of looking at who we are as human beings and our nature as people who are essentially, or as entities that are essentially connected to one another. That connection, I believe, is more direct than the mediation of religion might at first suggest. I think that we essentially share the world not only physically, it's not just the case that we're all here, but more importantly, the world that we live in is not just the physical world but the world of meanings and values that helps us orient ourselves in society and amongst one another as friends and foes. And it is that shared sense of the world that we can appeal to when we're thinking about retaining the value or retaining the connection with the people who we have lost or the people who are helping through, go through an experience of facing death. And just to finish, there's a very interesting question, I think, something that we possibly don't have time to explore, about the degree of connection that we have with other people. So, what I've just been saying is something that rings more true or is more intuitive when we think about the connections that we have to our closest ones. We share a similar outlook onto the world, and our preferences and our moods and our emotions and our values are shaped by life with the other person. And so, appealing to these values can give us a sense of a continued presence. But what in those relationships where the connection isn't that close? For example, given the topic of this podcast, the connection that a patient has with their doctor and vice versa. In what sense can we talk about a shared world of experience? Well, I think, obviously, we should admit degrees to the kind of relationship that can sustain our connection with another person. But at the same time, I don't think there's a clear cutoff point. And I think part of emotional engagement in medical practice is finding yourself somewhere on that spectrum rather than thinking you're completely off of it. That's what I would say. Dr. Hope Rugo: That's very helpful and I think a very helpful way of thinking about how to manage this challenging situation for all of us.  One of the things that really, I think, is a big question for all of us throughout our careers, is when to address the dying process and how to do that. Dr. Brenner, you know, I still struggle with this – what to do when patients refuse to discuss end-of-life but they're very close to end of life? They don't want to talk about it. It's very stressful for all of us, even where you're going to be, how you're going to manage this. They're just absolutely opposed to that discussion. How should we approach those kinds of discussions? How do we manage that? How do you address the code discussion, which is so important? You know, these patients are not able to stay at home at end-of-life in general, so you really do need to have a code discussion before you're admitting them. It actually ends up being kind of a challenge and a mess all around. You know, I would love your advice about how to manage those situations. Dr. Keri Brenner: I think that's one of the most piercing and relevant inquiries we have within our clinical work and challenges. I often think of denial not as an all-or-nothing concept but rather as parts of self. There's a part of everyone's being where the unconscious believes it's immortal and will live on forever, and yet we all know intellectually that we all have mortality and finitude and transience, and that time will end. We often think of this work as more iterative and gradual and exposure based. There's potency to words. Saying, “You are dying within days,” is a lot higher potency of a phrase to share than, “This is serious illness. This illness is incurable. Time might be shorter than we hoped.” And so the earlier and more upstream we begin to have these conversations, even in small, subtle ways, it starts to begin to expose the patient to the concept so they can go from the head to the heart, not only knowing their prognosis intellectually but also affectively, to integrate it into who they are as a person because all patients are trying to live well while also we're gradually exposing them to this awareness of mortality within their own lived experience of illness. And that, ideally, happens gradually over time. Now, there are moments where the medical frame is very limited, and we might have short days, and we have to uptitrate those words and really accompany them more radically through those high-affective moments. And that's when we have to take a lot of more nuanced approaches, but I would say the more earlier and upstream the better. And then the second piece to that question as well is coping with our own mortality. The more we can be comfortable with our own transience and finitude and limitations, the more we will be able to accompany others through that. And even within my own life, I've had to integrate losses in a way where before I go in to talk to one of my own palliative care patients, one mantra I often say to myself is, “I'm just a few steps behind you. I don't know if it's going to be 30 days or 30 years, but I'm just a few steps behind you on this finite, transient road of life that is the human experience.” And that creates a stance of accompaniment that patients really can experience as they're traversing these tragedies. Dr. Hope Rugo: That's great. And I think those are really important points and actually some pearls, which I think we can take into the clinic. I think being really concrete when really the expected life expectancy is a few days to a couple of weeks can be very, very helpful. And making sure the patients hear you, but also continuing to let them know that, as oncologists, we're here for them. We're not abandoning them. I think that's a big worry for many, certainly of my patients, is that somehow when they would go to hospice or be a ‘no code', that we're not going to support them anymore or treat them anymore. That is a really important process of that as well. And of course, engaging the team makes a big difference because the whole oncology team can help to manage situations that are particularly challenging like that. And just as we close, I wanted to ask one last question of you, Dr. Brenner, that suffering, grief, and burnout, you've really made the point that these are not problems to fix but dimensions that we want to attend to and acknowledge as part of our lives, the dying process is part of all of our lives. It's just dealing with this in the unexpected and the, I think, unpredictability of life, you know, that people take on a lot of guilt and all sorts of things about, all sorts of emotions. And the question is now, people have listened to this podcast, what can they take back to their oncology teams to build a culture that supports clinicians and their team at large to engage with these realities in a meaningful and sustainable way? I really feel like if we could build the whole team approach where we're supporting each other and supporting the patients together, that that will help this process immeasurably. Dr. Keri Brenner: Yes, and I'm thinking about Dr. Sławkowski-Rode's observation about the combat analogy, and it made me recognize this distinction between suppression and repression. Repression is this unconscious process, and this is what we're taught to do in medical training all the time, to just involuntarily shove that tragedy under the rug, just forget about it and see the next patient and move on. And we know that if we keep unconsciously shoving things under the rug, that it will lead to burnout and lack of sustainability for our clinical teams. Suppression is a more conscious process. That deliberate effort to say, “This was a tragedy that I bore witness to. I know I need to put that in a box on the shelf for now because I have 10 other patients I have to see.” And yet, do I work in a culture where I can take that off the shelf during particular moments and process it with my interdisciplinary team, phone a friend, talk to a trusted colleague, have some trusted case supervision around it, or process rounds around it, talk to my social worker? And I think the more that we model this type of self-reflective capacity as attendings, folks who have been in the field for decades, the more we create that ethos and culture that is sustainable because clinician self-reflection is never a weakness, rather it's a silent strength. Clinician self-reflection is this portal for wisdom, connectedness, sustainability, and ultimately transformative growth within ourselves. Dr. Hope Rugo: That's such a great point, and I think this whole discussion has been so helpful for me and I hope for our audience that we really can take these points and bring them to our practice. I think, “Wow, this is such a great conversation. I'd like to have the team as a whole listen to this as ways to sort of strategize talking about the process, our patients, and being supportive as a team, understanding how we manage spirituality when it connects and when it doesn't.” All of these points, they're bringing in how we process these issues and the whole idea of suppressing versus sort of deciding that it never happened at all is, I think, very important because that's just a tool for managing our daily lives, our busy clinics, and everything we manage. Dr. Keri Brenner: And Dr. Rugo, it's reminding me at Stanford, you know, we have this weekly practice that's just a ritual where every Friday morning for 30 minutes, our social worker leads a process rounds with us as a team, where we talk about how the work that we're doing clinically is affecting us in our lives in ways that have joy and greater meaning and connectedness and other ways that might be depleting. And that kind of authentic vulnerability with one another allows us to show up more authentically for our patients. So those rituals, that small 30 minutes once a week, goes a long way. And it reminds me that sometimes slowing things down with those rituals can really get us to more meaningful, transformative places ultimately. Dr. Hope Rugo: It's a great idea, and I think, you know, making time for that in everybody's busy days where they just don't have any time anymore is important. And you don't have to do it weekly, you could even do something monthly. I think there's a lot of options, and that's a great suggestion. I want to thank you both for taking your time out for this enriching and incredibly helpful conversation. Our listeners will find a link to the Ed Book article we discussed today, which is excellent, in the transcript of this episode. I want to thank you again, Dr. Brenner and Dr. Sławkowski-Rode, for your time and for your excellent thoughts and advice and direction. Dr. Mikołaj Sławkowski-Rode: Thank you very much, Dr. Rugo. Dr. Keri Brenner: Thank you. Dr. Hope Rugo: And thanks to our listeners for joining us today. Please join us again next month on By the Book for more insightful views on topics you'll be hearing at the education sessions from ASCO meetings and our deep dives on new approaches that are shaping modern oncology. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:      Dr. Hope Rugo @hope.rugo Dr. Keri Brenner @keri_brenner Dr. Mikolaj Slawkowski-Rode @MikolajRode Follow ASCO on social media:      @ASCO on X (formerly Twitter)      ASCO on Bluesky     ASCO on Facebook      ASCO on LinkedIn      Disclosures:     Dr. Hope Rugo: Honoraria: Mylan/Viatris, Chugai Pharma Consulting/Advisory Role: Napo Pharmaceuticals, Sanofi, Bristol Myer Research Funding (Inst.): OBI Pharma, Pfizer, Novartis, Lilly, Merck, Daiichi Sankyo, AstraZeneca, Gilead Sciences, Hoffman La-Roche AG/Genentech, In., Stemline Therapeutics, Ambryx Dr. Keri Brenner: No relationships to disclose Dr. Mikolaj Slawkowski-Rode: No relationships to disclose    

We dive into the world of cutting-edge cancer treatments with Aino Kalervo, Chief Operating Officer of TILT Biotherapeutics and occasional tennis legend in her spare time.TILT recently closed a $25M series B round, backed by leading Finnish investors, to finance the clinical development of its oncolytic virus candidate to supercharge cancer immunotherapies.We also explore the challenging space of oncolytic viruses and the untapped potential of biotech innovation in Finland.______For transparency, this episode has been sponsored by TILT.______⭐️ ABOUT THE SPEAKERAino Kalervo is the Chief Operating Officer of TILT Biotherapeutics, responsible for fundraising and business development. She has also served as the president of TILT's US affiliate since 2022. Prior to joining TILT, she worked for Sanofi and the French therapeutic vaccine company Theravectys.

Screening has moved front and center in the conversation around type 1 diabetes. But we're just at the very beginning of this – what do we really need to know? I'm talking to Dr. Shara Bialo – she's a pediatric endocrinologist who lives with type 1. She was diagnosed as a kid while in DKA. She's working with Sanofi to push for screening, but this is personal – we talk about wanting better guidelines, and more mental health support. And how do we move this research into the general population, where it can have the greatest impact? More about screening here  This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Previous episodes with Ben Mar here Join us at an upcoming Moms' Night Out event! Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.

In this episode of Patient Advocacy Voices, host Eric Racine and co-host Marco DeThomasis, People Business Partner, Specialty Care at Sanofi, sit down with Schroeder Stribling, President & CEO of Mental Health America (MHA). Together, they explore how data, early intervention, and workplace culture can help address America's growing mental health crisis.From national trends to practical tools, this conversation blends strategy with humanity – offering advocacy and business leaders insights they can apply to help improve mental health in their organizations and communities.Listeners will gain valuable insights on:The importance of screening and tools used by MHA for early identification of mental health concernsWays to reduce stigma and create a culture that promotes trust, authenticity, and wellbeingWhat employees expect and how it leads to a safer and more productive workplaceExamples of how leaders can role model mental wellnessThis episode is a must-listen for anyone ready to rethink ways to advance mental health and wellbeing, whether you're leading an organization, managing a team, serving a community, or advocating for better health policies. Content Warning: This episode includes discussions of sensitive mental health topics. Listener discretion is advised.

What happens when a curious quality assurance tester encounters an odd request about color contrast? For Iulia Brehuescu, it sparked a journey that would transform not only her career but also impact accessibility practices across a global pharmaceutical giant.Iulia's story is both inspiring and cautionary. From her early days testing web platforms at a digital agency to her current role shaping global accessibility strategy at Sanofi, she shares the exhilaration of turning a passion project into meaningful work—and the personal cost when that passion outpaced self-care. "For no surprise to everyone, that came at my physical and mental health expense," she explains of her eventual burnout. Her subsequent recovery and career transition demonstrate how professionals can maintain their impact while establishing healthier boundaries.At Sanofi, Iulia tackles accessibility challenges across physical environments, digital spaces, and organizational culture in 70 countries. She offers fascinating insights into the unique demands of manufacturing sites, where complex layouts require balancing safety with accessibility for approximately 20% of their workforce. The conversation explores how leadership commitment—with half of their executive committee holding inclusion-related roles—creates a culture where accessibility professionals can focus on implementation rather than justification. Yulia's practical approach to balancing strategic vision with day-to-day realities provides valuable lessons for organizations at any stage of their accessibility journey.Ready to transform accessibility from a passion project to a strategic priority in your organization? Listen now and discover how to translate global accessibility frameworks into meaningful local impact while sustaining your own well-being along the way.Support the showFollow axschat on social media.Bluesky:Antonio https://bsky.app/profile/akwyz.com Debra https://bsky.app/profile/debraruh.bsky.social Neil https://bsky.app/profile/neilmilliken.bsky.social axschat https://bsky.app/profile/axschat.bsky.social LinkedInhttps://www.linkedin.com/in/antoniovieirasantos/ https://www.linkedin.com/company/axschat/Vimeohttps://vimeo.com/akwyzhttps://twitter.com/axschathttps://twitter.com/AkwyZhttps://twitter.com/neilmillikenhttps://twitter.com/debraruh

This episode covers: Cardiology This Week: A concise summary of recent studies Big data in cardiology Measuring lipids: what clinicians need to know Milestones Host: Perry Elliott Guests: Carlos Aguiar, Karim Lekadir, Kostas Koskinas Want to watch that episode? Go to: https://esc365.escardio.org/event/1808 Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors.  This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails. Declarations of interests: Stephan Achenbach, Nicolle Kraenkel and Karim Lekadir have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Perry Elliott has declared to have potential conflicts of interest to report: consultancies for Pfizer, BMS, Cytokinetics, AstraZeneca, Forbion. Kostas Koskinas has declared to have potential conflicts of interest to report: speaker fees / honoraria from MSD, Daiichi-Sankyo. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Perry Elliott Guest: Karim Lekadir Want to watch that episode? Go to: https://esc365.escardio.org/event/1808?r Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails. Declarations of interests: Stephan Achenbach, Nicolle Kraenkel and Karim Lekadir have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Perry Elliott has declared to have potential conflicts of interest to report: consultancies for Pfizer, BMS, Cytokinetics, AstraZeneca, Forbion. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson."

Ep.250 Valerie A. Francis is the Founding Director of Knowhere Art Gallery, an independent gallery based on Martha's Vineyard dedicated to showcasing emerging and mid-career artists from diverse backgrounds. The gallery champions inclusive narratives and celebrates the cultural intersections that shape contemporary art today. With a career that bridges global technology innovation and entrepreneurial ventures in the arts, Valerie brings a rare and dynamic blend of strategy, creativity, and cultural insight to every endeavor she leads. Originally trained as an artist, Valerie earned a BFA in Fine Arts from Hunter College CUNY and later an MBA from Rutgers University, specializing in Marketing. Her professional journey took a transformative turn when she entered the world of global healthcare technology at Sanofi, where she rose to serve as a Technology Head leading digital strategy and analytics for teams across North America, Latin America, and Asia. Immersed in a melting pot of cultures and perspectives, she thrived on the diversity and camaraderie forged across continents. Valerie's unwavering commitment to her artistic roots led her to co-found Knowhere Art Gallery in 2019 — a haven where creativity flourishes and artists find their voice. Since its inception, the gallery has achieved remarkable success, becoming a destination for collectors and cultural leaders alike. Under her curatorial direction, Knowhere has presented more than twenty-five exhibitions and introduced the work of over thirty artists. Signature moments include its participation in SCOPE Art Fair (2021–2023) and an acclaimed presentation during the 60th Venice Biennale in 2024 with A Common Thread That Binds Us. As a board member of Artists for Humanity in Boston, Valerie has further committed her passion to action, supporting youth empowerment through creativity and entrepreneurship. She is also dedicated to mentoring artists, cultivating private and corporate art collections, and building institutional collaborations that elevate voices from across the art world. Valerie often describes the founding of Knowhere—conceived on Martha's Vineyard, where she met her partner—as “the nexus of Knowhere,” a place where art, identity, and knowledge converge. Through her work, she continues to sow the seeds of cultural legacy and foster environments where art becomes a catalyst for discovery, connection, and transformation. Website https://knowhereart.com/ 1-54 2025 NYC https://www.1-54.com/new-york/exhibitor-list/knowhere-art-gallery/ artcloud https://artcloud.market/show/knowhere-art-llc-women-rising MV Arts & Ideas https://www.mvartsandideas.com/2024/07/the-road-to-enlightenment-starts-at-knowhere/ Vineyard Gazette https://vineyardgazette.com/news/2024/05/05/knowhere-gallery-showcased-venice-biennale Vineyard Visitor https://vineyardvisitor.com/2024/08/08/art-in-oak-bluffs/knowhere-gallery/ Martha's Vineyard Times https://hype.co/@themarthasvineyardtimes/2z7j289w | https://www.mvtimes.com/2024/06/12/meets-eye-knowhere-art-cousen-rose-galleries/ Martha's Vineyard Arts and Ideas https://www.mvartsandideas.com/2024/07/the-road-to-enlightenment-starts-at-knowhere/ Artsy https://www.artsy.net/partner/knowhere-art

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Beckley's psychedelic nasal spray, BPL-003, has successfully cleared Phase II trials for treatment-resistant depression, showing robust efficacy data. Analysts predict the asset could reach peak market sales of $1 billion. This paves the way for late-stage development and a proposed merger with atai life sciences. In other news, M&A activity saw a significant increase in June, with big pharmas like Eli Lilly, Sanofi, and Novartis making multiple deals. The FDA's decision to remove risk evaluation and mitigation strategies from approved CAR T cancer therapies has been well-received by the cell and gene therapy community. Additionally, Argenx has made a $1.5 billion acquisition of Unum Therapeutics' macrocyclic peptides, aimed at "undruggable" targets. Moderna, Merck, UroGen, and other companies received regulatory nods for various treatments in June. Evotec is hosting a webinar on preserving quality in the pharma industry amidst financial challenges on July 16. Job opportunities in the industry include positions at Biomarin Pharmaceutical Inc., Regeneron Pharmaceuticals, and AbbVie.

For more information regarding this CME/CE activity and to complete the CME/CE requirements and claim credit for this activity, visit:https://www.mycme.com/courses/answers-in-chronic-spontaneous-urticaria-10190SummaryIn this short CE/CME activity, moderator Dr. Brad Glick works with dermatology expert Dr. Gil Yosipovitch to answer your top questions regarding chronic spontaneous urticaria, as gathered from the 2025 NACE Conversations in Dermatology symposium. Questions cover diagnosis, treatment individualization, and more!Learning ObjectivesAt the conclusion of this activity, participants should be better able to:Assess the disease burden and impact on QoL in patients with CSUEvaluate current and emerging therapies for CSUThis activity is accredited for CME/CE CreditThe National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.The National Association for Continuing Education designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.The National Association for Continuing Education is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 121222. This activity is approved for 0.25 contact hours (which includes 0.25 hours of pharmacology).For additional information about the accreditation of this program, please contact NACE at info@naceonline.com.Summary of Individual DisclosuresPlease review faculty and planner disclosures here.Disclosure of Commercial SupportThis activity is supported by an independent educational grant from Sanofi and Regeneron Pharmaceuticals.Please visit http://naceonline.com to engage in more live and on demand CME/CE content.

Dr. Neeraj Agarwal and Dr. Jeanny Aragon-Ching discuss important advances in the treatment of prostate, bladder, and kidney cancers that were presented at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Neeraj Agarwal: Hello, and welcome to the ASCO Daily News Podcast. I am Dr. Neeraj Agarwal, your guest host of the ASCO Daily News Podcast today. I am the director of the Genitourinary Oncology Program and a professor of medicine at the University of Utah Huntsman Cancer Institute and editor-in-chief of the ASCO Daily News.  I am delighted to be joined by Dr. Jeanny Aragon-Ching, a GU medical oncologist and the clinical program director of the GU Center at the Inova Schar Cancer Institute in Virginia. Today, we will be discussing some key abstracts in GU oncology that were presented at the 2025 ASCO Annual Meeting.  Our full disclosures are available in the transcript of this episode.  Jeanny, it is great to have you on the podcast. Dr. Jeanny Aragon-Ching: Oh, thank you so much, Neeraj. Dr. Neeraj Agarwal: Jeanny, let's begin with some prostate cancer abstracts. Let's begin with Abstract 5017 titled, “Phase 1 study results of JNJ-78278343 (pasritamig) in metastatic castration-resistant prostate cancer.” Can you walk us through the design and the key findings of this first-in-human trial? Dr. Jeanny Aragon-Ching: Yeah, absolutely, Neeraj. So this study, presented by Dr. Capucine Baldini, introduces pasritamig, a first-in-class T-cell redirecting bispecific antibody that simultaneously binds KLK2 on prostate cancer cells and CD3 receptor complexes on T cells. KLK2 is also known as human kallikrein 2, which is selectively expressed in prostate tissue. And for reference, KLK3 is what we now know as the PSA, prostate-specific antigen, therefore making it an attractive and specific target for therapeutic engagement. Now, while this was an early, first-in-human, phase 1 study, it enrolled 174 heavily pretreated metastatic CRPC patients. So many were previously treated with ARPIs, taxanes, and radioligand therapy. So given the phase 1 nature of this study, the primary objective was to determine the safety and the RP2D, which is the recommended phase 2 dose. Secondary objectives included preliminary assessment of antitumor activity. So, pasritamig was generally well tolerated. There were no treatment-related deaths. Serious adverse events were rare. And in the RP2D safety cohort, where patients received the step-up dosing up to 300 mg of IV every 6 weeks, the most common treatment-related adverse events were low-grade infusion reactions. There was fatigue and grade 1 cytokine release syndrome, what we call CRS. And no cases of neurotoxicity, or what we call ICANS, the immune effector cell-associated neurotoxicity syndrome, reported. Importantly, the CRS occurred in just about 8.9% of patients. All were grade 1. No patients required tocilizumab or discontinued treatment due to adverse events. So, this suggests a favorable safety profile, allowing hopefully for outpatient administration without hospitalization, which will be very important when we're thinking about bispecifics moving forward. In terms of efficacy, pasritamig showed promising activity. About 42.4% of evaluable patients achieved a PSA50 response. Radiographic PFS was about 6.8 months. And among patients with measurable disease, the objective response rate was about 16.1% in those with lymph node or bone metastases, and about 3.7% in those with visceral disease, with a median duration of response of about 11.3 months. So, altogether, this data suggests that pasritamig may offer a well-tolerated and active new potential option for patients with metastatic CRPC.   Again, as a reminder, with the caveat that this is still an early phase 1 study. Dr. Neeraj Agarwal: Thank you, Jeanny. These are promising results for a bispecific T-cell engager, pasritamig, in prostate cancer. I agree, the safety and durability observed here stand out, and this opens the door for further development, possibly even in earlier disease settings.  So, shifting now from immunotherapy to the evolving role of genomics in prostate cancer. So let's discuss Abstract 5094, a real-world, retrospective analysis exploring the prognostic impact of homologous recombination repair gene mutations, especially BRCA1 and BRCA2 mutations, in metastatic hormone-sensitive prostate cancer. Can you tell us more about this abstract, Jeanny? Dr. Jeanny Aragon-Ching: Sure, Neeraj. So this study was presented by Dr. David Olmos, represents one of the largest real-world analyses we have evaluating the impact of homologous recombination repair, or what we would call HRR, alterations in metastatic hormone-sensitive prostate cancer. So, this cohort included 556 men who underwent paired germline and somatic testing. Now, about 30% of patients had HRR alterations, with about 12% harboring BRCA1 or BRCA2 mutations and 16% having alterations in other HRR genes. Importantly, patients were stratified via CHAARTED disease volume, and outcomes were examined across treatment approaches, including ADT alone, doublet therapy, and triplet therapy. The prevalence of BRCA and HRR alterations were about similar between the metastatic hormone-sensitive prostate cancer and the metastatic castrate-resistant prostate cancer, with no differences observed, actually, between the patients with high volume versus low volume disease.  So, the key finding was that BRCA and HRR alterations were associated with poor clinical outcomes in metastatic hormone-sensitive prostate cancer. And notably, the impact of these alterations may actually be even greater in metastatic hormone-sensitive prostate cancer than previously reported in metastatic CRPC. So, the data showed that when BRCA mutations are present, the impact of the volume of disease is actually limited. So, poor outcomes were observed across the board for both high-volume and low-volume groups. So, the analysis showed that patients with HRR alterations had significantly worse outcomes compared to patients without HRR alterations. Median radiographic progression-free survival was about 20.5 months for the HRR-altered patients versus 30.6 months for the non-HRR patients, with a hazard ratio of 1.6. Median overall survival was 39 months for HRR-altered patients compared to 55.7 months for the non-HRR patients, with a hazard ratio of 1.5. Similar significant differences were observed when BRCA-mutant patients were compared with patients harboring non-BRCA HRR mutations. Overall, poor outcomes were independent of treatment of ARPI or taxanes. Dr. Neeraj Agarwal: Thank you, Jeanny. So, these data reinforce homologous recombination repair mutations as both a predictive and prognostic biomarker, not only in the mCRPC, but also in the metastatic hormone-sensitive setting as well. It also makes a strong case for incorporating genomic testing early in the disease course and not waiting until our patients have castration-resistant disease. Dr. Jeanny Aragon-Ching: Absolutely, Neeraj. And I think this really brings home the point and the lead up to the AMPLITUDE trial, which is LBA5006, a phase 3 trial that builds on this very concept of testing with a PARP inhibitor, niraparib, in the hormone-sensitive space. Can you tell us a little bit more about this abstract, Neeraj? Dr. Neeraj Agarwal: Sure. So, the AMPLITUDE trial, a phase 3 trial presented by Dr. Gerhardt Attard, enrolled 696 patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations. 56% of these patients had BRCA1 and BRCA2 mutations. Patients were randomized to receive abiraterone with or without niraparib, a PARP inhibitor. The majority of patients, 78% of these patients, had high-volume metastatic hormone-sensitive prostate cancer, and 87% of these patients had de novo metastatic HSPC. And 16% of these patients received prior docetaxel, which was allowed in the clinical trial. So, with a median follow-up of nearly 31 months, radiographic progression-free survival was significantly prolonged with the niraparib plus abiraterone combination, and median was not reached in this arm, compared to abiraterone alone, which was 29.5 months, with a hazard ratio of 0.63, translating to a 37% reduction in risk of progression or death. This benefit was even more pronounced in the BRCA1 and BRCA2 subgroup, with a 48% reduction in risk of progression, with a hazard ratio of 0.52. Time to symptomatic progression also improved significantly across all patients, including patients with BRCA1, BRCA2, and HRR mutations. Although overall survival data remain immature, early trends favored the niraparib plus abiraterone combination. The safety profile was consistent with prior PARP inhibitor studies, with grade 3 or higher anemia and hypertension were more common but manageable. Treatment discontinuation due to adverse events remained low at 11%, suggesting that timely dose modifications when our patients experience grade 3 side effects may allow our patients to continue treatment without discontinuation. These findings support niraparib plus abiraterone as a potential new standard of care in our patients with metastatic hormone-sensitive prostate cancer with HRR alterations, and especially in those who had BRCA1 and BRCA2 mutations. Dr. Jeanny Aragon-Ching: Thank you, Neeraj. This trial is especially exciting because it brings PARP inhibitors earlier into the treatment paradigm. Dr. Neeraj Agarwal: Exactly. And it is exciting to see the effect of PARP inhibitors in the earlier setting.  So Jeanny, now let's switch gears a bit to bladder cancer, which also saw several impactful studies. Could you tell us about Abstract 4502, an exploratory analysis from the EV-302 trial, which led to approval of enfortumab vedotin plus pembrolizumab for our patients with newly diagnosed metastatic bladder cancer? So here, the authors looked at the outcomes in patients who achieved a confirmed complete response with EV plus pembrolizumab. Dr. Jeanny Aragon-Ching: Sure, Neeraj. So, EV-302 demonstrated significant improvements in progression-free and overall survival for patients previously treated locally advanced or metastatic urothelial cancer, I'll just call it metastatic UC, as a frontline strategy, establishing EV, which is enfortumab vedotin, plus pembro, with pembrolizumab as standard of care in this setting.  So, this year at ASCO, Dr Shilpa Gupta presented this exploratory responder analysis from the phase 3 EV-302 trial. Among 886 randomized patients, about 30.4% of patients, this is about 133, in the EV+P arm, and 14.5% of the patients in the chemotherapy arm, achieved a confirmed complete response. They call it the CCR rates. So for patients who achieved this, median PFS was not reached with EV+P compared to 26.9 months with chemotherapy, with a hazard ratio of 0.36, translating to a 64% reduction in the risk of progression. Overall survival was also improved. So the median OS was not reached in either arm, but the hazard ratio favored the EV+P at 0.37, translating to a 63% reduction in the risk of death. The median duration of complete response was not reached with EV+P compared to 15.2 months with chemotherapy. And among those patients who had confirmed CRs at 24 months, 78% of patients with the EV+P arm remained progression-free, and around 95% of the patients were alive, compared to 54% of patients who were progression-free and 86% alive of the patients in the chemotherapy arm. Safety among responders were also consistent with prior reports. Grade 3 or higher treatment-related adverse events occurred in 62% of EV+P responders and 72% of chemotherapy responders. Most adverse events were managed with dose modifications, and importantly, no treatment-related deaths were reported among those who were able to achieve complete response.  So these findings further reinforce EV and pembro as the preferred first-line therapy for metastatic urothelial carcinoma, offering a higher likelihood of deep, durable responses with a fairly manageable safety profile. Dr. Neeraj Agarwal: Thank you for the great summary, Jeanny. These findings underscore the depth and durability of responses achievable with this combination and also suggest that achieving a response may be a surrogate for long-term benefit in patients with metastatic urothelial carcinoma.  So now, let's move to Abstract 4503, an exploratory ctDNA analysis from the NIAGARA trial, which evaluated perioperative durvalumab, an immune checkpoint inhibitor, in muscle-invasive bladder cancer. So what can you tell us about this abstract? Dr. Jeanny Aragon-Ching: Absolutely, Neeraj. So, in NIAGARA, presented by Dr. Tom Powles, the addition of perioperative durvalumab to neoadjuvant chemotherapy, gem/cis, significantly improved event-free survival, overall survival, and pathologic complete response in patients with cisplatin-eligible muscle-invasive bladder cancer. Recall that this led to the U.S. FDA approval of this treatment regimen on March 28, 2025.  So, a planned exploratory analysis evaluated the ctDNA dynamics and their association with clinical outcomes, which was the one presented recently at ASCO. So, the study found that the incidence of finding ctDNA positivity in these patients was about 57%. Following neoadjuvant treatment, this dropped to about 22%, with ctDNA clearance being more common in the durvalumab arm, about 41%, compared to the chemotherapy control arm of 31%. Notably, 97% of patients who remained ctDNA positive prior to surgery failed to achieve a pathologic CR. So, this indicates a strong association between ctDNA persistence and lack of tumor eradication. So, postoperatively, only about 9% of patients were ctDNA positive. So, importantly, durvalumab conferred an event-free survival benefit regardless of ctDNA status at both baseline and post-surgery. Among patients who were ctDNA positive at baseline, durvalumab led to a hazard ratio of 0.73 for EFS. So, this translates to a 27% reduction in the risk of disease recurrence, progression, or death compared to the control arm. In the post-surgical ctDNA-positive group, the disease-free survival was also improved with a hazard ratio of 0.49, translating to a 51% reduction in the risk of recurrence.  So, these findings underscore the prognostic value of ctDNA and suggest that durvalumab provides clinical benefit irrespective of molecular residual disease status. So, the data also supports that ctDNA is a promising biomarker for future personalized strategies in the perioperative treatment of muscle-invasive bladder cancer. Dr. Neeraj Agarwal: Thank you, Jeanny. It is great to see that durvalumab is improving outcomes in these patients regardless of ctDNA status. However, based on these data, presence of ctDNA in our patients warrants a closer follow-up with imaging studies, because these patients with positive ctDNA seem to have a higher risk of recurrence. Dr. Jeanny Aragon-Ching: I agree, Neeraj.  Let's round out the bladder cancer discussion with Abstract 4518, which reported the interim results of SURE-02, which is a phase 2 study evaluating neoadjuvant sacituzumab govitecan plus pembrolizumab in cisplatin-ineligible muscle-invasive bladder cancer. Can you tell us more about this abstract, Neeraj? Dr. Neeraj Agarwal: Sure, Jeanny. So, Dr Andrea Necchi presented interim results from the SURE-02 trial. This is a phase 2 study evaluating neoadjuvant sacituzumab govitecan plus pembrolizumab, followed by a response-adapted bladder-sparing treatment and adjuvant pembrolizumab in patients with muscle-invasive bladder cancer.  So, in this interim analysis, 40 patients were treated and 31 patients were evaluable for efficacy. So, the clinical complete response rate was 38.7%. All patients achieving clinical complete response underwent bladder-sparing approach with a repeat TURBT instead of radical cystectomy. Additionally, 51.6% of patients achieved excellent pathologic response with a T stage of 1 or less after neoadjuvant therapy. The treatment was well tolerated, with only 12.9% of patients experiencing grade 3 or higher adverse events without needing dose reduction of sacituzumab. Molecular profiling, interestingly, showed that clinical complete response correlated with luminal and genomically unstable subtypes, while high stromal gene expression was associated with lack of response.  These results suggest that sacituzumab plus pembrolizumab combination has promising activity in this setting, and tolerability, and along with other factors may potentially allow a bladder preservation approach in a substantial number of patients down the line. Dr. Jeanny Aragon-Ching: Yeah, agree with you, Neeraj. And the findings are very provocative and support completing the full trial enrollment and further exploration of this strategy in muscle-invasive bladder cancer in order to improve and provide further bladder-sparing strategies. Dr. Neeraj Agarwal: Agree. So, let's now turn to the kidney cancer, starting with Abstract 4505, the final overall analysis from CheckMate-214 trial, which evaluated nivolumab plus ipilimumab, so dual checkpoint inhibition strategy, versus sunitinib in our patients with metastatic clear cell renal cell carcinoma. Dr. Jeanny Aragon-Ching: Yeah, absolutely, Neeraj. So, the final 9-year analysis of the phase 3 CheckMate-214 trial confirms the long-term superiority of nivolumab and ipilimumab over sunitinib for first-line treatment of advanced metastatic renal cell carcinoma. So, this has a median follow-up of 9 years. Overall survival remains significantly improved with the combination. So, in the ITT patient population, the intention-to-treat, the hazard ratio for overall survival was 0.71. So, this translates to a 29% reduction in the risk of death. 31% of patients were alive at this 108-month follow-up compared to 20% only in those who got sunitinib. So, similar benefits were observed in the intermediate- and poor-risk groups with a hazard ratio of 0.69, and 30% versus 19% survival at 108 months.  Importantly, a delayed benefit was also seen in those favorable-risk patients. So, the hazard ratio for overall survival improved from 1.45 in the initial report and now at 0.8 at 9 years follow-up, with 35% of patients alive at 108 months compared to 22% in those who got sunitinib. Progression-free survival also favored the nivo-ipi arm across all risk groups. At 96 months, the probability of remaining progression-free was about 23% compared to 9% in the sunitinib arm in the ITT patient population, 25% versus 9% in the intermediate- and poor-risk patients, and 13% compared to 11% in the favorable-risk patients. Importantly, at 96 months, 48% of patients in the nivo-ipi responders remained in response compared to just 19% in those who got sunitinib. And in the favorable-risk group, 36% of patients who responded remained in response, although data were not available for sunitinib in this subgroup.  So, this data reinforces the use of nivolumab and ipilimumab as a durable and effective first-line effective strategy for standard of care across all risk groups for advanced renal cell carcinoma. Dr. Neeraj Agarwal: Thank you, Jeanny. And of course, since ipi-nivo data were presented, several other novel ICI-TKI combinations have emerged. And I'm really hoping to see very similar data with TKI-ICI combinations down the line. It is really important to note that we are not seeing any new safety signals with the ICI combinations or ICI-based therapies, which is very reassuring given the extended exposure. Dr. Jeanny Aragon-Ching: Absolutely agree with you there, Neeraj.  Now, going on and moving on to Abstract 4514, which is the KEYNOTE-564 trial, and they reported on the 5-year outcomes of adjuvant pembrolizumab in clear cell RCC in patients who are at high risk for recurrence. Can you tell us a little bit more about this abstract, Neeraj? Dr. Neeraj Agarwal: Sure. So, the KEYNOTE-564 trial established pembrolizumab monotherapy as the first adjuvant regimen to significantly improve both disease-free survival and overall survival compared to placebo after surgery for patients with clear cell renal cell carcinoma. So, Dr Naomi Haas presented the 5-year update from this landmark trial.  A total of 994 patients were randomized to receive either pembrolizumab or placebo. The median follow-up at the time of this analysis was approximately 70 months. Disease-free survival remained significantly improved with pembrolizumab. The median DFS was not reached with pembrolizumab compared to 68.3 months with placebo, with a hazard ratio of 0.71, translating to a 29% reduction in risk of recurrence. At 5 years, 60.9% of patients receiving pembrolizumab remained disease-free compared to 52.2% with placebo. Overall survival also favored pembrolizumab. The hazard ratio for OS was 0.66, translating to a 34% reduction in risk of death, with an estimated 5-year overall survival rate of 87.7% with pembrolizumab compared to 82.3% for placebo. Importantly, these benefits were consistent across all key subgroups, including patients with sarcomatoid features. In addition, no new serious treatment-related adverse events have been reported in the 3 years since treatment completion.  So, these long-term data confirm pembrolizumab as a durable and effective standard adjuvant therapy for patients with resected, high-risk clear cell renal cell carcinoma. Dr. Jeanny Aragon-Ching: Thank you for that wonderful summary, Neeraj. Dr. Neeraj Agarwal: That wraps up our kidney cancer highlights. Any closing thoughts, Jeanny, before we conclude? Dr. Jeanny Aragon-Ching: It's been so wonderful reviewing these abstracts with you, Neeraj. So, the 2025 ASCO Annual Meeting showcased a lot of transformative data across GU cancers, from first-in-class bispecifics to long-term survival in RCC. And these findings are already shaping our clinical practices. Dr. Neeraj Agarwal: I agree. And we have covered a broad spectrum of innovations in GU cancers with strong clinical relevance.  So, thank you, Jeanny, for joining me today and sharing your insights.  And thank you to our listeners for joining us. You will find links to the abstracts discussed today in the transcript of this episode. If you find these conversations valuable, please take a moment to rate, review, and subscribe to the ASCO Daily News Podcast wherever you listen. Thank you so much. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:    Dr. Neeraj Agarwal     @neerajaiims     Dr. Jeanny Aragon-Ching   Follow ASCO on social media:       @ASCO on Twitter       ASCO on Bluesky   ASCO on Facebook       ASCO on LinkedIn       Disclosures:   Dr. Neeraj Agarwal:   Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences  Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, Crispr Therapeutics, Arvinas  Dr. Jeanny Aragon-Ching:   Honoraria: Bristol-Myers Squibb, EMD Serono, Astellas Scientific and Medical Affairs Inc., Pfizer/EMD Serono   Consulting or Advisory Role: Algeta/Bayer, Dendreon, AstraZeneca, Janssen Biotech, Sanofi, EMD Serono, MedImmune, Bayer, Merck, Seattle Genetics, Pfizer, Immunomedics, Amgen, AVEO, Pfizer/Myovant, Exelixis,    Speakers' Bureau: Astellas Pharma, Janssen-Ortho, Bristol-Myers Squibb, Astellas/Seattle Genetics

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.The CDC's new vaccine advisors are meeting with an unexpected agenda today, including discussions on topics such as Sanofi and Gilead's protein degrader deals, the FDA's review of Sarepta's gene therapy, and a contentious hearing with RFK Jr. over vaccines. The meeting marks the beginning of a new era for the influential vaccine committee. The FDA has named a psychedelic proponent as CDER deputy director, while Nektar has declared a Phase IIb win for eczema treatment. Experts say conflicts of interest among axed ACIP members are a "red herring," and the pharma industry is facing turmoil in failed immuno-oncology projects. Prescription drug sales are projected to hit $1.75 trillion by 2030, thanks to GLP-1s. Transitioning to the next news, a major pharmaceutical company has announced a breakthrough in cancer research, potentially changing the landscape of treatment options for patients worldwide. This development comes at a time when the industry is seeing significant advancements in personalized medicine and targeted therapies. Moving on to regulatory updates, the FDA has recently approved a new drug for a rare disease, providing hope for patients who previously had limited treatment options. This decision showcases the agency's commitment to expediting the approval process for innovative therapies that address unmet medical needs. In other news, a biotech startup has secured funding for its groundbreaking technology that aims to revolutionize drug delivery methods. This investment highlights the growing interest in novel approaches to drug development and underscores the importance of innovation in the industry.Wrapping up today's episode, we take a look at the latest trends in digital health, with companies leveraging artificial intelligence and big data analytics to improve patient outcomes and streamline healthcare delivery. These technological advancements have the potential to transform the way healthcare is delivered and pave the way for a more efficient and patient-centric system. That's all for today's episode of Pharma and Biotech daily. Stay tuned for more updates on the latest developments in the pharmaceutical and biotechnology sectors.

In this podcast episode, Miguel Regueiro, MD, discusses developing the medical home model for patients with IBD, technological advances for patients in GI and more. •    Intro :58 •    The interview/about Regueiro 1:03 •    Tell us about your family and where you grew up. 1:24 •    How did you get interested in medicine? 2:16 •    Who were your early influences?  4:18 •    What is the medical home? 5:57 •    How did you develop the idea to apply the medical home model to IBD? 7:45 •    Did you get any funding from the payers for this model to keep costs under control for this patient population? 10:57 •    Why hasn't this model become standard of care for patients with complex IBD? 14:13 •    What has worked, and what hasn't worked when it comes to adopting an integrative care medical home model? 18:15 •    Are there themes patients share as to why they wouldn't want to be enrolled in a medical home? 21:28 •    What motivated your change to go from UPMC to become the GI Chief of Cleveland Clinic? 23:09 •    What have you learned in this position at Cleveland Clinic? 25:23 •    Are you spending a lot of time on the business side of care as opposed to the patient side? 26:34 •    How would you recommend that people prepare for having a position like this? 27:34 •    Are you seeing a shift in excitement over taking on leadership roles outside of traditional academics? 30:02 •    With our clinical tool chest changing so rapidly, is there a common theme that you use to guide the strategy of the institute on what to invest in? 35:06 •    What are the challenges that you still see in the ways we are using telehealth? 39:05 •    What are some of the most exciting things you see on the horizon in the realm of IBD management? 40:26 •    Thank you, Miguel 42:55 •    Thanks for listening 45:11 Miguel Regueiro, MD, is the chief of the Digestive Disease Institute at Cleveland Clinic, and professor in the department of medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. We'd love to hear from you! Send your comments/questions to guttalkpodcast@healio.com. Follow us on X @HealioGastro @sameerkberry @umfoodoc. For more from Regueiro, follow @MRegueiroMD on X. Disclosures: Berry and Chey report no relevant financial disclosures. Regueiro reports being on the advisory boards of and consulting for Abavax, Abbvie, Amgen, Biocon, BMS, Boehringer Ingelheim Pharmaceuticals Inc. (BIPI), Celgene, Celltrion, Gilead, Genentech, Johnson and Johnson, Lilly, Merck, Organon, Pfizer, Prometheus, Roche, Salix, Sanofi, Takeda and UBC.

Dr. Vamsi Velcheti and Dr. Nate Pennell discuss novel treatment approaches in small cell and non-small cell lung cancer that were featured at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Vamsi Velcheti: Hello, I'm Dr. Vamsi Velcheti, your guest host of the ASCO Daily News Podcast. I'm a professor of medicine and chief of hematology and oncology at the Mayo Clinic in Jacksonville, Florida. The 2025 ASCO Annual Meeting featured some exciting advancements in small cell lung cancer, targeted therapies for non-small cell lung cancer, and other novel [treatment] approaches. Today, I'm delighted to be joined by Dr. Nate Pennell to discuss some of the key abstracts that are advancing the lung cancer field. Dr. Pennell is the co-director of the Cleveland Clinic Lung Cancer Program and also the vice chair of clinical research at the Taussig Cancer Institute. Our full disclosures are available in the transcript of this episode. Nate, it's great to have you back on the podcast. Thanks so much for being here. Dr. Nate Pennell: Thanks, Vamsi. Always a pleasure. Dr. Vamsi Velcheti: Let's get started, and I think the first abstract that really caught my attention was Abstract 8516, “The Randomized Trial of Relevance of Time of Day of Immunotherapy for Progression-Free and Overall Survival in Patients With Non-Small Cell Lung Cancer.” What are your thoughts about this, Nate? Dr. Nate Pennell: I agree. I thought this was one of the most discussed abstracts, certainly in the lung cancer session, but I think even outside of lung cancer, it got some discussion. So, just to put this in perspective, there have been a number of publications that have all been remarkably consistent, and not just in lung cancer but across multiple cancer types, that immunotherapy, immune checkpoint inhibitors, are commonly used. And all of them have suggested, when looking at retrospective cohorts, that patients who receive immune checkpoint inhibitors earlier in the day – so in the morning or before the early afternoon – for whatever reason, appear to have better outcomes than those who get it later in the day, and this has been repeated. And I think many people just sort of assumed that this was some sort of strange association and that there was something fundamentally different from a prognostic standpoint in people who came in in the morning to get their treatment versus those who came later in the afternoon, and that was probably the explanation. The authors of this randomized trial actually decided to test this concept. And so, about 210 patients with previously untreated advanced non-small cell lung cancer were randomly assigned to get chemo and immune checkpoint inhibitor – either pembrolizumab or sintilimab – and half of them were randomly assigned to get the treatment before 3 PM in the afternoon, and half of them were assigned to get it after 3 PM in the afternoon. And it almost completely recapitulated what was seen in the retrospective cohorts. So, the median progression-free survival in those who got earlier treatment was 13.2 months versus only 6.5 months in those who got it later in the day. So, really enormous difference with a hazard ratio of 0.43, which was statistically significant. And perhaps even more striking, the median overall survival was not reached in the early group versus 17.8 months in the late group with a hazard ratio of 0.43, also highly statistically significant. Even the response rate was 20% higher in the early patients; 75% response rate compared to 56% in the late-time-of-day patients. So very consistent across all measures of efficacy with pretty good matched characteristics across the different groups. And so, I have to tell you, I don't know what to make of this. I certainly was a skeptic about the retrospective series, but now we have a prospective randomized trial that shows essentially the same thing. So, maybe there is a difference between getting treated in the morning, although I have yet to hear someone give a very good mechanistic explanation as to why this would be. What were your thoughts on this? Dr. Vamsi Velcheti: It's indeed fascinating, Nate, and I actually think this was a very interesting abstract. Really, I was caught off guard looking at the data. I mean, if it were a drug, we would be so excited, right? I mean, with those kind of survival benefits. I don't know. I think circadian rhythm probably has something to do with it, like different cytokine profiles at the time of administration. I mean, who knows? But I think it's a randomized trial, and I think I would expect to see a mad rush for treatment appointments early in the morning given this, and at least I want my patients to come in first thing in the morning. It'll be interesting to see. Dr. Nate Pennell: It's important to point out that in this study, everyone got chemo and immunotherapy. And, at least in our cancer center, most patients who are getting platinum-doublet chemotherapy and immunotherapy actually do get treated earlier in the day already, just because of the length of the infusion appointment that's needed. So it really is oftentimes people getting single-agent immunotherapy who are often getting the later, shorter visits. But if you have a choice, I think it would be very reasonable to have people treated earlier in the day. And I do think most of the impressions that I got from people about this is that they would like to see it reproduced but certainly well worth further investigation. And I personally would like to see more investigation into what the rationale would be for this because I still can't quite figure out, yes, if you got it at, say, you know, 5 PM, that's later in the day and I can understand that maybe your immune system is somewhat less receptive at that point than it would be in the morning. But because these checkpoint inhibitors have such long half-lives, it's still in your system the next morning when your immune system is supposedly more receptive. So I don't quite understand why that would be the case. Well, let's move on to the next study. I would like to hear your thoughts on Abstract 8515, “Plasma-Guided, Adaptive First-Line Chemoimmunotherapy for Non-Small Cell Lung Cancer.” Dr. Vamsi Velcheti: Yeah, this was another abstract that seems to be really interesting in my opinion. I think there's kind of a lot of emphasis lately on ctDNA and MRD-based assays to monitor disease. In the lung cancer space, we haven't had a lot of clinical trials looking at this prospectively, and this was one of those pilot studies where they looked at circulating free DNA (cfDNA)-based response-adaptive strategy for frontline patients who are PD-L1 positive. So, patients started with pembrolizumab monotherapy, and based on plasma molecular response after 2 cycles, those patients without response received early treatment intensification with a platinum doublet. So the approach essentially was to reduce the chemotherapy exposure in patients who respond to immunotherapy. And only about 17.5% of the patients on the trial received chemotherapy based on lack of molecular response. So, in this trial, what they found was patients with the cfDNA response had a markedly improved PFS of 16.4 months versus 4.8 months. So essentially, like, this is a really nice study to set a foundation on which we have to do larger studies to incorporate molecular markers trying to look at cfDNA response to inform treatment strategy, either escalation or de-escalation strategies. So, I thought it was a very interesting study. Dr. Nate Pennell: Yeah. I mean, we always have this question for patients, “Should they get immunotherapy alone or combined with chemo?” and I think this certainly is intriguing, suggesting that there may be ways you can monitor people and perhaps rescue those that aren't going to respond to single agent. I'd like to see a randomized trial against, you know, this strategy, perhaps against everyone getting, say, chemoimmunotherapy or make sure that you're not potentially harming people by doing this strategy. But I agree, it's time to move beyond just observing that cell-free DNA is prognostic and important and start using it to actually guide treatment. Dr. Vamsi Velcheti: Yeah, and I would just caution though, like, you know, I think we need more data, but, however, it's certainly a very interesting piece of data to kind of help inform future trials. So, there was another abstract that caught my attention, and I think this would be a very interesting abstract in the EGFR space. Abstract 8506, "Patritumab Deruxtecan (HER3-DXd) in Resistant EGFR-Mutant Advanced Non-Small Cell Lung Cancer Patients After Third-Generation EGFR TKI," it's the HERTHENA-Lung02 study. What do you think about the results of this study? Dr. Nate Pennell: Yeah, this was, I would say, very widely anticipated and ultimately a little disappointing, despite being a positive trial. So, these are patients with EGFR-mutant non-small cell lung cancer who have progressed after a third-generation EGFR TKI like osimertinib. This is really an area of major unmet need. We do have drugs like amivantamab in this space, but still definitely an area where essentially patients move from having a highly effective oral therapy to being in the realm of chemotherapy as their best option. So, this HER3 antibody-drug conjugate, patritumab deruxtecan, had some good single-arm data for this. And we're sort of hoping this would become an available option for patients. This trial was designed against platinum-doublet chemotherapy in this setting and with a primary endpoint of progression-free survival. And it actually was positive for improved progression-free survival compared to chemo with a hazard ratio of 0.77. But when you look at the medians, you can see that the median PFS was only 5.8 versus 5.4 months. It was really a modest difference between the two arms. And on the interim analysis, it appeared that there will not be a difference in overall survival between the two arms. In fact, the hazard ratio at the interim analysis was 0.98 for the two arms. So based on this, unfortunately, the company that developed the HER3-DXd has withdrawn their application to the FDA for approval of the drug, anticipating that they probably wouldn't get past approval without that overall survival endpoint. So, unfortunately, probably not, at least for the near future, going to be a new option for these patients. Dr. Vamsi Velcheti: Yeah, I think this is a space that's clearly an unmet need, and this was a big disappointment, I should say. I think all of us were going into the meeting anticipating some change in the standard of care here. Dr. Nate Pennell: Yeah, I agree. It was something that I was telling patients, honestly, that I was expecting this to be coming, and so now, definitely a bit of a disappointment. But it happens and, hopefully, it will still find perhaps a role or other drugs with a similar target. Certainly an active area. Well, let's leave the EGFR-mutant space and move into small cell. There were a couple of very impactful studies. And one of them was Abstract 8006, “Lurbinectedin Plus Atezolizumab as First-Line Maintenance Treatment in Patients With Extensive-Stage Small Cell Lung Cancer, Primary Results from the Phase III IMforte Trial.” So, what was your impression of this? Dr. Vamsi Velcheti: Yeah, I think this is definitely an interesting study, and small cell, I remember those days when we had barely any studies of small cell at ASCO, and now we have a lot of exciting developments in the small cell space. It's really good to see. The IMforte trial is essentially like a maintenance lurbinectedin trial with atezolizumab maintenance. And the study was a positive trial. The primary endpoint was a PFS, and the study showed improvement in both PFS and OS with the addition of lurbinectedin to atezolizumab maintenance. And definitely, it's a positive trial, met its primary endpoint, but I always am a little skeptical of adding maintenance cytotoxic therapies here in this setting. In my practice, and I'd like to hear your opinion, Nate, most patients with small cell after 4 cycles of a platinum doublet, they're kind of really beaten up. Adding more cytotoxic therapy in the maintenance space is going to be tough, I think, for a lot of patients. But also, most importantly, I think this rapidly evolving landscape for patients with small cell lung cancer with multiple new, exciting agents, actually like some FDA-approved like tarlatamab, also like a lot of these emerging therapeutics like I-DXd and other ADCs in this space. You kind of wonder, is it really optimal strategy to bring on like another cytotoxic agent right after induction chemotherapy, or do you kind of delay that? Or maybe have like a different strategy in terms of maintenance. I know that the tarlatamab maintenance trial is probably going to read out at some point too. I think it's a little challenging. The hazard ratio is also 0.73. As I said, it's a positive trial, but it's just incremental benefit of adding lurbi. And also on the trial, we need to also pay attention to the post-progression second-line treatments, number of patients who received tarlatamab or any other investigational agents.  So I think it's a lot of questions still. I'm not quite sure I'd be able to embrace this completely. I think a vast majority of my patients might not be eligible anyway for cytotoxic chemotherapy maintenance right away, but yeah, it's tough. Dr. Nate Pennell: Yeah. I would call this a single and not a home run. It definitely is real. It was a real overall survival benefit. Certainly not surprising that a maintenance therapy would improve progression-free survival. We've known that for a long time in small cell, but first to really show an overall survival benefit. But I completely agree with you. I mean, many people are not going to want to continue further cytotoxics after 4 cycles of platinum-doublet chemo. So I would say, for those that are young and healthy and fly through chemo without a lot of toxicity, I think certainly something worth mentioning. The problem with small cell, of course, is that so many people get sick so quickly while on that observation period after first-line chemo that they don't make it to second-line treatment. And so, giving everyone maintenance therapy essentially ensures everyone gets that second-line treatment. But they also lose that potentially precious few months where they feel good and normal and are able to be off of treatment. So, I would say this is something where we're really going to have to kind of sit and have that shared decision-making visit with patients and decide what's meaningful to them. Dr. Vamsi Velcheti: Yeah, I agree. The next abstract that was a Late-Breaking Abstract, 8000, “Overall Survival of Neoadjuvant Nivolumab Plus Chemotherapy in Patients With Resectable Non-Small Cell Lung Cancer in CheckMate-816.” This was a highly anticipated read-out of the OS data from 816. What did you make of this abstract? Dr. Nate Pennell: Yeah, I thought this was great. Of course, CheckMate-816 changed practice a number of years ago when it first reported out. So, this was the first of the neoadjuvant or perioperative chemoimmunotherapy studies in resectable non-small cell lung cancer. So, just to review, this was a phase 3 study for patients with what we would now consider stage II or stage IIIA resectable non-small cell lung cancer. And they received three cycles of either chemotherapy or chemotherapy plus nivolumab, and that was it. That was the whole treatment. No adjuvant treatment was given afterwards. They went to resection. And patients who received the chemoimmunotherapy had a much higher pathologic complete response rate and a much better event-free survival. And based on this, this regimen was approved and, I think, at least in the United States, widely adopted.  Now, since the first presentation of CheckMate 816, there have been a number of perioperative studies that have included an adjuvant component of immunotherapy – KEYNOTE-671, the AEGEAN study – and these also have shown improved outcomes. The KEYNOTE study with pembrolizumab also with an overall survival benefit. And I think people forgot a little bit about CheckMate-816. So, this was the 5-year overall survival final analysis. And it did show a statistically and, I think, clinically meaningful difference in overall survival with the 3 cycles of neoadjuvant chemo-nivo compared to chemo with a hazard ratio of 0.72. The 5-year overall survival of 65% in the chemo-IO group versus 55% with the chemo alone. So a meaningful improvement. And interestingly, that hazard ratio of 0.72 is very similar to what was seen in the peri-operative pembro study that included the adjuvant component. So, very much still relevant for people who think that perhaps the value of those neoadjuvant treatments might be really where most of the impact comes from this type of approach. They also gave us an update on those with pathologic complete response, showing really astronomically good outcomes. If you have a pathologic complete response, which was more than a quarter of patients, the long-term survival was just phenomenal. I mean, 95% alive at 5 years if they were in that group and suggesting that in those patients at least, the adjuvant treatment may not be all that important.  So, I think this was an exciting update and still leaves very much the open question about the importance of continuing immunotherapy after surgery after the neoadjuvant component. Dr. Vamsi Velcheti: Yeah, I completely agree, Nate. I think the million-dollar question is: “Is there like a population of patients who don't have complete response but like maybe close to complete response?” So, would you like still consider stopping adjuvant IO? I probably would not be comfortable, but I think sometimes, you know, we all have patients who are like very apprehensive of continuing treatments. So, I think that we really need more studies, especially for those patients who don't achieve a complete CR. I think trying to find strategies for like de-escalation based on MRD or other risk factors. But we need more trials in that space to inform not just de-escalation, but there are some patients who don't respond at all to a neoadjuvant IO. So, there may be an opportunity for escalating adjuvant therapies. So, it is an interesting space to watch out for. Dr. Nate Pennell: No, absolutely. Moving to KRAS-mutant space, so our very common situation in patients with non-small cell lung cancer, we had the results of Abstract 8500, “First-Line Adagrasib With Pembrolizumab in Patients With Advanced or Metastatic KRASG12C-Mutated Non-Small Cell Lung Cancer” from the phase 2 portion of the KRYSTAL-7 study. Why was this an interesting and important study? Dr. Vamsi Velcheti: First of all, there were attempts to kind of combine KRASG12C inhibitors in the past with immune checkpoint inhibitors, notably sotorasib with pembrolizumab. Unfortunately, those trials have led to like a lot of toxicity, with increased especially liver toxicity, which was a major issue. This is a phase 2 study of adagrasib in combination with pembrolizumab, and this is a study in the frontline setting in patients with the G12C-mutant metastatic non-small cell lung cancer. And across all the PD-L1 groups, the ORR was 44%, and the median PFS was 11 months, comparable to the previous data that we have seen with adagrasib in this setting. So it's not like a major improvement in clinical efficacy. However, I think the toxicity profile that we were seeing was slightly better than the previous trials in combination with sotorasib, but you still have a fair amount of transaminitis even in the study. At this point, this is not ready for clinical primetime. I don't think we should be using sotorasib or adagrasib in the frontline or even in the second line in combination with checkpoint inhibitors. Combining these drugs with checkpoint inhibitors in the clinical practice might lead to adverse outcomes. So, we need to wait for more data like newer-generation G12C inhibitors which are also being studied in combination, so we'll have to kind of wait for more data to emerge in this space. Dr. Nate Pennell: I agree, this is not immediately practice changing. This is really an attempt to try to combine targeted treatment with immune checkpoint inhibitor. And I agree with you that, you know, it does appear to be perhaps a little bit better tolerated than some of the prior combinations that have tried in this space. The outcomes overall were not that impressive, although in the PD-L1 greater than 50%, it did have a better response rate perhaps than you would expect with either drug alone. And I do think that the company is focusing on that population for a future randomized trial, which certainly would inform this question better. But in the meantime, I agree with you, there's a lot of newer drugs that are coming along that potentially may be more active and better tolerated. And so, I'd say for now, interesting but we'll wait and see. Dr. Vamsi Velcheti: Yeah, so now moving back again to small cell. So, there was a Late-Breaking Abstract, 8008. This is a study of tarlatamab versus chemotherapy as second-line treatment for small cell lung cancer. They presented the primary analysis of the phase III DeLLphi-304 study. What do you think about this? Dr. Nate Pennell: Yeah, I thought this was really exciting. This was, I would say, perhaps the most important lung study that was presented. Tarlatamab is, of course, the anti-DLL3 bispecific T-cell engager compound, which is already FDA approved based on a prior single-arm phase II study, which showed a very nice response rate as a single agent in previously treated small cell lung cancer and relatively manageable side effects, although somewhat unique to solid tumor docs in the use of these bispecific drugs in things like cytokine release syndrome and ICANS, the neurologic toxicities. So, this trial was important because tarlatamab was approved, but there were also other chemotherapy drugs approved in the previously treated space. And so, this was a head-to-head second-line competition comparison between tarlatamab and either topotecan, lurbinectedin, or amrubicin in previously treated small cell patients with a primary endpoint of overall survival. So, a very well-designed trial. And it did show, I think, a very impressive improvement in overall survival with a median overall survival in the tarlatamab group of 13.6 months compared to 8.3 months with chemotherapy, hazard ratio of 0.6. And progression-free survival was also longer at 4.2 months versus 3.2 months, hazard ratio of 0.72. In addition to showing improvements in cancer-related symptoms that were improved in tarlatamab compared to chemotherapy, there was actually also significantly lower rates of serious treatment-related adverse events with tarlatamab compared to chemotherapy. So, you do still see the cytokine release syndrome, which is seen in most people but is manageable because these patients are admitted to the hospital for the first two cycles, as well as a significant number of patients with neurologic side effects, the so-called ICANS, which also can be treated with steroids. And so, I think based upon the very significant improvement in outcomes, I would expect that this should become our kind of standard second-line treatment since it seems to be much better than chemo. However, tarlatamab is definitely a new drug that a lot of places are not used to using, and I think a lot of cancer centers, especially ones that aren't tied to a hospital, may have questions about how to deal with the CRS. So, I'm curious your thoughts on that. Dr. Vamsi Velcheti: Yeah, thank you, Nate. And I completely agree. I think the data looked really promising, and I've already been using tarlatamab in the second-line space. The durability of response and overall, having used tarlatamab quite a bit - like, I participated in some of the early trials and also used it as standard of care - tarlatamab has unique challenges in terms of like need for hospitalization for monitoring for the first few treatments and make sure, you know, we monitor those patients for CRS and ICANS. But once you get past that initial administration and monitoring of CRS, these patients have a much better quality of life, they're off chemotherapy, and I think it's really about the logistics of actually administering tarlatamab and coordination with the hospital and administration in the outpatient setting. It's definitely challenging, but I think it definitely can be done and should be done given what we are seeing in terms of clinical efficacy here. Dr. Nate Pennell: I agree. I think hospital systems now are just going to have to find a way to be able to get this on formulary and use it because it clearly seems to be more effective and generally better tolerated by patients. So, should move forward, I think. Finally, there's an abstract I wanted to ask you about, Abstract 8001, which is the “Neoadjuvant osimertinib with or without chemotherapy versus chemotherapy alone in resectable epidermal growth factor receptor-mutated non-small cell lung cancer: The NeoADAURA Study”. And this is one that I think was also fairly highly anticipated. So, what are your thoughts? Dr. Vamsi Velcheti: You know, I wasn't probably surprised with the results, and I believe we were all expecting a positive trial, and we certainly were handed a positive trial here. It's a phase III trial of osimertinib and chemotherapy or osimertinib in the neoadjuvant space followed by surgery, followed by osimertinib. It's a global phase 3 trial and very well conducted, and patients with stage II to stage IIIB were enrolled in the study. And in the trial, patients who had a neoadjuvant osimertinib with or without chemotherapy showed a significant improvement in major pathologic response rates over chemotherapy alone. And the EFS was also positive for osimertinib and chemotherapy, osimertinib monotherapy as well compared to chemotherapy alone. So overall, the study met its primary endpoint, and I think it sheds light on how we manage our patients with early-stage lung cancer. I think osimertinib, we know that osimertinib is already FDA approved in the adjuvant space, but what we didn't really know is how was osimertinib going to work in the neoadjuvant space. And there are always situations, especially for stage III patients, where we are on the fence about, are these patients already close to being metastatic? They have, like, almost all these patients have micrometastatic disease, even if they have stage III. As we saw in the LAURA data, when you look at the control arm, it was like a very short PFS. Chemoradiation does nothing for those patients, and I think these patients have systemic mets, either gross or micrometastatic disease at onset. So, it's really important to incorporate osimertinib early in the treatment course. And I think, especially for the locally advanced patients, I think it's even more important to kind of incorporate osimertinib in the neoadjuvant space and get effective local control with surgery and treat them with adjuvant. I'm curious to hear your thoughts, Nate. Dr. Nate Pennell: I am a believer and have long been a believer in targeted adjuvant treatments, and, you know, it has always bothered me somewhat that we're using our far and away most effective systemic therapy; we wait until after they go through all their pre-op treatments, they go through surgery, then they go through chemotherapy, and then finally months later, they get their osimertinib, and it still clearly improves survival in the adjuvant setting. Why not just start the osimertinib as soon as you know that the patient has EGFR-mutant non-small cell lung cancer, and then you can move on to surgery and adjuvant treatment afterwards? And I think what was remarkable about this study is that all of these patients almost - 90% in each arm - went to surgery. So, you weren't harming them with the neoadjuvant treatment. And clearly better major pathologic response, nodal downstaging, event-free survival was better. But I don't know that this trial is ever going to show an overall survival difference between neoadjuvant versus just surgery and adjuvant treatment, given how effective the drug is in the adjuvant setting. Nonetheless, I think the data is compelling enough to consider this, certainly for our N2-positive, stage IIIA patients or a IIIB who might be otherwise surgical candidates. I think based on this, I would certainly consider that. Dr. Vamsi Velcheti: Yeah, and especially for EGFR, like even for stage IIIB patients, in the light of the LAURA study, those patients who do not do too well with chemoradiation. So you're kind of delaying effective systemic therapy, as you said, waiting for the chemoradiation to finish. So I think probably time to revisit how we kind of manage these locally advanced EGFR patients. Dr. Nate Pennell: Yep, I agree. Dr. Vamsi Velcheti: Nate, thank you so much for sharing your fantastic insights today on the ASCO Daily News Podcast. It's been an exciting ASCO again. You know, we've seen a lot of positive trials impacting our care of non-small cell lung cancer and small cell lung cancer patients. Dr. Nate Pennell: Thanks for inviting me, Vamsi. Always a pleasure to discuss these with you. Dr. Vamsi Velcheti: And thanks to our listeners for your time today. You will find links to all of the abstracts discussed today in the transcript of the episode. Finally, if you value the insights that you hear from the ASCO Daily News Podcast, please take a moment to rate, review, subscribe wherever you get your podcast. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers:    Dr. Vamsi Velcheti   @VamsiVelcheti    Dr. Nathan Pennell   @n8pennell   Follow ASCO on social media:     @ASCO on Twitter     ASCO on Facebook     ASCO on LinkedIn   ASCO on BlueSky   Disclosures:   Dr. Vamsi Velcheti:   Honoraria: ITeos Therapeutics   Consulting or Advisory Role: Bristol-Myers Squibb, Merck, Foundation Medicine, AstraZeneca/MedImmune, Novartis, Lilly, EMD Serono, GSK, Amgen, Elevation Oncology, Taiho Oncology, Merus   Research Funding (Inst.): Genentech, Trovagene, Eisai, OncoPlex Diagnostics, Alkermes, NantOmics, Genoptix, Altor BioScience, Merck, Bristol-Myers Squibb, Atreca, Heat Biologics, Leap Therapeutics, RSIP Vision, GlaxoSmithKline   Dr. Nathan Pennell:     Consulting or Advisory Role: AstraZeneca, Lilly, Cota Healthcare, Merck, Bristol-Myers Squibb, Genentech, Amgen, G1 Therapeutics, Pfizer, Boehringer Ingelheim, Viosera, Xencor, Mirati Therapeutics, Janssen Oncology, Sanofi/Regeneron    Research Funding (Inst): Genentech, AstraZeneca, Merck, Loxo, Altor BioScience, Spectrum Pharmaceuticals, Bristol-Myers Squibb, Jounce Therapeutics, Mirati Therapeutics, Heat Biologics, WindMIL, Sanofi 

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/QPE865. CME/MOC/AAPA credit will be available until June 20, 2026.Advancing Care for Chronic Spontaneous Urticaria: Navigating an Evolving Treatment Landscape for Optimal Patient Outcomes In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical education grant from Sanofi and Regeneron Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/QPE865. CME/MOC/AAPA credit will be available until June 20, 2026.Advancing Care for Chronic Spontaneous Urticaria: Navigating an Evolving Treatment Landscape for Optimal Patient Outcomes In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical education grant from Sanofi and Regeneron Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

Dr. Shaalan Beg and Dr. Kristen Ciombor discuss practice-changing studies in GI cancers and other novel treatment approaches that were presented at the 2025 ASCO Annual Meeting. Transcript Dr. Shaalan Beg: Hello, I'm Dr. Shaalan Beg, welcoming you to the ASCO Daily News Podcast. I'm a medical oncologist and an adjunct associate professor at UT Southwestern Medical Center in Dallas, Texas. There were some remarkable advances in gastrointestinal cancers that were presented at the 2025 ASCO Annual Meeting, and I'm delighted to be joined by Dr. Kristen Ciombor to discuss some exciting GI data. Dr. Ciombor is the Ingram Associate Professor of Cancer Research and a co-leader of Translational Research and the Interventional Oncology Research Program at the Vanderbilt Ingram Cancer Center. Our full disclosures are available in the transcript of this episode. Dr. Ciombor, it's great to have you on the podcast today. Dr. Kristen Ciombor: Thanks, Dr Beg. It's great to be here. Dr. Shaalan Beg: Alright, let's kick it off. Big year for GI cancers. We'll start off with LBA1. This was the ATOMIC study sponsored by NCI and the National Clinical Trials Network (NCTN) and the Alliance group. This is a randomized study of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for stage III mismatch repair deficient colorectal cancer. Dr. Kristen Ciombor: I think this study was really definitely practice-changing, as you can tell because it was a Plenary. But I do have some concerns in terms of how we're actually going to implement this and whether this is the final answer in this disease subtype. So, as you said, the patients were enrolled with stage III resected mismatch repair deficient colon cancer, and then they were randomized to either modified FOLFOX6 with or without atezolizumab. And that's where it starts to become interesting because not many of us give FOLFOX for 6 months like was done in this study. Obviously, the study was done over many years, so that was part of that answer, but also the patients received atezolizumab for a total of 12 months. So the question, I think, that comes from this abstract is, is this practical and is this the final answer? I do think that this is practice-changing, and I will be talking to my patients with resected mismatch repair deficient colon cancer about FOLFOX plus atezolizumab. I think the big question is, do these patients need chemotherapy? And can we do a neoadjuvant approach instead? And that's where we don't have all the answers yet. Dr. Shaalan Beg: Yeah, but it has been great to see immunotherapy make its way into the adjuvant space after having made such a big impact in the metastatic space, but still some unanswered questions in terms of the need for chemotherapy and then the duration of therapy, which I guess we'll have to stay tuned in for the next couple of years to to get a lot of those questions answered. Dr. Kristen Ciombor: Yeah, but a big congratulations to the study team, to the NCTN, the NCI. I mean, this is really a great example of federally funded research that needs to continue. So, great job by the study team. The DFS 10% difference is really very large and certainly a practice-changing study. Dr. Shaalan Beg: Yeah, and and sticking with colon cancer, and and this another federally funded study, but this time funded by a Canadian cancer clinical trials group was LBA3510. This is the CHALLENGE study. It's a randomized phase 3 trial of the impact of a structured exercise program on disease-free survival for stage III or high-risk stage II colon cancer. This study got a lot of buzz, a lot of mainstream press coverage, and a lot of discussions on what that means for us for the patients who we're going to be seeing next week in our clinic. What was your takeaway? Dr. Kristen Ciombor: Yeah, this is a really interesting study, and I was so glad to see it presented because this partially answers one of the questions that patients always have for us in clinic, right? You know, once they've completed their standard chemotherapy and surgery, what else can they do to help prevent recurrence? And so we've always known and sort of extrapolated that healthy lifestyle habits are good, but now we have data, particularly in these patients. Most of them were stage III colon cancer patients, those had high-risk stage II cancer. And basically, the goal was to increase their physical activity by at least 10 MET hours per week. So, my big question, of course, as I came into this presentation was, “Okay, what does that mean exactly? How does that translate to real life?” And really what the author presented and explained was that basically most patients could hit their target by adding a 45- to 60-minute brisk walk 3 to 4 times a week. So I think this is very approachable.  Now, in the confines of the study, this was a structured exercise program, so it wasn't just patients doing this on their own. But I do think kind of extrapolating from that, that this is very achievable for most patients. And not only did this prevent recurrence of their prior cancer, but actually the rate of new primary cancer diagnoses, was less, which is really interesting, especially in the breast and prostate cancer. So this was a really interesting, and I think practice-changing study as well, especially given that this is something that most patients can do. Dr. Shaalan Beg: Yeah, and there was a lot of discussion in the hallways after the presentation in terms of how this really changes our existing practice because most folks already recommend exercise as a way for improving outcomes in cancer patients. So we've already been doing that. Now we have some data on how much it can impact the benefit. But there was some discussion about what the actual degree of impact was. There was a drop-off rate in terms of how long folks were able to stick with this exercise regimen. But you've seen this in clinic when someone have their surgery, they have their chemotherapy, they've been so intimately involved with the oncology world, with the oncology practice, and they somehow feel that they're being let loose into this mean, angry world without any guidance and they're looking for something to do. “What more can I do in terms of my lifestyle?” And then here we have very solid data, as solid as can be for an intervention like exercise, showing that there is an impact and you can give a prescription for exercise when someone wraps up their chemotherapy for colon cancer, thanks to the study. Dr. Kristen Ciombor: Yeah. It was a great study. Dr. Shaalan Beg: Moving to gastroesophageal cancer, another late-breaking abstract. This is LBA5. The MATTERHORN trial was a phase 3 trial of durvalumab plus FLOT for resectable GE junction and gastric cancer. And again, another area where immunotherapy has made an impact, and here we're seeing it move closer for earlier-stage disease. What was your take-home for the MATTERHORN trial? Dr. Kristen Ciombor: Yeah, so this study looked at neoadjuvant perioperative durvalumab plus our current standard chemotherapy of FLOT versus placebo plus FLOT. And this was a large study, almost 1,000 patients were randomized. And the primary endpoint was event-free survival, and it was definitely met in favor of the D + FLOT arm, as Dr. Klempner discussed after Dr Janjigian's presentation. I do think there are still some unanswered questions here. Overall survival is not yet mature, so we do have to wait and see how that shakes out. But it's very interesting and kind of is reflective of what, as you said, we're looking at earlier and earlier lines of therapy, particularly with immunotherapy, in these GI cancer spaces. So it makes a lot of sense to test this and and to look at this. So the toxicity was pretty similar to what we would expect. Primary endpoint was met, but again, we'll have to wait and see what the survival data looks like. Dr. Shaalan Beg: Yeah, and in oncology, we know, especially for treatment that does add additional cost, it does add additional potential toxicity that we want to see that overall survival nudged. I did see some polls on social media asking folks whether their practices changed from this, and I think the results were favoring adding durvalumab for this group of patients but understanding that there are caveats to the addition of treatments and the eventual FDA approval in that indication as well. Dr. Kristen Ciombor: Exactly. I completely agree with that. Dr. Shaalan Beg: All right. How about we stick with gastroesophageal cancer? LBA4002 was trastuzumab deruxtecan versus ramucirumab plus paclitaxel for second-line treatment in HER2-positive unresectable or metastatic gastric cancer or GE junction cancer. This was the DESTINY-Gastric04 study. And again, antibody-drug conjugates making a big impact across different diseases. And here we have more data in the HER2-positive gastric cancer space. Your thoughts on this study? Dr. Kristen Ciombor: Yeah, so this is a really important space in gastroesophageal cancer because the HER2 positivity rate is fairly high as compared to some of our other tumor types. So, I do think one of the important things was that patients did have biopsy confirmation of HER2 status, which was very important, and then they were randomized to either T-DXd versus the kind of second-line standard of ramucirumab-paclitaxel. So this was a great practical study and really answers a question that we had for a while in terms of does anti-HER2 therapy in the second-line really impact and improve survival. So we did see a statistically significant improvement favoring T-DXd. I do think it's always important to look at toxicity, though, too. And there was about almost 14% rate of interstitial lung disease, which of course is the most feared toxicity from some of these antibody-drug conjugates, especially T-DXd. So I do think it's important to keep that in mind, but this is definitely a great addition to the armamentarium for these HER2-positive patients. Dr. Shaalan Beg: And pancreas cancer was on the stage after a very long time with a positive clinical trial. This is Abstract 4006. These were preliminary results from a phase 2 study of elraglusib in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel alone for previously untreated metastatic pancreas cancer. This is a frontline clinical trial of gemcitabine/nab-paclitaxel plus/minus the study drug. There were other cohorts in this study as well, but they reported the results of their part 3B arm. And great to see some activity in the pancreas space. And your thoughts? Dr. Kristen Ciombor: Yeah, we definitely need better treatments in pancreas cancer. This was a very welcome presentation to see. The elraglusib is an inhibitor of GSK-3beta, and it's thought that that mediates drug resistance and EMT. And so this is, I think, a perfect setting to test this drug. So patients basically were randomized. Patients with metastatic pancreas cancer were randomized 2: 1 to gemcitabine/nab-paclitaxel plus or minus this elraglusib. So, what we saw was that overall survival was better with the addition of this new drug. And overall, not only the 1-year overall survival, but also median overall survival.  The thing that was interesting, though, was that we saw that the overall survival rates were 9.3 months with the combination versus 7.2 months with just gemcitabine/nab-paclitaxel. And that's a little bit lower than we've seen in other studies. So, not sure what was going on there. Was it the patients that were a bit sicker? Was it a patient selection, you know, thing? I'm not really sure how to explain that so much. Also, the toxicity profile was much higher in terms of visual impairment, with over 60% of patients being treated with the combination versus 9% with gemcitabine/nab-paclitaxel. So these were mild, grade 1 and 2, but still something to be cautious about. Dr. Shaalan Beg: And especially with this being a phase 2 trial, making sure that in a larger study we're able to better evaluate the toxicity and see if the control arm in the larger confirmatory study performs differently will be really important before this compound makes it to the clinic in our space. But very exciting to see these kinds of results for pancreas adenocarcinoma. Dr. Kristen Ciombor: Yeah. Dr. Shaalan Beg: We've talked, it seems, a couple of times on this podcast about the BREAKWATER clinical trial. We did hear PFS and updated OS data, updated overall survival data on first-line encorafenib plus cetuximab plus modified FOLFOX6 for BRAF-mutated colorectal cancer. This was LBA3500. And eagerly anticipated results – we have all previously heard the progression-free survival results – but here we heard updated overall survival results, and very well-received study it seemed from the audience that time. So what are your takeaways on the updated results for BREAKWATER? Dr. Kristen Ciombor: In my opinion, this was one of the most practice-confirming studies. As you mentioned, we've already seen some of the preliminary data of BREAKWATER at prior meetings. But really what was particularly impactful for me was the median overall survival with the BREAKWATER regimen. So, again, patients received FOLFOX, encorafenib cetuximab in the first line if they had BRAF-mutated V600E-mutated colorectal cancer. And the median PFS was 12.8 months, which was actually really remarkable in this traditionally very aggressive, poor prognosis subtype of tumors. So, by seeing a median overall survival of 30.3 months was just incredible, in my opinion. Just a few years ago, that was considered the median overall survival for all comers for metastatic colorectal cancer. And we know the median overall survival was more in the less than 12 months range for BRAF. So this was incredibly impactful, and I think should be absolutely practice-changing for anyone who is eligible for this regimen.  I think again, where the practice meets the study is what's kind of important to think about too, how long did patients get FOLFOX, and certainly it adds toxicity to add a BRAF-targeted regimen on top of FOLFOX already. So, one of the other interesting things about the study, though, was that even though it didn't complete treatment, they actually did look at encorafenib/cetuximab alone and in the first line without chemotherapy. And those preliminary results actually looked okay, especially for patients who might not be able to tolerate chemotherapy, which we certainly see in practice. So, overall, definitely more data. And I agree that it's certainly practice-changing. Dr. Shaalan Beg: And it completely, as you mentioned, changes the outlook for a person who's diagnosed with BRAF-mutated metastatic colon cancer today versus even 7 or 8 years ago. Dr. Kristen Ciombor: And we're seeing this over and over in other subtypes too, but how you choose to treat the patient up front really matters. So really giving the right regimen up front is the key here. Dr. Shaalan Beg: And along the same lines, Abstract 3501 wanted to answer the question on whether people with MSI-high metastatic colorectal cancer need double checkpoint inhibitor therapy or is single therapy enough. So this [CheckMate-8HW] study compared nivo plus ipi with nivo alone, nivo monotherapy for MSI-high metastatic colorectal cancer. And we've known that both of these are fairly active regimens, but we also know the chance of immune-related adverse events is significantly higher with combination therapy. So this was a much-needed study for this group of patients. And what were your takeaways here? Dr. Kristen Ciombor: This, of course, has been really nivo-ipi in the first-line MSI-high metastatic colorectal cancer is now a standard of care. And not everybody is eligible for it, and there could be reasons, toxicity reasons, and other things too. But as we've been seeing for the last couple of years, immunotherapy clearly beats chemo in this space. And now looking at doublet versus single immunotherapy treatment in the first line, I think really nivo-ipi does beat out monotherapy. I will say, however, there is a caveat in that we still haven't seen the nivo-ipi versus nivo in the first line. So what has been presented thus far has been across all lines of therapy, and that does muddy the waters a little bit. So definitely looking forward and and we've asked this many times and based on the statistical plan and and what not, you know, we just haven't seen that data yet. But I do think it's becoming increasingly important to consider doublet immunotherapy for these patients as long as there are no contraindications. With the again, with the caveat that we have to have these toxicity discussions in the clinic with patients because many patients can tolerate it, you know, this regimen fairly well, but there can be very severe toxicities. So, I think an informed discussion should really be had with each patient before moving forward. Dr. Shaalan Beg: Yeah, informed decision, making them aware of the potential of real significant toxicities, immune-related toxicities with double therapy. But I am curious in your practice, how often do you see people choosing doublet therapy as frontline? Dr. Kristen Ciombor: So patients are really savvy, and a lot of times they've heard this data before or have come across it in patient advocacy groups and other things, and it's really nice to be able to have that conversation of the risk versus benefit. So I will say not all of my patients choose doublet, and many of them are still cured with immunotherapy monotherapy. So the big question there is, will we ever understand who actually needs the doublet versus who can still be cured or have very good long-term outcomes with just the single agent? And that has not been answered yet. Dr. Shaalan Beg: What a great point. So the last abstract I was hoping we could talk about is POD1UM-303 or the INTERAACT2 subgroup analysis and impact of delayed retifanlimab treatment for patients with squamous cell carcinoma of the anal canal. What were your thoughts here? Dr. Kristen Ciombor: This was a study, actually we saw at ESMO, we saw the primary data at ESMO last year, and this was an update with some exploratory analyses. But this was really an important study because once again, we're looking at immunotherapy in later lines of therapy. That's how we started looking at and investigating immunotherapy, and now we're moving it up and up in the treatment course. So this was a study of carboplatin/paclitaxel plus or minus retifanlimab. Actually it was retifanlimab versus placebo. And it was a positive study, as we heard last year. This actually led to FDA approval of this regimen last month, just before ASCO, and it has now been incorporated in the NCCN guidelines as the preferred first-line option.  So what I thought was important from the additional data presented at ASCO was looking at the different subgroups, it did not appear that patients with liver mets or not had different outcomes. So that was really good to see because sometimes in colon cancer we see that immunotherapy doesn't work as well when patients have liver mets. And interestingly, because we use immunotherapy in anal cancer without any biomarkers, unlike with colon cancer or some of the other tumor types, also the authors looked at PD-L1 status, and it did look like maybe patients did a little bit better if they had higher PD-L1 expression, but patients still could benefit even if they were PD-L1 negative. So that was important, I think, and we will continue to see further data come out from this study. I want to mention also that EA2176 just completed accrual, so that was carbo-taxol plus or minus nivolumab. And so we should be seeing that data sometime soon, which will hopefully also confirm the ongoing role for immunotherapy in the first-line setting for anal cancer. Dr. Shaalan Beg: That was a fantastic review. Thank you, Dr Ciombor. Thanks for sharing your valuable insights with us today on the ASCO Daily News Podcast. Dr. Kristen Ciombor: Thanks for having me here. Dr. Shaalan Beg: And thank you to our listeners for your time today. You will find links to the abstracts discussed today in the transcript of this episode. And if you value the insights that you hear on the podcast, please take a moment to rate, review, and subscribe, wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers:   Dr. Shaalan Beg  @ShaalanBeg  Dr. Kristen Ciombor @KristenCiombor Follow ASCO on social media:    @ASCO on Twitter   @ASCO on BlueSky  ASCO on Facebook    ASCO on LinkedIn    Disclosures:   Dr. Shaalan Beg:   Consulting or Advisory Role: Ipsen, Cancer Commons, Foundation Medicine, Science37, Nant Health, Lindus Health Speakers' Bureau: Sirtex Research Funding (Inst.): Delfi Diagnostics, Universal Diagnostics, Freenome Dr. Kristen Ciombor: Consulting or Advisory Role: Pfizer, Incyte, Exelixis, Bayer, ALX Oncology, Tempus, Agenus, Taiho Oncology, Merck, BeiGene Research Funding (Inst.): Pfizer, Boston Biomedical, MedImmune, Onyx, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Novartis, Incyte, Amgen, Sanofi, Bristol-Myers Squibb, Array BioPharma, Incyte, Daiichi Sankyo, Nucana, Abbvie, Merck, Pfizer/Calthera, Genentech, Seagen, Syndax Travel, Accommodations, Expenses: Incyte, Tempus

A gripe pode causar complicações graves e, por ser uma doença comum, muitas vezes é subestimada. Por isso, é importante entender melhor como ocorre a infecção pelo vírus Influenza e quais complicações ela pode provocar.Neste Drauziocast, a dra. Maisa Kairalla, médica geriatra, e o dr. Drauzio Varella explicam quais são os grupos de risco para a doença, os tipos de imunização disponíveis e as formas mais eficazes de prevenção. Por fim, discutem o impacto da gripe na saúde pública. Assista!Conteúdo produzido em parceria com a Sanofi.MAT-BR-2501188 - Junho/2025Veja também: Por que é tão importante tomar a vacina da gripe?

Description: Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Sciences Advisory Council, interview Anna Henderson, MD, a pediatric gastroenterologist at Northern Light Health in Maine, about bone mineral density in EoE patients. They discuss a paper she co-authored on the subject. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship that exists between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:50] Co-host Ryan Piansky introduces the episode, brought to you thanks to the support of Education Partners Bristol Myers Squibb, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:17] Holly introduces today's topic, eosinophilic esophagitis (EoE), and bone density.   [1:22] Holly introduces today's guest, Dr. Anna Henderson, a pediatric gastroenterologist at Northern Light Health in Maine.   [1:29] During her pediatric and pediatric gastroenterology training at Cincinnati Children's Hospital, she took a special interest in eosinophilic esophagitis. In 2019, Dr. Henderson received APFED's NASPGHAN Outstanding EGID Abstract Award.   [1:45] Holly, a feeding therapist in Maine, has referred many patients to Dr. Henderson and is excited to have her on the show.   [2:29] Dr. Henderson is a wife and mother. She loves to swim and loves the outdoors. She practices general pediatric GI in Bangor, Maine, at a community-based academic center.   [2:52] Her patient population is the northern two-thirds of Maine. Dr. Henderson feels it is rewarding to bring her expertise from Cincinnati to a community that may not otherwise have access to specialized care.   [3:13] Dr. Henderson's interest in EoE grew as a GI fellow at Cincinnati Children's. Her research focused on biomarkers for disease response to dietary therapies and EoE's relationship to bone health.   [3:36] As a fellow, Dr. Henderson rotated through different specialized clinics. She saw there were many unanswered questions about the disease process, areas to improve treatment options, and quality of life for the patients suffering from these diseases.   [4:00] Dr. Henderson saw many patients going through endoscopies. She saw the social barriers for patients following strict diets. She saw a huge need in EoE and jumped on it.   [4:20] Ryan grew up with EoE. He remembers the struggles of constant scopes, different treatment options, and dietary therapy. Many people struggled to find what was best for them before there was a good approved treatment.   [4:38] As part of Ryan's journey, he learned he has osteoporosis. He was diagnosed at age 18 or 19. His DEXA scan had such a low Z-score that they thought the machine was broken. He was retested.   [5:12] Dr. Henderson explains that bone mineral density is a key measure of bone health and strength. Denser bones contain more minerals and are stronger. A low bone mineral density means weaker bones. Weaker bones increase the risk of fracture.   [5:36] DEXA scan stands for Dual Energy X-ray Absorptiometry scan. It's a type of X-ray that takes 10 to 30 minutes. A machine scans over their bones. Typically, we're most interested in the lumbar spine and hip bones.   [5:56] The results are standardized to the patient's height and weight, with 0 being the average. A negative number means weaker bones than average for that patient's height and weight. Anything positive means stronger bones for that patient's height and weight.   [6:34] A lot of things can affect a patient's bone mineral density: genetics, dietary history, calcium and Vitamin D intake, and medications, including steroid use. Prednisone is a big risk factor for bone disease.   [7:07] Other risk factors are medical and auto-immune conditions, like celiac disease, and age. Any patient will have their highest bone density in their 20s to 30s. Females typically have lower bone mineral density than males.   [7:26] The last factor is lifestyle. Patients who are more active and do weight-bearing exercises will have higher bone mineral density than patients who have more of a sedentary lifestyle.   [7:56] Ryan was told his bone mineral density issues were probably a side-effect of the long-term steroids he was on for his EoE. Ryan is now on benralizumab for eosinophilic asthma. He is off steroids.   [8:36] Dr. Henderson says the research is needed to find causes of bone mineral density loss besides glucocorticoids.   [8:45] EoE patients are on swallowed steroids, fluticasone, budesonide, etc. Other patients are on steroids for asthma, eczema, and allergic rhinitis. These may be intranasal steroids or topical steroids.   [9:01] Dr. Henderson says we wondered whether or not all of those steroids and those combined risks put the EoE population at risk for low bone mineral density. There's not a lot published in that area.   [9:14] We know that proton pump inhibitors can increase the risk of low bone mineral density. A lot of EoE patients are on proton pump inhibitors.   [9:23] That was where Dr. Henderson's interest started. She didn't have a great way to screen for bone mineral density issues or even know if it was a problem in her patients more than was expected in a typical patient population.   [9:57] Holly wasn't diagnosed with EoE until she was in her late 20s. She was undiagnosed but was given prednisone for her problems. Now she wonders if she should get a DEXA scan.   [10:15] Holly hopes the listeners will learn something and advocate for themselves or for their children.   [10:52] If a patient is concerned about their bone mineral density, talking to your PCP is a perfect place to start. They can discuss the risk factors and order a DEXA scan and interpret it, if needed.   [11:11] If osteoporosis is diagnosed, you should see an endocrinologist, specifically to discuss therapy, including medications called bisphosphonates.   [11:36] From an EoE perspective, patients can talk to their gastroenterologist about what bone mineral density risk factors may be and if multiple risk factors exist. Gastroenterologists are also more than capable of ordering DEXA scans and helping their patients along that journey.   [11:53] A DEXA scan is typically the way to measure bone mineral density. It's low radiation, it's easy, it's fast, and relatively inexpensive.   [12:10] It's also useful in following up over time in response to different interventions, whether or not that's stopping medications or starting medications.   [12:30] Dr. Henderson co-authored a paper in the Journal of Pediatric Gastroenterology and Nutrition, called “Prevalence and Predictors of Compromised Bone Mineral Density in Pediatric Eosinophilic Esophagitis.” The study looked at potential variables.   [12:59] The researchers were looking at chronic systemic steroid use. They thought it was an issue in their patients, especially patients with multiple atopic diseases like asthma, eczema, and allergic rhinitis. That's where the study started.   [13:22] Over the years, proton pump inhibitors have become more ubiquitous, and more research has come out. The study tried to find out if this was an issue or not. There weren't any guidelines for following these patients, as it was a retrospective study.    [13:42] At the time, Dr. Henderson was at a large institution with a huge EoE population. She saw that she could do a study and gather a lot of information on a large population of patients. Studies like this are the start of figuring out the guidelines for the future.   [14:34] Dr. Henderson wanted to determine whether pediatric patients with EoE had a lower-than-expected bone mineral density, compared to their peers. [14:44] Then, if there were deficits, she wanted to determine where they were more pronounced. Were they more pronounced in certain subgroups of patients with EoE?   [14:59] Were they patients with an elemental diet? Patients with an elimination diet? Were they patients on steroids or PPIs? Were they patients with multiple atopic diseases? Is low bone mineral density just a manifestation of their disease processes?   [15:14] Do patients with active EoE have a greater propensity to have low bone mineral density? The study was diving into see what the potential risk factors are for this patient population.   [15:45] The study was a retrospective chart review. They looked at patients aged 3 to 21. You can't do a DEXA scan on a younger patient, and 21 is when people leave pediatrics.   [16:03] These were all patients who had the diagnosis of EoE and were seen at Cincinnati Children's in the period between 2014 and 2017. That period enabled full ability for chart review. Then they looked at the patients who had DEXA scans.   [16:20] They did a manual chart review of all of the patients and tried to tease out what the potential exposures were. They looked at demographics, age, sex, the age of the diagnosis of EoE, medications used, such as PPIs, and all different swallowed steroids.   [16:44] They got as complete a dietary history as they could: whether or not patients were on an elemental diet, whether that was a full elemental diet, whether they were on a five-food, six-food, or cow's milk elimination diet.   [16:58] They teased out as much as they could. One of the limitations of a retrospective chart review is that you can't get some of the details, compared to doing a prospective study. For example, they couldn't tease out the dosing or length of therapy, as they would have liked.   [17:19] They classified those exposures as whether or not the patient was ever exposed to those medications, whether or not they were taking them at the time of the DEXA scan, or if they had been exposed within the year before the DEXA scan.   [17:40] They also looked at whether the patients had other comorbid atopic disorders, to see if those played a role, as well.   [18:03] The study found that there was a slightly lower-than-expected bone mineral density in the patients. The score was -0.55, lower than average but not diagnostic of a low bone mineral density, which would be -2 or below.   [18:27] There were 23 patients with low bone mineral density scores of -2 or below. That was 8.6% of the study patients. Typically, only 2.5% of the population would have that score. It was hard to tease out the specific risk factors in a small population of 23.   [18:57] They looked at what the specific risk factors were that were associated with low bone mineral density, or bone mineral density in general.   [19:12] After moving from Colorado, Holly has transferred to a new care team, and doctors wanted her baseline Vitamin D and Calcium levels. No one had ever tested that on her before. Dr. Henderson says it's hard because there's nothing published on what to do.   [19:58] The biggest surprise in the study was that swallowed steroids, or even combined steroid exposure, didn't have any effect on bone mineral density. That was reassuring, in light of what is known about glucocorticoid use.   [20:16] The impact of PPI use was interesting. The study found that any lifetime use of PPIs did seem to decrease bone mineral density. It was difficult to tease out the dosing and the time that a patient was on PPIs.   [20:34] Dr. Henderson thinks that any lifetime use of PPIs is more of a representation of their cumulative use of PPIs. At the time of the study, from 2014 to 2017, PPIs were still very much first-line therapy for EoE; 97% of the study patients had taken PPIs at some time.   [21:02] There are so many more options now for therapy when a patient has a new diagnosis of EoE, especially with dupilumab now being an option.   [21:11] Dr. Henderson speaks of patients who started on PPIs and have stayed on them for years. This study allows her to question whether we need to continue patients on PPIs. When do we discuss weaning patients off PPIs, if appropriate?   [22:05] Ryan says these podcasts are a great opportunity for the community at large and also for the hosts. He just wrote himself a note to ask his endocrinologist about coming off PPIs.   [22:43] Dr. Henderson says that glucocorticoid use is a known risk factor for low bone mineral density and osteoporosis. In the asthma population, inhaled steroids can slightly decrease someone's growth potential while the patient is taking them.   [23:10] From those two facts, it was thought that swallowed steroids would have a similar effect. But since they're swallowed and not systemic, maybe things are different.   [23:23] It was reassuring to Dr. Henderson that what her study found was that the swallowed steroid didn't affect bone mineral density. There was one other study that found that swallowed steroids for EoE did not affect someone's height.   [23:51] Dr. Henderson clarifies that glucocorticoids include systemic steroids like prednisone and hydrocortisone.     [23:57] Based on Dr. Henderson's retrospective study, fluticasone as a swallowed steroid did not affect bone mineral density. It was hard to tease out the dosing, but the cumulative use did not seem to result in a deficit for bone mineral density.   [24:16] Holly shared that when she tells a family of a child she works with that the child's gastroenterologist will likely recommend steroids, she will now give them the two papers Dr. Henderson mentioned. There are different types of steroids. The average person doesn't know the difference.   [25:15] Dr. Henderson thinks that for patients who have multiple risk factors for low bone mineral density, it is reasonable to have a conversation about bone health with their gastroenterologist to see whether or not a DEXA scan would be worth it.   [25:56] If low bone mineral density is found, that needs to be followed up on.   [26:03] There are no great guidelines, but this study is a good start on what these potential risk factors are. We need some more prospective studies to look at these risk factors in more detail than Dr. Henderson's team teased out in this retrospective study.   [26:23] Dr. Henderson tells how important it is for patients to participate in prospective longitudinal studies for developing future guidelines.   [26:34] Holly points out that a lot of patients are on restrictive diets. It's important to think about the whole picture if you are starting a medication or an elimination, or a restricted diet. You have to think about the impact on your body, overall.   [27:11] People don't think of dietary therapy as medication, but it has risks and benefits involved, like a medication.   [27:50] Dr. Henderson says, in general, lifestyle management is the best strategy for managing bone health. Stay as active as you can with weight-bearing exercises and eating a well-balanced diet. If you are on a restrictive diet, make sure it's well-balanced.   [28:12] Dr. Henderson says a lot of our patients have feeding disorders, so they see feeding specialists like Holly. A balanced diet is hard when kids are very selective in their eating habits.   [29:10] Dr. Henderson says calcium and Vitamin D are the first steps in how we treat patients with low bone mineral density. A patient who is struggling with osteoporosis needs to discuss it with their endocrinologist for medications beyond supplementation.   [29:31] Ryan reminds listeners who are patients always to consult with their medical team. Don't go changing anything up just because of what we're talking about here. Ask your care team some good questions.   [29:47] Dr. Henderson would like families to be aware, first, that some patients with EoE will have bone mineral density loss, especially if they are on PPIs and restrictive diets. They should start having those discussions with their providers.   [30:04] Second, Dr. Henderson would like families to be reassured that swallowed steroids and combined steroid exposure didn't have an impact on bone mineral density. Everyone can take that away from today's chat.   [30:18] Lastly, Dr. Henderson gives another plug for patient participation in prospective studies, if they're presented with the opportunity. It's super important to be able to gather more information and make guidelines better for our patients. [30:35] Holly thanks Dr. Henderson for coming on Real Talk — Eosinophilic Diseases and sharing her insights on bone mineral density, and supporting patients in Maine.   [30:57] Dr. Henderson will continue to focus on the clinical side. She loves doing outreach clinics in rural Maine. It's rewarding, getting to meet all of these patients and taking care of patients who would otherwise have to travel hours to see a provider.   [32:01] Ryan thinks the listeners got a lot out of this. For our listeners who would like to learn more about eosinophilic disorders, please visit APFED.org and check out the links in the show notes.   [32:11] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder at APFED.org/specialist.   [32:19] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at APFED.org/connections.   [32:28] Ryan thanks Dr. Henderson for joining us today for this great conversation. Holly also thanks APFED's Education Partners Bristol Myers Squibb, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode: Anna Henderson, MD, a pediatric gastroenterologist at Northern Light Health in Maine Cincinnati Children's “Prevalence and Predictors of Compromised Bone Mineral Density in Pediatric Eosinophilic Esophagitis.” Journal of Pediatric Gastroenterology and Nutrition   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.org/specialist apfed.org/connections   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of Bristol Myers Squibb, Sanofi, Regeneron, and Takeda.   Tweetables:   “DEXA scan stands for dual-energy X-ray absorptiometry scan. It's a type of X-ray where a patient lies down for 10 to 30 minutes. A machine scans over their bones. Typically, we're most interested in the lumbar spine and hip bones.” — Anna Henderson, MD   “We wondered whether or not all of those steroids and those combined risks even put our EoE population at risk for low bone mineral density. There's not a lot published in that area.” — Anna Henderson, MD   “If a patient is worried [about their bone mineral density], their PCP is a perfect place to start for that. They're more than capable of discussing the risk factors specific for that patient, ordering a DEXA scan, and interpreting it if need be.” — Anna Henderson, MD   “I think we need some more prospective studies to look at these risk factors in a little bit more detail than we were able to tease out in our retrospective review.” — Anna Henderson, MD   “Just another plug for the participation in prospective studies, if you're presented with the opportunity. It's super important to be able to gather more information and to be able to make guidelines better for our patients about these risks.” — Anna Henderson, MD

Episode 178 with Estelle Dogbo, systems strategist, healthcare executive, and founder of BioVana Research. Estelle has spent her career at the intersection of biotechnology, digital health, and pharmaceutical development building adaptive health systems across African markets and beyond. From commercial leadership roles at Sanofi and Roche to co-founding 54gene and Syndicate Bio, Estelle has been a quiet force behind Africa's genomics and health data infrastructure.Now, as CEO and Founding Partner of BioVana Research, Estelle is reimagining how African health data is valued, governed, and transformed into powerful R&D assets. BioVana partners with hospitals, universities, and research institutions to bring structure, visibility, and trust to African biobanking ensuring local data is ethically sourced, verifiable, and globally competitive. Their model turns fragmented sample collections into strategic platforms for precision medicine, AI diagnostics, and responsible global collaboration.In this episode, Estelle shares her bold vision for African data sovereignty, why health systems must be built from the inside out, and how BioVana is helping African institutions shift from being invisible custodians to confident stewards of their own scientific future.What We Discuss With EstelleWhy Africa's vast health datasets have remained invisible in global R&D, and how BioVana is changing that through ethical, locally rooted data governance.The critical role of biobanking infrastructure in unlocking breakthroughs in precision medicine, AI diagnostics, and clinical research across the continent.How BioVana is helping African hospitals and research institutions move from passive data custodians to active stewards in the global health ecosystem.What it means to build health systems “from the inside out” and why imported solutions often fail in high-complexity, low-resource environments.The risks of data extraction and decoupling in African research, and how BioVana ensures that local data remains connected to local value.Did you miss my previous episode where I discuss The Future of Fashion Is African: Building an Ethical Clothing Factory in Rural Kenya? Make sure to check it out!Like this show? Please leave us a review here -- even one sentence helps!Connect with Terser:LinkedIn - Terser AdamuInstagram - unlockingafricaTwitter (X) - @TerserAdamuConnect with Estelle:LinkedIn - Estelle Dogbo MSc and BioVana ResearchDo you want to do business in Africa? Explore the vast business opportunities in African markets and increase your success with ETK Group. Connect with us at www.etkgroup.co.uk or reach out via email at info@etkgroup.co.ukSubscribe to our newsletter for exclusive content, behind-the-scenes insights, and bonus material - Unlocking Africa Newsletter

Depuis presque deux mois – le 6 mai 2025 –, Opella France est officiellement passée sous le contrôle du fonds américain CD&R. Sanofi, l'ancien propriétaire, a cédé 50 % de sa filiale santé grand public. Ce changement soulève une question : le Doliprane est-il vraiment devenu américain ?Un premier point important : la production du Doliprane reste française. Malgré le changement de propriétaire, toutes les boîtes vendues en France sont toujours fabriquées à Lisieux (Calvados) et à Compiègne (Oise). La nouvelle patronne d'Opella France, Ségolène de Marsac, a tenu à le rappeler clairement dans une interview à Franceinfo : « La fabrication du Doliprane continue en France, notamment à Lisieux et à Compiègne. »Elle insiste aussi sur l'importance du marché français pour Opella : « La France est notre deuxième plus grand marché », dit-elle. Pour elle, ce rachat est une opportunité de renforcer « notre rayonnement en France », en particulier grâce à des innovations à destination des patients et consommateurs. Et elle affirme que la France reste au cœur de la stratégie d'Opella, avec 1 700 collaborateurs mobilisés et deux sites industriels qui tournent à plein régime.Alors, faut-il s'inquiéter de ce changement de main ? Oui et non. Oui, parce que c'est bien un fonds d'investissement américain – CD&R – qui pilote désormais la société. Mais non, parce que les autorités françaises ont imposé certaines conditions : le maintien de la production sur le territoire et un droit de regard accru. L'État français détient même 2 % du capital et un siège au conseil d'administration. Le ministre de l'Industrie a d'ailleurs rappelé que la France resterait vigilante sur la question de la souveraineté sanitaire.Alors, le Doliprane est-il américain ? Si l'on parle du capital, la réponse est oui. Mais si l'on parle de la production, de l'emploi, ou de l'origine du médicament, la réponse est non. Le Doliprane reste fabriqué en France, par des ouvriers français, sur des lignes françaises. Il est donc, pour l'instant, bien plus français qu'américain.Ségolène de Marsac résume la position d'Opella : continuer à produire en France tout en se réinventant, grâce aux moyens apportés par le nouvel actionnaire. Reste à voir si cette promesse tiendra dans la durée. Hébergé par Acast. Visitez acast.com/privacy pour plus d'informations.

This podcast will discuss an approach to Pityriasis Rosea in children. The podcast was created by Sarah Daraj, a fourth-year medical student at McGill University and Dr. Bailey Komishke, a paediatrician in Calgary. An author of this podcast has an honoraria from L'Oreal, Sanofi and Arcutis for attending educational events, and an honoraria from Arctics, Incyte Solutions and Pierre Fabre for speaking engagement, and also serves on the advisory board for Sanofi.

Since 2019, Pius leads Sanofi China encompassing Greater China, representing the 2nd largest market of Sanofi in the world with over 8,000 associates. Pius and his team are fully dedicated to transforming healthcare by accelerating the introduction and access to innovative and chronic medicines, driving digitalization, as well as empowering people to bring their best to the workplace.Pius' extensive experience in the healthcare industry encompasses a variety of key positions and responsibilities, including leading global core brands, and P&L responsibilities for different geographical areas within Europe, Latin America, emerging markets, and Greater China. He has worked around the world in countries including France, Germany, Switzerland, Turkey, Brazil, Tanzania, and China. He has successfully launched several major innovative medicines both globally and locally.Pius is a native of Switzerland. He started his career in the healthcare industry at the Cardiology Department of the University of Basel in a research collaboration with Novartis in Switzerland, where he earned his PhD in medical research, graduating magna cum laud. He is an alumnus of INSEAD and Singularity University. He speaks fluent German, English, French, and Portuguese.Pius has an extensive experience with various industry associations, where he currently holds several key leadership positions, as an active member of RDPAC Executive Committee and Sponsor of the Market Access Committee, as well as Vice-Chair of the European Chamber Shanghai Chapter. Pius is also speaker at the World Economic Forum's China Chapter.He is a strong believer in the idea that innovation ultimately drives progress and prosperity, an active advocate for increasing diversity in society. Pius is happily married, and a proud father of twin daughters.

Dr. John Sweetenham and Dr. Marc Braunstein highlight top research on hematologic malignancies from the 2025 ASCO Annual Meeting, including abstracts on newly diagnosed chronic phase CML, relapsed B-cell lymphoma, and multiple myeloma. Transcript Dr. John Sweetenham: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. John Sweetenham. On today's episode, we'll be discussing promising advances in newly diagnosed chronic phase CML, relapsed B-cell lymphoma, multiple myeloma, and other hematologic malignancies that were presented at the 2025 ASCO Annual Meeting. Joining me for this discussion is Dr. Marc Braunstein, a hematologist and oncologist at the NYU Perlmutter Cancer Center. Our full disclosures are available in the transcript of this episode.  Marc, there were some great studies in the heme space at this year's Annual Meeting, and it's great to have you back on the podcast to highlight some of these advances. Dr. Marc Braunstein: Yes, I agree, John, and thank you so much for inviting me again. It's great to be here.  Dr. John Sweetenham: Let's start out with Abstract 6501. This was a study that reported on the primary endpoint results of the phase 3B ASC4START trial, which assessed asciminib versus nilotinib in newly diagnosed chronic phase CML. And the primary endpoint of this, as you know, was time to treatment discontinuation because of adverse events. Can you give us your insights into this study? Dr. Marc Braunstein: Absolutely. So, like you mentioned, you know, asciminib is an allosteric inhibitor of the BCR-ABL kinase that has activity in CML, and that includes patients with the T315I mutation that confers resistance to first- and second-generation TKIs. So, the ASC4FIRST study, which was published last year in the New England Journal of Medicine, showed superior efficacy of asciminib compared to investigator-selected first- or second-generation TKIs, actually leading to the FDA approval of asciminib in first-line CML. So, the authors of that study presented data at this year's ASCO meeting from the phase 3 ASC4START comparing safety and time to discontinuation due to adverse events of asciminib versus nilotinib, a second-generation TKI. So, 568 patients with newly diagnosed CML were randomized one-to-one to once-daily asciminib or twice-daily nilotinib. So, at a median follow-up of 9.7 months, about 11% in the asciminib group and 17% in the nilotinib group discontinued treatment, with significantly fewer discontinuations with asciminib due to adverse events. There was also a secondary endpoint of major molecular response, which was also better with asciminib. For example, the MR 4.5, which is a deep response, was 2.5% versus 0.4% favoring asciminib by week 12. So, I think in conclusion, these results build on the ASC4FIRST study, making the case for the superior safety and efficacy of asciminib versus other first- or second-generation TKIs in newly diagnosed CML. Dr. John Sweetenham: Thanks, Marc. Do you think this is going to change practice? Dr. Marc Braunstein: I think so. I think there are still some questions to be answered, such as what resistance mutations occur after first-line treatment with asciminib. But I think the sum of these studies really make the case for using asciminib upfront in CML. Dr. John Sweetenham: Okay, great. Thank you. And let's move on to our second abstract. This was Abstract 7015 and was reported from Mass General Hospital. And this was a study in patients with relapsed and refractory diffuse large B-cell lymphoma and reported the 2-year results of the so-called STARGLO study. This is a comparison of glofitamab, a T-cell engaging bispecific antibody, with gemcitabine and oxaliplatin in this group of patients. Can you tell us a little bit about your impressions of this study? Dr. Marc Braunstein: Absolutely. So just for background, the treatment landscape for relapsed/refractory large B-cell lymphoma is expanding, now with two bispecific antibodies targeting CD20 that are approved after two or more lines of therapy. Among these, glofitamab was approved in 2023 based on phase 2 data showing an objective response rate of 52%, with 39% complete responses in relapsed/refractory large B-cell lymphoma patients after a median of three prior lines of therapy. Distinguishing glofitamab from epcoritamab, the other approved bispecific, glofitamab was given for 12 cycles and then stopped. Additionally, when combined with gemcitabine and oxaliplatin in the phase 3 STARGLO study, there was significantly improved overall survival compared to rituximab plus gemcitabine and oxaliplatin in transplant-ineligible relapsed/refractory large B-cell lymphoma patients at a median follow-up of 11 months.  The authors of that study published last year in Lancet now present at ASCO this year the 2-year follow-up of the STARGLO study. Two hundred and seventy-four patients with a median of one prior line of therapy were randomized two-to-one to glofitamab plus GemOx versus rituximab plus GemOx, with the primary endpoint of overall survival. Here, the median overall survival was not reached versus 13.5 months, with a median PFS also significantly improved at about 14 months versus 4 months in the control. CRS of note in the glofitamab arm was mostly grade 1 or 2, with only about 2.3% grade 3 events. And three of the four patients had grade 1 or 2 neurotoxicity. So, John, putting this into context, I think it's encouraging that we now have randomized data showing the superiority of a bispecific plus chemotherapy over rituximab plus chemotherapy in transplant-ineligible patients. And while only 8% of the patients in the STARGLO study had prior anti-CD19 CAR T-cell therapy, I think this regimen could be considered in those patients who are ineligible for transplant or CAR T-cell therapy. Dr. John Sweetenham: Yeah, I agree. I think a couple of other compelling numbers to me were the fact that around 55% of these patients were alive at 2 years in the group who'd received glofitamab, and that almost 90% of those having that arm of the study who had a CR at the end of treatment were alive at 12 months. So, clearly, it's an active agent and also a kind of great off-the-shelf fixed-duration alternative in these relapsed and refractory patients. Dr. Marc Braunstein: I agree, and I would also note that the phase 3 SKYGLO study is looking at glofitamab plus Pola-R-CHP versus Pola-R-CHP alone. So, we may even be using these eventually in the first-line setting. Dr. John Sweetenham: Absolutely. Let's stay on the theme of diffuse large B-cell lymphoma and look at one other abstract in that space, which was Abstract 7000. This was a study from the HOVON group in the Netherlands, which looked at the prospective validation of end-of-treatment circulating tumor DNA in the context of a national randomized trial. What are your thoughts on this? Dr. Marc Braunstein: So, non-invasive liquid biopsies to detect and monitor cancers via circulating tumor-derived DNA or ctDNA, you know, is really emerging as a valuable tool in both solid and liquid tumors to understand disease biology, and also for drug development. So, to date, the most established application of ctDNA in lymphoma, I would say, is really for monitoring of minimal residual disease. So, in this correlative study by Steven Wang and colleagues in the HOVON group, they evaluated the prognostic significance of MRD status as assessed by ctDNA following first-line treatment with curative intent with either R-CHOP or dose-adjusted R-EPOCH. At the end of treatment, encouragingly, 76% of patients were MRD-negative, and 24% were MRD-positive. Now, of note, MRD-positive status at the end of treatment predicted inferior progression-free survival at 2 years, with only 28% of patients who are MRD-positive being progression-free versus 88% who are MRD-negative. And in fact, all the patients who failed to achieve a complete response after first-line treatment and were MRD-positive ultimately relapsed. So, circulating tumor cells are rarely found in large B-cell lymphomas, and so this study really builds on accumulating data that ctDNA has clinical value to detect residual disease with a non-invasive approach. So, there are many implications of how we could potentially use this to detect early signs of relapse, to potentially escalate treatment for consolidation if patients remain MRD-positive. So, I think this will eventually become utilized in clinical practice. Dr. John Sweetenham: Yeah, I agree. I think it's interesting that it provided an independent assessment of response, which was independent, in fact, of the results of PET-CT scanning and so on, which I think was very interesting to me. And the authors of the abstract actually commented in their presentation that they think this should be integrated as part of the standard response assessment now for patients with large B-cell lymphoma. Would you agree with that? Dr. Marc Braunstein: I would. For one thing, it allows repeated sampling. It's a non-invasive approach; it doesn't necessarily require a bone marrow biopsy, and it may have more sensitivity than conventional response measures. So, I think having a standardized system to assess ctDNA will be helpful, and definitely, I think this will be a valuable biomarker of disease response. Dr. John Sweetenham: Okay, great. Thanks. We're going to change gear again now, and we're going to highlight two abstracts in the multiple myeloma space. The first one of these is Abstract 7507. And this abstract reported on the long-term results of the CARTITUDE study for patients with relapsed and refractory multiple myeloma. What are your comments on this presentation? Dr. Marc Braunstein: So, this study actually got a lot of press, and I've already had multiple patients asking me about CAR T-cells as a result. Just as some background, CAR T-cells targeting BCMA, which is pretty much universally expressed on malignant plasma cells in myeloma, have really shown remarkable responses, especially in heavily pretreated patients, showing superior progression-free survival in both later and earlier phases of the disease, including in randomized studies in patients with second-line or beyond. So, the CARTITUDE-1 was really the original Phase 1/2 study of ciltacabtagene autoleucel, one of the two approved anti-BCMA CAR T-cell products, which was investigated in patients with a median of six to seven prior lines of therapy. So, these were patients who were pretty heavily pretreated. So, in the study presented by Voorhees at this year's ASCO meeting, this was the long-term follow-up at a median of 5 years from the one-time CAR infusion in these patients with a median of five prior lines of therapy. And remarkably, of the 97 patients, 33% remained progression-free at 5 years plus, without needing any further myeloma treatment during that time. And among those 33% of patients, 23% had high-risk cytogenetics, which we know are notoriously difficult to achieve responses in. What was interesting that they presented as correlative studies was there were some biomarkers that were distinguishing the patients who had the long PFS, including enrichment of more naive T-cells in the product, lower neutrophil-to-T-cell ratio, higher hemoglobin and platelets at baseline, and higher CAR T-cell levels relative to soluble BCMA levels. And the fact that they reported a median overall survival of 61 months in these really heavily pretreated patients, I think these data are impressive. I think we're going to continue to be using CAR T even earlier in the disease status than fifth or sixth line, as it was studied in CARTITUDE-1. There are even ongoing studies looking at first-line treatment with CAR T-cells. Dr. John Sweetenham: So, do you think that those 33% of patients who are disease-free at 5 years, do you think any of those are cured?  Dr. Marc Braunstein: That was one of the headlines in the press. I think if we're going to discuss things like "operational cures," where we're transforming myeloma into really a chronic disease, where patients can live practically a normal life expectancy, I think the measure of 5 years, especially in this population that was explored in CARTITUDE-1, I think we can call that close to a cure. Dr. John Sweetenham: Okay. Well, thank you. Exciting data, for sure. We're going to conclude today with another abstract in the multiple myeloma space. And this was Abstract 7500, which looked at an MRD, minimal residual disease-driven strategy following induction and transplant-eligible newly diagnosed multiple myeloma patients and reported on the primary endpoints of the phase 3 MIDAS trial. Can you walk us through this one, Marc? Dr. Marc Braunstein: Absolutely. It is a bit more complicated than the prior one we discussed because this is a randomized study with four arms. So, I'll start by saying that anti-CD38-based quadruplet regimens continue to show superior outcomes in both transplant-eligible and -ineligible newly diagnosed multiple myeloma patients. The MIDAS study mentioned is an open-label phase 3 trial with four arms in transplant-eligible newly diagnosed myeloma patients.  And initially, these patients were all treated with quadruplet therapy with the anti-CD38 antibody isatuximab combined with carfilzomib, lenalidomide, and dexamethasone in 718 newly diagnosed myeloma patients. So, they received the quadruplet regimen for six cycles and then were randomized based on their MRD status at 10 to the negative fifth following six cycles of induction. And that first randomization, if they were MRD-negative, was to either consolidation with six more cycles of the quadruplet regimen or transplant, autologous transplant, plus two cycles additionally of the quadruplet regimen. And both arms were followed by lenalidomide maintenance. The primary endpoint was MRD negativity at 10 to the negative sixth prior to entering the lenalidomide maintenance component. And in addition, the patients who were MRD-positive after induction were randomized to transplant plus two cycles of consolidation or a tandem autologous transplant. So, the median follow-up of the study was about 16 months, and the pre-maintenance rate of MRD negativity was high, between 84 to 86% between the two arms who were MRD-negative, which was not significantly different. And as far as the 233 patients who were MRD-positive, the pre-maintenance MRD negativity was also not significantly different at 40% for those who received autologous transplant, and 32% who received a tandem transplant. So, there's a lot of debate in the myeloma field about the evolving role of autologous transplant and whether transplant still plays a significant role in patients who are either MRD-negative after induction or who have deep remissions and are of standard risk. So, I think these data suggest that patients who are MRD-negative after induction with a quadruplet regimen studied here, which was Isa-KRd, plus consolidation, may possibly be able to forego consolidation with autologous transplant. And likewise, for those patients who are MRD-positive after induction, tandem transplant didn't seem to provide much of a benefit compared to single transplant, which is consistent with prior studies such as the StaMINA study. Dr. John Sweetenham: So, where do you think this leaves us, Marc? Are we going to need more studies before we have any definitive guidance on whether an autologous transplant is still appropriate for those patients who are MRD-negative? Dr. Marc Braunstein: Well, as clinicians, we want to do what's best for our patient. And in myeloma, the best we can do is to get as deep remissions as possible, meaning MRD negativity. And so, I think it's clear from the MIDAS study and others that quadruplet regimens provide the deepest remissions when given upfront. We can debate the role of autologous transplant. I think certainly the role of tandem autologous transplant is fading. But as far as a single autologous transplant as consolidation, I think it's reasonable as a goal to try to achieve MRD negativity after the transplant, especially for patients who remain MRD-positive after induction. Dr. John Sweetenham: Okay, great. Marc, thanks as always for sharing your insights on the heme malignancies studies from the ASCO meeting this year and for joining us on the ASCO Daily News Podcast. Always appreciate hearing your thoughtful and balanced input on these. Dr. Marc Braunstein: My pleasure. Thank you, John. Dr. John Sweetenham: And thank you to our listeners for joining us today. You'll find links to the abstracts discussed today in the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Find out more about today's guest:  Dr. John Sweetenham Dr. Marc Braunstein   @docbraunstein     Follow ASCO on social media:   @ASCO on Twitter  ASCO on Bluesky  ASCO on Facebook   ASCO on LinkedIn     Disclosures:  Dr. John Sweetenham:  Consulting or Advisory Role: EMA Wellness  Dr. Marc Braunstein:  Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb/Celgene, Adaptive Biotechnologies, GlaxoSmithKline, ADC Therapeutics, Janssen Oncology, Abbvie, Guidepoint Global, Epizyme, Sanofi, CTI BioPharma Corp  Speakers' Bureau: Janssen Oncology  Research Funding (Institution): Janssen, Celgene/BMS

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Gilead has received approval for a twice-yearly HIV drug, Lenacapavir, which will be marketed as Yeztugo, potentially redefining the prep market. In other news, biopharma deal premiums show intense negotiations, with Sanofi paying a high premium for Vigil Neuroscience and Novartis acquiring Regulus for $800 million upfront. BioNTech is merging with CureVac after previously criticizing its failed COVID vaccine program. AI is becoming crucial in precision oncology, with companies like AstraZeneca and Pfizer using computational power to design trials and understand challenging cancers better. Intellia Therapeutics aims to transform lives with genome editing treatments.

This episode covers: Cardiology This Week: A concise summary of recent studies Heart disease risk: Framingham Heart Study insights Sudden death in female athletes Mythbusters: Owning a pet reduces the risk of heart disease Host: Susanna Price Guests: Carlos Aguiar, Sabiha Gati, Vasan Ramachandran Want to watch that episode? Go to: https://esc365.escardio.org/event/1809 Want to watch that extended interview on sudden death in athletes? Go to: https://esc365.escardio.org/event/1809?resource=interview   Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. The ESC is not liable for any translated content of this video.The English-language always prevails. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC.   Declarations of interests Stephan Achenbach, Sabiha Gati, Nicolle Kraenkel, Susanna Price and Vasan Ramachandran have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Susanna Price Guest: Sabiha Gati Want to watch that extended interview on LDL management? Go to: https://esc365.escardio.org/event/1809?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/1809   Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors.  This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails.   Declarations of interests Stephan Achenbach, Sabiha Gati, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Ey's 2025 Biotech Beyond Borders report reveals that over one-third of biotech companies have less than a year of cash left, indicating financial challenges within the industry. The report emphasizes the need for a return to basics for biotech companies. Additionally, industry experts are discussing FDA Commissioner Makary's push to modernize the FDA and speed up regulatory processes. Scholar Rock has seen positive results with a weight loss combination therapy, and the FDA's new voucher program has been met with some optimism from biotech investors. Overall, the biotech industry is facing financial struggles, but there are opportunities for growth and innovation in the future.BioNTech and CureVac were once enemies, with BioNTech attacking CureVac's "failed" COVID vaccine program. However, they are now merging, with BioNTech buying CureVac in a $1.25 billion all-stock acquisition. The biopharma industry has seen a string of dramatic deals, with companies paying high premiums for acquisitions. This includes Sanofi paying a 300% premium for Vigil Neuroscience and Novartis acquiring Regulus for $800 million upfront. Overseas biosimilars companies can be sued in the US, potentially dissuading them from targeting the US market and benefiting domestic producers. Lilly's $1.3 billion acquisition of Verve in the gene editing space has been met with skepticism from analysts. Biotechs are seeking partnerships as the industry moves forward, with events like BIO2025 kicking off. The industry is facing challenges such as layoffs at companies like Lycia, while AstraZeneca makes a $5.3 billion AI bet with China's CSPC for chronic disease pills. Overall, the biopharma industry is experiencing a period of intense deal-making and strategic shifts.

Ozlem Goker-Alpan, MD, Founder and President, Lysosomal & Rare Disorders Research & Treatment Center (LDRTC) and Ravi Kamath, MD, PhD, of Fairfax Radiological Consultants & Inova Health System and University of Virginia School of Medicine Fairfax, Virginia, USA discuss best practices to identify and treat bone problems associated with lysosomal disorders.This continuing education activity is provided through collaboration between the Lysosomal and Rare Disorders Research and Treatment Center (LDRTC), CheckRare CE, and AffinityCE. This activity provides continuing education credit for physicians, physician assistants, nurses, nurse practitioners, and genetic counselors. A statement of participation is available to other attendees.This educational program is supported by an educational grant from Takeda and Ultragenyx.To obtain credit, visit https://checkrare.com/learning/p-skeletal-involvement-in-lysosomal-disorders/quizzes/evaluation-skeletal-involvement-in-lysosomal-disorders/ FacultyOzlem Goker-Alpan, MD, Founder and President, Lysosomal & Rare Disorders Research & Treatment Center (LDRTC), Fairfax, VA Ravi Kamath, MD, PhD,Fairfax Radiological Consultants & Inova Health System and the University of Virginia School of Medicine, Fairfax, VirginiaDisclosuresAffinityCE staff, LDRTC staff, CheckRare staff, planners, and reviewers, have no relevant financial interests to disclose. All faculty disclosures are listed below and are included in the beginning of each presentation.Dr. Goker-Alpan is on the Advisory Board/Consultant for Chiesi, Takeda, Sanofi, Prevail/Lilly, Sparks Therapeutics, Uniqure, Exegenesis, Astellas, Freeline, Team Sanfilippo. She receives grants/research support from Chiesi, Sanofi, Takeda, Prevail/Lilly, Spark Therapeutics, Amicus, Freeline, Sangamo, Cyclo, Odorsia, DMT, Homology, Protaliz. She is on the speaker bureau for Sanofi, Takeda, Amicus, ChiesiDr. Kamath is on the Advisory Board for Spur Therapeutics and Intrinsic Therapeutics. He is also a consultant for Sanofi, Shire and Takeda.  Mitigation of Relevant Financial RelationshipsAffinityCE adheres to the ACCME's Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CME activity, including faculty, planners, reviewers, or others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity. A non-conflicted reviewer resolved conflicts of interest for presenting faculty with relevant financial interests through peer review of content.Learning ObjectivesDescribe the role of the orthopedic surgeon in the team approach to careDescribe best practices to monitor bone abnormalities in persons with LDsDescribe best practices to treat bone abnormalities in persons with LDsDescribe research trends in bone abnormalities in persons with LDsPhysiciansThis activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AffinityCE and the LDRTC. AffinityCE is accredited by the ACCME to provide continuing medical education for physicians.AffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.Physician AssistantsThis activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AffinityCE and the LDRTC. AffinityCE is accredited by the ACCME to provide continuing medical education for physicians.AffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Physician Assistants should claim only the credit commensurate with the extent of their participation in the activity.NursesContinuing Nursing Education is provided for this program through the joint providership of AffinityCE and the LDRTC. AffinityCE is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation (ANCC). This activity provides a maximum of 1 hours of continuing nursing education credit. Nurse PractitionersThis activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AffinityCE and the LDRTC. AffinityCE is accredited by the ACCME to provide continuing medical education for physicians.AffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Nurse practitioners should claim only the credit commensurate with the extent of their participation in the activity.Genetic CounselorsCategory 2 CEUThis activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AffinityCE and the LDRTC. AffinityCE is accredited by the ACCME to provide continuing medical education for physicians.AffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credit™. Genetic counselors should claim only the credit commensurate with the extent of their participation in the activity.Other ProfessionalsAll other health care professionals completing this continuing education activity will be issued a statement of participation indicating the number of hours of continuing education credit. This may be used for professional education CE credit. Please consult your accrediting organization or licensing board for their acceptance of this CE activity.Commercial Support Support for this educational activity was provided by Takeda and Ultragenyx. Participation CostsThere is no cost to participate in this activity.CME InquiriesFor all CME policy-related inquiries, please contact us at ce@affinityced.com.Send customer support requests to cds_support+ldrtc@affinityced.com.

Today's guest is Yunke Xiang, Global Head of Data Science for Manufacturing, Supply Chain, and Quality at Sanofi. Yunke joins Emerj Editorial Director Matthew DeMello to discuss the challenges that slow AI adoption in life sciences manufacturing, highlighting how fragmented data systems and legacy infrastructure create hurdles for AI initiatives. In this episode, Yunke explains how years of acquisitions and siloed data have made building a cohesive data foundation difficult, impacting AI's potential in manufacturing and supply chain optimization. Yunke shares Sanofi's approach to balancing build versus buy decisions for AI solutions and the critical role leadership plays in fostering an environment where data science can thrive. Yunke also reflects on the evolving landscape of AI in pharma manufacturing and the importance of strong governance and collaboration for successful implementation. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the ‘AI in Business' podcast! Learn how brands work with Emerj and other Emerj Media options at emerj.com/ad1.

After months of litigation in a federal district court, a key decision recently came out in the legal fight over 340B drug rebates. 340B Health Vice President of Legal and Policy Amanda Nagrotsky updates us on the development.Court deals a blow to drugmakersD.C. district court judge Dabney Friedrich ruled on May 15 that manufacturers cannot unilaterally implement rebate models for 340B, agreeing with the Health Resources & Services Administration (HRSA) that the agency effectively has preapproval authority over rebates. In her decision, the judge cited early results from a 340B Health survey finding that shifting 340B to a rebate model would divert significant hospital resources from patient care. Drugmakers have already appealed the ruling.Some bright spots for drugmakers in this decisionAlthough the decision largely went against pharmaceutical companies, the judge ruled that the 340B statute does not categorically prohibit rebates, leaving the door open for government approvals of rebates. The judge also agreed with drugmakers' assertions that HRSA should consider how rebate models could improve 340B compliance and how requiring the sharing of data through rebates could aid in drug company audits of covered entities.Will HRSA stop all rebates from proceeding?Despite this decision, the legal fight over rebates isn't over yet. The judge found that, for three of the manufacturers in these cases, HRSA has yet to issue final decisions with respect to their proposed rebate models. In the case of Sanofi, the judge found that HRSA failed to adequately explain the legal basis for rejecting the drugmaker's rebate model, and she directed the agency to reconsider its decision and explain whether and how it would violate the 340B statute. HRSA sent rebate guidance to the White House for approval earlier this month, though as of recording this episode it was not known what that guidance would say.ResourcesRead Our Analysis of the First Federal Court Decision on Rebates340B Health Continues Court Fight Against Rebates

Our guest on this week's episode is Brett Wood, Chair this year of the Industrial Truck Association (better known as the ITA). In his daytime job, Brett is the President and CEO of Toyota Material Handling North America. This past Tuesday, the material handling industry recognized the 12th annual National Forklift Safety Day. Sponsored by ITA, the highlight of the day was a series of presentations on safety held at the National Press Club in Washington DC. Wood speaks about the event held this week and the importance and impacts of safety programs.Carriers looking to fill driver positions need to act faster when they identify candidates and ensure that their hiring process is efficient, according to a new report from truck driving technology platform Tenstreet. They found that carriers in their network that responded to driver applications within five minutes see a 6.2% hiring rate, which is nearly double the platform average of 3.7%.—so that speaks to the need for fast action. The Massachusetts Institute of Technology (MIT) has launched a new program called the Initiative for New Manufacturing (INM). The goal is to help transform the nation's industrial base by advancing the future of “new manufacturing,” alongside ideas in workforce training, advanced technologies, and industry collaboration. The initiative includes a group of six founding industry consortium members, who are Amgen, Flex, GE Vernova, PTC, Sanofi, and Siemens. Supply Chain Xchange  also offers a podcast series called Supply Chain in the Fast Lane.  It is co-produced with the Council of Supply Chain Management Professionals. All episodes are available to stream now. Go to your favorite podcast platform to subscribe and to listen to past and future episodes. The podcast is also available at www.thescxchange.com.Articles and resources mentioned in this episode:Industrial Truck AssociationSpeed is critical when hiring truck driversMIT program on new manufacturing adds contract manufacturer FlexVisit Supply Chain XchangeListen to CSCMP and Supply Chain Xchange's Supply Chain in the Fast Lane podcastSend feedback about this podcast to podcast@agilebme.comPodcast is sponsored by: Storage SolutionsOther linksAbout DC VELOCITYSubscribe to DC VELOCITYSign up for our FREE newslettersAdvertise with DC VELOCITY

Episode 053 | Dr. Marthe Dika, MD, FAAD is a board-certified dermatologist and proud owner of M. Dika Dermatology, with practices located in Burlington and Glendale, Wisconsin. At her clinics, she welcomes patients of all ages and skin types, offering comprehensive care for diseases of the skin, hair, and nails. Dr. Dika is particularly experienced in and passionate about managing hair loss and has helped many people who struggle with this often devastating problem.In addition to her clinical work, Dr. Dika is involved in advancing the field ofdermatology through clinical trials conducted at her two locations. Her dedication to research allows her to remain at the forefront of dermatologic advancements and offer her patients cutting edge treatment options.She earned her medical degree from the Medical College of Wisconsin in Milwaukee and completed her residency in dermatology at the University of Iowa. Dr. Dika's commitment to patient care coupled with her passion for dermatology ensures that all who visit M. Dika Dermatology receive the highest quality care tailored to their individual needs.Shout out to Dr. Dika's mentor, Dr. Chesahna Kindred, as mentioned in this episode! Thanks to all the great mentors out there for all that you do. And shout out to the absolutely delightful Whitney Hubbell, PharmD, IBCLC. Dr. Hubbell is currently an all-star Medical Science Liaison at Sanofi, and I'm grateful to her for introducing me to Dr. Dika.This episode was recorded on February 3rd, 2025.Connect with and learn from Dr. DikaM. Dika DermatologyInstagramFacebookMore from Dr. Lewellis and Above & Beyond DermatologyNeed a dermatologist? Fill out this short interest form, text or call me at 715-391-9774, or email me at drlewellis@aboveandbeyondderm.com if you'd like to have a no obligation discovery call. I offer in-office visits, house calls, and virtual care in Wisconsin and virtual care in Illinois, Nebraska, and Colorado.Have an idea for a guest or want to be on the show yourself? Send me a text or email, and we'll see if it's a good fit.Above & Beyond DermatologyNutrafol -- special pricing and physician exclusive productsNeoGenesis -- my favorite source of stem cell released molecules for skin/hairSilagen.biz -- physician dispensed scar refinement products delivered to your door (use practice code 1206240832P)NewsletterLinkedInFacebookDr. Lewellis on InstagramAbove & Beyond Dermatology on InstagramYouTubeTikTokTwitter/XChange Your Mind, Change Your LifeSoMeDocs (Doctors on Social Media)Pippa!

ABD ile Çin, Londra'da iki gün süren müzakerelerin ardından bir çerçeve anlaşması üzerinde uzlaştı. “Halkı kin ve düşmanlığa alenen tahrik etme” suçlamasıyla yargılanan Zafer Partisi Genel Başkanı Ümit Özdağ, ilk duruşmasına çıktı. Bu bölüm Sanofi hakkında reklam içermektedir. Sanofi'nin hayata geçirdiği girişimcilik programı PharmUp'ın 6. dönemini tamamlayan girişimler Vivatech Fuarı'na katıldı. Learn more about your ad choices. Visit megaphone.fm/adchoices

Emmanuel Frenehard, directeur digital chez Sanofi, était l'invité de François Sorel dans Tech & Co, la quotidienne, ce jeudi 12 juin. Il s'est penché sur l'impact digital de la Tech au sein de Sanofi, sur BFM Business. Retrouvez l'émission du lundi au jeud

Giving feedback can be hard. Avoiding it makes things even harder. It's time to do the hard thing and have that feedback conversation. In this episode of Let's Talk, People, Emily sits down with Wanda Shoer, Chief Learning Officer at Sanofi, a global pharmaceutical and healthcare company, to talk about one of the most important, and most avoided, leadership responsibilities: giving feedback.They unpack how to give feedback that's clear, timely, and grounded in growth not fear. From focusing on observable behaviors (not assumptions) to reinforcing belief in a person's ability to improve, the conversation offers practical strategies for making feedback feel like an investment in someone's development. They explore how strong leaders use feedback to unlock potential, not just correct mistakes, and how clarity and specificity can drive accountability without micromanagement.If you've ever avoided a feedback conversation or felt stuck between honesty and empathy, this one's for you.As an added bonus, head to arosegroup.com/resources to grab your complementary guide to having difficult feedback conversations. Timestamps: [00:07:58] – Why Feedback Feels Risky Wanda explores the emotional weight of giving feedback and why fear of embarrassment, shame, or misinterpretation often keeps leaders silent.[00:16:20] – Feedback Is the Job, Not a Bonus Emily and Wanda discuss how giving feedback isn't “extra”, it's core to leading well. When done with clarity and care, it builds trust, ownership, and alignment.[00:25:14] – Focus on Behaviors, Not Labels Why the best feedback avoids assumptions about intent and instead centers on what was observed, experienced, and actionable.[00:35:45] – Growth-Oriented Feedback, Not Fear-Based Wanda shares how to shift the culture of feedback from one of fear to one of possibility, where improvement is expected and supported.[00:44:00] – Unlocking Potential Through Strengths The episode closes with a conversation about leading through strengths, creating clarity, and helping team members feel accountable without micromanagement.Access the episode transcript.Join the Conversation: This year we're taking audience questions! Send in your toughest people management and leadership challenges, and we'll anonymize them and tackle them in an upcoming episode. Email Abigail on our Let's Talk, People team with your situation as a written note or voice memo to abigail@arosegroup.com.Connect with Emily Frieze-Kemeny on LinkedIn and Instagram or explore her work through AROSE Group's website.If you'd like to receive new episodes as they're published, please subscribe to Let's Talk, People in Apple Podcasts, Spotify, or wherever you get your podcasts. If you enjoyed this...

*Hosted by Stéphanie Moles-Rota*In this compelling episode, I interviewed Ruth Beadle, the Head of Supply Chain at Sanofi, where we talked about her transformative leadership journey across various industries and geographies. Ruth shared pivotal moments that shaped her career, the challenges of leading large-scale ERP and AI-driven initiatives, and the human impact behind pharmaceutical logistics. Listeners will gain insights into how Sanofi evolved its supply chain to support innovation, agility, and patient-centered service while navigating change at scale.Discover more details here.Follow us on:Instagram: http://bit.ly/2Wba8v7Twitter: http://bit.ly/2WeulzXLinkedin: http://bit.ly/2w9YSQXFacebook: http://bit.ly/2HtryLd

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Metsera's new long-acting amylin injection, met-233i, has shown promising weight loss results over eight months, leading to a rise in shares. Meanwhile, CDC vaccine advisors are either being pushed out or leaving their positions. Other top stories include Sirna's expansion beyond the liver, Keros returning $375 million to investors, and ACIP members receiving termination notices. In vitro cell research is focused on slowing aging and preventing age-related diseases. Updates on Merck's oral PCSK9 inhibitor, Sanofi and Regeneron's Dupixent effectiveness, and Avidity's muscular dystrophy drug are also highlighted.The expansion of RNA therapeutics is discussed, with multiple companies aiming to target small interfering RNA to various organs by 2030. Uniqure's regulatory progress in developing a gene therapy for Huntington's disease has sparked optimism, although past disappointments for patients are noted. Perspective Therapeutics presents new data on neuroendocrine tumor treatment at ASCO25. Concerns about RFK Jr.'s vaccine campaign and its potential to increase distrust in vaccines are raised in the editorial. Cancer news, cell and gene therapy updates, upcoming events, job listings, and a call for reader suggestions on coverage topics are also covered.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 6 June 2025. In this episode: Sanofi's Blueprint buy; AstraZeneca's breast cancer resistance results at ASCO; BMS and BioNTech's big bispecific deal; Kymera's Dupixent in a pill; and Degron's CEO on pipeline and strategy. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T5ID4HF465BXFGAH7C6OOSEGTA/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Grab your earphones! Get ready to listen and learn!

Dealmaking by a pair of pharmas has given the biotech industry its best day of transactions in months, tallying nearly $13 billion in guaranteed payments across two deals. On the latest BioCentury This Week podcast, BioCentury's analysts discuss how the takeout of Blueprint Medicines for $9.1 billion up front gives Sanofi a drug for a rare immunological disorder and bolsters the French pharma's already strong presence in immunology. The analysts also assess the $3.5 billion partnership between BioNTech and Bristol Myers Squibb for an asset targeting cancer's hottest target, PD-(L)1 x VEGF, and underwhelming data from the leading asset against the target, PD-1 x VEGF bispecific ivonescimab, from Summit and Akeso Inc. Those data coincided with the kick-off of the American Society of Clinical Oncology (ASCO) meeting in Chicago, where almost a dozen companies were presenting readouts for another hot target, CLDN18.2. Evopoint is among the companies; its program recently attracted Astellas as a partner. Meanwhile, the biopharma industry is racing to counter the White House's most favored nation drug pricing strategy. BioCentury's Washington analyst, Steve Usdin, explains the urgency and details some of industry's options.View full story: https://www.biocentury.com/article/656097#biotech #biopharma #pharma #lifescience #deals00:00 - Introduction04:39 - Sanofi Buys Blueprint09:22 - BMS-BioNTech20:01 - Hot Targets23:40 - Drug PricingTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

S&P futures are pointing lower today, down (0.5%). European equity markets are weaker. Asian markets are lower, with Nikkei, Hang Seng and Taiwan underperforming, mainland China closed for public holiday. Overnight, treasury yields went up, with the two year up 2bps and the ten year up 5bps. The U.S. dollar weaker, oil up, gold gains, industrial metals higher. Trade tensions weighing on risk appetite. US-China relations fraying a month with two sides accusing the other of violating Geneva agreement. Main disagreements revolve around US frustration at China slow walking offer of relaxing rare earths curbs and China taking issue with US at new export restrictions. On geopolitical front, China rebuked US after Defense Secretary Hegseth warned of potentially imminent Taiwan invasion. Renewed tensions come as press sources noted efforts underway to set up a Trump-Xi call in bid to move forward talks.Companies Mentioned: Qualcomm, Alphawave IP Group, Sanofi, Blueprint Medicines, BASF

En este episodio cubrimos los eventos más impactantes que están moviendo mercados, tensando relaciones internacionales y transformando industrias clave:

Plus: Costco and Gap see different impacts of tariffs on their businesses. Shares of Ulta Beauty rally after the cosmetics retailer raises its annual outlook. And an experimental lung-disease treatment by Sanofi and Regeneron delivers mixed results. Victoria Craig hosts. Sign up for the WSJ's free What's News newsletter. Learn more about your ad choices. Visit megaphone.fm/adchoices

Today's guest is Shreyas Becker, Head of AI & Data Products, Manufacturing & Supply at Sanofi. Shreyas joins Emerj Managing Editor Matthew DeMello to discuss the practical application of AI in life sciences, focusing on tools that are already improving supply chain resilience and manufacturing efficiency. He explains how AI helps navigate geopolitical disruptions, optimize production workflows, and ensure the reliable delivery of critical medications. The conversation also covers the evolution of AI systems developed during the pandemic and their role in shaping future innovations. For pharma and life sciences professionals, Shreyas provides valuable insights into where AI is delivering impact today and the continuing importance of human expertise in these processes. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the ‘AI in Business' podcast! This episode is sponsored by Arkestro. Learn more about Arkestro's upcoming Advisory Council event here. Find out more about sponsored content and how to engage with the Emerj audience at emerj.com/ad1.