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Play Episode Listen Later Feb 19, 2026 20:51

Dr. Monty Pal and Dr. Ari Rosenberg discuss the evolution of treatment strategies in head and neck cancers, including the challenges of treating both HPV-positive and HPV-negative disease and the emergence of blood-based biomarkers to advance personalized therapy across different subtypes. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist, professor, and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. Today, we're going to explore the evolving landscape of treatment strategies in head and neck cancer management, including locoregionally advanced head and neck squamous cell carcinoma, which happens to be on the rise in United States, in part due to spike in HPV-mediated oropharyngeal cancers. We're also going to discuss the emerging strategies of using blood-based biomarkers to really advance personalized therapy. Joining me for this discussion is Dr. Ari Rosenberg. He's a medical oncologist focused on head and neck cancer, and he's an associate professor – congratulations on the recent promotion – at the University of Chicago. The University of Chicago has really produced luminaries in this field, Dr. Rosenberg included. I've had the pleasure of getting to know Dr. Ezra Cohen over the years, who really had his grounding there, and of course Everett Vokes, former ASCO President. I'm really looking forward to this conversation, Ari. Thanks so much for joining us. Dr. Ari Rosenberg: Thanks, Monty. Thanks for the invitation. Dr. Monty Pal: You got it. And just a quick note for our listeners, our full disclosures are going to be in the transcript at the end of this episode. So let's start with the basics, if you don't mind. So, head and neck cancers are very diverse and they're challenging, right? In the sense that they're near vital organs, the treatments, you know, as we all saw during fellowship, if not now in clinical practice. They can really have such a major impact on vital organ function, speech, swallowing, et cetera. Can you just comment on head and neck cancers that are on the rise in the U.S.? I alluded to this briefly. Particularly, we've heard this in the context of colorectal cancer and so forth. Are you actually seeing younger adults being affected by this? Dr. Ari Rosenberg: Yeah, thanks for that. The vast majority of head and neck cancers are head and neck squamous cell carcinomas, as I'm sure many of the listeners recall as well from fellowship or their current training. And as you alluded to, the organ function, long-term and functional quality of life outcomes are quite important, particularly in the context that these develop in high value real estate, parts of our head and neck area that we use for speaking, swallowing, all sorts of other essential functions as well. As you also alluded to, we think of this in two different particular subtypes of head and neck cancer. The historical head and neck cancer from 50, 60 years ago was almost exclusively related to carcinogen exposure, tobacco, alcohol use, and that subtype of carcinogen-induced head and neck cancer has been slowly declining. However, over the last now several decades, we've been seeing an increase in primary oropharyngeal squamous cell carcinoma, mostly tonsil, base of tongue. These are attributable to HPV, human papillomavirus exposure. And that's now the majority of the head and neck cancers that we tend to see in our clinic. As you also alluded to, these have very different prognoses as well. HPV-related head and neck cancer has a much more favorable prognosis where much of the interest has been in can we de-intensify to optimize long-term function? But then the non-HPV-related head and neck cancer, or what we call HPV-negative head and neck cancer, continue to be very, very challenging. We only managed to cure about half of these folks, with many of these patients developing the current disease. These patients, in addition to being difficult to treat, also have major impacts both in terms of the treatments they undergo as well as their disease that can impact their function and quality of life. And you hinted at this a little bit, but we have been seeing an increase in younger patients with HPV-negative head and neck cancer as well, which is quite concerning. Younger patients, oftentimes never smokers, never drinkers, who are developing non-HPV-negative head and neck cancer. And that's been a little bit of a more recent trend that we've been seeing as well. So, definitely a lot of work to be done to optimize and improve outcomes across all of these different head and neck cancer subtypes. Dr. Monty Pal: I mean, I'm just curious, you know, in the context of colorectal cancer, one of the things that we talk about is the potential role of the microbiome driving some of these young-onset cancers with, you know, perhaps there being an impact on, for instance, inflammation and the gut and what have you. Tell me about head and neck cancer. Is this anything known as to why younger patients might be getting diagnosed with non-HPV type cancers? It's odd to me. Dr. Ari Rosenberg: Yeah, it's a great question. A lot of people are working on it. I think we folks have hypotheses, but it hasn't totally panned out exactly what's going on there. It does have a little bit more of a tendency towards women, whereas historically head and neck cancer is much more common in men than it is in women. But lots of people working on that, whether it's related to chronic inflammation, whether it's related to the microbiome. Whether it's related to dental exposure, dental work. So, a lot of folks trying to parse that out because I agree with you, it needs to be identified alongside improving treatment paradigms for these patients, the young ones and the older patients as well. Dr. Monty Pal: Interesting, interesting. You know, one of the phenomena that was sort of coming around when I was in training 25 years ago was this role of sort of induction therapy for head and neck cancers. And of course, it's really come full circle now to include checkpoint inhibitors and so forth. Tell me a little bit about this and how you apply it, maybe in an HPV-mediated context, maybe in a non-HPV context. Dr. Ari Rosenberg: Yeah, absolutely. Induction chemotherapy, as you alluded to, or neoadjuvant chemotherapy, depending on what the locoregional treatment approach is. Similar to other cancer types where systemic control early on has many potential advantages in this setting. Now, in head and neck cancer, even though induction chemotherapy is quite active in head and neck cancer, both HPV-positive and HPV-negative with pretty good response rates. A survival advantage for all comers with local regionally advanced disease remains unproven. There's been two randomized trials, both underpowered, but essentially did not show a survival advantage, showing that induction chemotherapy for all patients with locoregionally advanced and neck cancer can't be justified for a survival advantage. That being said though, there remains a number of potential advantages of giving induction or neoadjuvant chemotherapy, of course, improving systemic control and debulking the disease early on has potential advantages, and predicting the responsiveness to subsequent radiation treatment. We know for some time in head and neck cancer that the percentage of shrinkage or the response to induction chemotherapy actually predicts outcome related to radiation as a dynamic biomarker where response can be used to select patients, for example, for de-escalated radiation has been an area of active investigation, active research. And it also remains a key opportunity to evaluate predictive biomarkers and understanding pre and post treatment to better understand the biology. I'll just add to your question that recently over this past year, we also saw phase 3 data for neoadjuvant immunotherapy for a subset of head and neck cancer that is surgically resectable. And so that's reintroducing the potential benefit in the immunotherapy era of incorporating immunotherapy in the neoadjuvant or the induction setting as part of the evolving treatment paradigm for these diseases. Dr. Monty Pal: That's really interesting. And you kind of alluded to already several topics that I plan to hit on, you know, for instance, the role of immune checkpoint inhibitors, induction, chemotherapy, and so forth. And you started to touch on biomarkers. And of course, I think that's something near and dear to many of us in academic oncology. One thing that we've started talking a lot about in the context of colorectal cancer is circulating tumor DNA. How do you think this might fit in the context of head and neck cancer? Can you give us a flavor for that? Dr. Ari Rosenberg: Yeah, absolutely. In head and neck cancer, the current landscape is most developed for circulating tumor DNA for HPV-related head and neck cancer. The advantage of HPV-related head neck cancer is that you have a distinctive HPV DNA that does tend to spill out into the peripheral blood and can be detected using various different blood-based assays. And because of that advantage as a tissue agnostic approach, it turns out that a number of HPV DNA plasma assays are actually quite sensitive and quite specific. And a number of them have indeed been commercialized. Of course, not only for detecting a baseline, but also grading responsiveness during treatment and probably most importantly in the post-treatment surveillance setting, the detection of HPV DNA in the plasma remains a very important and substantial predictor of developing recurrent disease. There's been a number of trials that have been emerging looking at ctDNA and HPV-related head and neck cancer, using it, for example, as a strategy to deescalate patients. That was something we saw this past ASCO from the Dana-Farber group, and also using it to early detect recurrence and potentially intervene earlier for patients with minimal residual disease positivity. So, that remains evolving and as many folks are, I think, already using it in the clinic. But ctDNA also has a lot of potential for HPV-negative head and neck cancer. This is actually a bit more challenging to develop because you don't have that HPV DNA that you can track predictably because the tumor is an HPV- negative disease are much more heterogeneous, but there are a number of data that are coming out both for personalized assays such as Signatera or some of the other assays that require tumor. Unlike colon cancer, which you referenced, where most patients get surgery upfront, in head and neck cancer, many of the patients receive non-surgical pre-chemoradiation. So sometimes the amount of tumor available to generate a personalized assay is more limited and can be one of the challenges that we see in head neck cancer. But certainly that also seems to be emerging. And there's also further assays that are being developed for HPV-negative head neck cancers, such as methylomic signatures and others that may be tissue informed or tissue agnostic. And these are also emerging, particularly in the post-treatment surveillance setting as strong predictors of recurrent disease. So while we're certainly behind some of these other more common tumor types, colon cancer, lung cancer, we're right there with them and more and more trials are going report out, including a number of trials in our upcoming [University of Chicago] Head and Neck Cancer Symposium where I'll be presenting some data and others in the field will be presenting some data looking at ctDNA both for HPV-positive and for HPV- negative to try to improve outcomes for these patients. Dr. Monty Pal: That's so interesting. I've got to tell you that in kidney cancer, what I deal with day to day is a very low shedding disease, right? So techniques as opposed to ctDNA looking for tumor-informed information, that might be less preferred to something like methylomics where you might not necessarily be so contingent on what's happening in the primary tumor. I'm really interested in you mentioning that. Just a point of clarification, this is something I'm trying to wrap my head around. You'd mentioned circulating tumor HPV DNA, right? I assume this is markedly different from just looking for HPV titers in the patient, right? So is this actually incorporated elements of HPV within, you know, essentially host genome, if you will? Dr. Ari Rosenberg: Yeah, correct. This is circulating tumor HPV DNA. And we think of it biologically as a plasma-based tumor DNA biomarker that's specific for HPV-related head and neck cancers. Dr. Monty Pal: Got it, got it. It makes me wonder whether or not this might be applicable to diseases like cervical cancer and so forth where there's also extensively, you know, biology driven by HPV. Is that fair? Dr. Ari Rosenberg: Yes, definitely. And in the head and neck cancer field, much of this ctDNA actually was derived from a different viral mediated head neck cancer, is less common in the U.S., but nasopharyngeal cancer, which is oftentimes associated with EBV. That has been a biomarker for quite some time in nasopharyngeal cancer. Of course, in places where EBV-associated nasopharyngeal cancer, is endemic, such as East Asia, this has been around for quite some time, but we've been using that in the U.S., and there's been trials that have used EBV DNA plasma to predict recurrence and stratify for adjuvant treatment, for example. And so now with HPV, it's much more applicable to our US population because the vast majority of our head and neck cancer patients that we see in the US that are viral mediated in the US tend to be HPV-related. So having assays that we can use to improve outcomes for that biological subset remains of particular interest for us. Dr. Monty Pal: Yeah, that's fascinating. By the way, for the fellows listening, there's tons of boards pearls here that Dr. Rosenberg shared, EBV-associated cancers, the role of HPV and treatment association. So if you're recertifying anytime soon, I definitely think there's notes to take from this conversation indeed. I wanted to shift gears a little bit. And obviously, you're a prolific researcher. I don't think anyone goes through their fellowship in medical oncology without recounting these experiences of our head and neck patients really suffering from treatment-related toxicities. It's a real challenge. And I'm just wondering, I know a big body of work that you're focused on is really using multimodality treatment paradigms to perhaps reduce the cumulative treatment burden of patients with head and neck cancers. Can you talk about that a little bit? Dr. Ari Rosenberg: Yeah, definitely. Thanks for the question. And before I start going into some of the strategies, I'll just say that head and neck cancer, this is particularly for the fellows that are listening as well, just in reference to your prior comment, that this is really a multidisciplinary disease. At our center, all head and neck cancer patients are seen upfront at that first visit by all three specialties, med onc, rad onc, and surgery, because the choice and sequencing of modalities to optimize not only survival, but also functional quality of life outcome is so critical. And I think that's probably the biggest takeaway for anyone who treats a lot of head and neck cancer or will be treating a lot of head and neck cancer in the clinic. But in terms of more specific attempts at trying to optimize some of those parameters that you described, we really think about these separately in terms of HPV-positive and HPV-negative head and neck cancer. For HPV-positive head and neck cancer, the cure rates are quite high with chemo radiation, although not for everyone. There's still about 15, 10 to 15 % of folks that will develop a recurrence. But for the vast majority of patients, standard chemoradiation is quite a cure to therapy, but the toxicity associated with that can be quite substantial. And so there's been a number of attempts to try to deescalate treatment. It turns out that deescalating everyone with locoregionally advanced HPV-positive head and neck cancer is not a good strategy because it's not able to select out the patients that really do need full dose treatment. And we have seen some negative trials that show inferior outcomes when everyone is deescalated. But what does remain promising is again, trying to select out who the best candidates are for deescalated treatment. The folks at MSK have hypoxia imaging that they're using in trials that looks quite promising to select for the more favorable deescalatable biology. At our center, we've been interested in using induction chemotherapy to stratify response and select patients for deescalated treatment with excellent survival outcomes and reduce toxicity with deescalated treatment. And more recently, ctDNA that us and other groups, such as the Dana-Farber group, is using. And that also looks quite promising. Again, how do you select the patient who will do well with less radiation versus the ones that really need the full doses and volumes of radiation? And then for HPV-negative head and neck cancer, this is a much trickier disease because already the survival outcomes are not like we want it to be. Trying to figure out how to improve survival outcomes remains an important thing. Using immunotherapy seems to be one of the key cornerstones to that. But these are patients that also suffer from a lot of toxicity related to their treatment. We completed a trial not too long ago that we published this past year where we, in HPV-negative head and neck cancer patients, de-intensified the radiation for responders to neoadjuvant chemoimmunotherapy. And those patients did similar, if not even a little bit better, than the non-responders who got full dose treatment. So something that does warrant further investigation as well. How do we not only improve survival for those patients, but also reduce some of the long-term toxicities? Dr. Monty Pal: This is brilliant. I'm taking so many notes as you were mentioning these items. There are so many areas where I think the research crosses over. I already mentioned, know, ctDNA, for instance, and metabolomics and the places where that might apply to kidney cancer. The hypoxia imaging really caught my ear too. Obviously, kidney cancer is disease highly predicated on hypoxia. So thank you for all of this. We've got about a minute or so. So, I'm going to ask you for a really tall task here. Can you tell us what you foresee being some of the biggest challenges that sort of lie ahead and head and neck cancer. You've already kind of alluded to it with ongoing research, but if you had to pick maybe 2, 3 problems, the very most that we really need to get to and head and neck cancer, what would that be? Dr. Ari Rosenberg: Yeah, that's a great question. Obviously, lots of things to be done, but if I'm going to limit it to just a couple, I would say number one is really trying to improve the survival for HPV negative local regionally advanced head and neck cancer. We talked early on about how we are seeing, you know, of course we see many of these people that were smokers and drinkers, but also seeing these in younger patients, in patients without a history of tobacco use. Some of these are very biologically aggressive and we need better treatments beyond surgery, beyond chemo radiation, beyond immunotherapy to improve outcomes for these patients and cure more of them. So, I would say that's one big area. And the other is, which we didn't speak about so much in this talk, but remains one of the biggest challenges that we see in the clinic is the recurrent metastatic head and neck cancer patients. This is an incredibly challenging disease to treat, not only with poor survival, but also with substantial impacts on quality of life and function. mean, these are bad recurrences that cause a lot of pain, functional deficits, really impacts quality of life as well. So developing novel therapies, many of which are currently in clinical trials and many of which are currently continuing to be developed, remains so critical. How do we develop better systemic therapies, better targeted therapies, better biomarkers for recurrent metastatic head neck cancer to improve their survival and quality of life and functional outcomes. Those are the two big areas that require the most work at this time within the head and neck cancer field. Dr. Monty Pal: That's brilliant. I mean, I have to tell you I could probably talk to you all day about this, such a fascinating topic. It's a very exciting time in the field. Thank you, Dr. Rosenberg, for all your incredible contributions and thanks for sharing with us your insights on the ASCO Daily News Podcast. Dr. Ari Rosenberg: Yeah, and thanks for the introduction. Hope to do it again soon. Dr. Monty Pal: And many thanks to our listeners for your time today. If you value the insights that you hear from the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. More on today's speakers:     Dr. Monty Pal  @montypal Dr. Ari Rosenberg @AriRosenbergMD Follow ASCO on social media:          ASCO on X    ASCO on Bluesky         ASCO on Facebook          ASCO on LinkedIn          Disclosures:       Dr. Monty Pal:      Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview     Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical     Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis  Dr. Ari Rosenberg:     Stock and Other Ownership Interests: Privo Technologies Consulting or Advisory Role: Nanobiotix, EMD Serono, Vaccitech, Novartis, Eisai, Astellas Pharma, Regeneron, RAPT Therapeutics, Geovax Labs, Janssen, Summit Therapeutics Speakers' Bureau: Coherus Biosciences Research Funding (Inst.): Hookipa Biotech, EMD Serono, Purple Biotech, Bristol-Myers Squibb/Celgene, BeiGene, Abbvie, Astellas Pharma, Pfizer, Janux Therapeutics

united states university chicago los angeles dna cancer treatments pfizer similar younger monty rosenberg hpv merck east asia janssen novartis accommodations personalizing asco genentech abbvie msk regeneron ebv ipsen dana farber head and neck eisai ctdna emd serono ezra cohen crispr therapeutics osel hpv dna transcript dr everett vokes

Biotech Breakthroughs: AI, CAR-T, and Clinical Trials

Play Episode Listen Later Feb 10, 2026 7:18

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a range of stories that highlight the dynamic and often challenging landscape of these industries, as they navigate through scientific breakthroughs, strategic collaborations, regulatory hurdles, and market trends.Starting with corporate restructuring, Roche's Genentech has announced significant layoffs, totaling 489 positions in the previous year. This move is part of broader restructuring efforts seen across large pharmaceutical companies like Bayer and Bristol Myers Squibb. The layoffs illustrate the tightening financial and scientific constraints that are influencing pipeline decisions and capital allocation. Companies are facing increasing pressures to maintain credibility while also dealing with economic challenges that impact their strategic directions.On the regulatory front, the U.S. Department of Health and Human Services (HHS) encountered legal setbacks concerning its 340B rebate model pilot program. Following a lawsuit from the American Hospital Association, HHS withdrew notices and application approvals for this initiative. This development indicates a need for more comprehensive public feedback before any future attempts at similar programs are made, highlighting how complex regulatory landscapes can become.Turning to clinical trials, Fierce Biotech identified several significant failures in 2025, underscoring the inherent risks involved in drug development. These setbacks emphasize the importance of robust trial designs and execution strategies to mitigate risks. Meanwhile, Fresenius Kabi and Phlow Corporation have announced a strategic alliance to produce epinephrine injection API in the U.S., aiming to strengthen supply chain resilience—a crucial lesson learned from vulnerabilities exposed during the COVID-19 pandemic.Eli Lilly has made waves with its $2.4 billion acquisition of Orna Therapeutics, marking its entry into the in vivo CAR-T space. This acquisition underscores a growing interest in advanced cell therapies with transformative potential for cancer treatment. Additionally, Lilly has expanded its collaboration with Innovent Biologics through a $350 million upfront payment and milestone payments totaling $8.8 billion, focusing on oncology and immunology. This reflects a shift towards deeper integration in drug development efforts beyond traditional licensing models.Takeda Pharmaceuticals' $1.7 billion AI-driven drug discovery agreement with Iambic Therapeutics highlights the increasing adoption of artificial intelligence to accelerate drug discovery processes. AI's potential to enhance precision medicine approaches is becoming more pronounced as companies seek innovative methods to improve target identification and lead optimization.In market dynamics, Hims & Hers withdrew from launching a generic version of Novo Nordisk's weight loss pill due to regulatory pressures from the FDA. This incident underscores the complex interplay between innovation and compliance that companies must navigate when bringing new therapeutics to market. Additionally, legal actions have been initiated by Novo Nordisk against Hims & Hers over patent infringement claims related to semaglutide—a case highlighting ongoing challenges in patent protection within rapidly evolving drug compounding arenas.Eli Lilly also leveraged the global stage of the Winter Olympics for a campaign drawing parallels between scientific progress and athletic achievement. Such campaigns align with industry efforts to enhance public perception and trust amid ongoing challenges.Overall, while the pharmaceutical and biotech industries face significant challenges—from regulatory hurdles to clinical trial setbacks—there are substantial opportunities for growth driven by technological advancements and strategic collaborations. NaSupport the show

Can Low-Dose Immunotherapy Expand Global Access to Cancer Care?

Smart Biotech Scientist | Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists

Play Episode Listen Later Feb 5, 2026 14:53

Dr. Monty Pal and Dr. Atul Batra discuss the PLANeT study from India, which evaluated low-dose pembrolizumab in addition to neoadjuvant chemotherapy for triple-negative breast cancer, and its place among a growing body of international research on improving efficacy while reducing costs and toxicity with lower doses of immunotherapy. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist, professor, and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center, Los Angeles. My guest today, I think, is going to be a really riveting one. It's Dr. Atul Batra, who is an additional professor of medical oncology at the All India Institute of Medical Sciences, or AIIMS, in New Delhi. And he's also the senior author of the PLANeT study. It's a very compelling study that evaluated low-dose pembrolizumab in addition to neoadjuvant chemotherapy for triple-negative breast cancer. And it's really a big part of a growing body of research that's showing balanced efficacy when we use lower doses of immunotherapy instead of standard doses to reduce cost, as well as potentially toxicity. I think this has huge implications for our global audience, and I'm so thrilled to have you on the podcast today, Dr. Atul Batra, welcome. Dr. Atul Batra: Thank you, Dr. Pal. Dr. Monty Pal: And we'll just take it with first names from here since we're both friends. I have to give the audience some context. Atul, I had the great honor of visiting AIIMS New Delhi. For those that don't know, this is really, you know, the Harvard Medical School of India. It's the most competitive institution for medical training. And on the back end of that, there's also incredible resources when it comes to clinical trials and infrastructure. I just wanted to have you give the audience sort of a scope of the types of trials that you've been able to do at AIIMS New Delhi. Dr. Atul Batra: Thank you, Monty. So, I work at the All India Institute of Medical Sciences, and we had the honor and pleasure of having Monty here this month. And people are still in awe of his lectures that he delivered there. Coming back to our institute, so it's kind of a medical college. It's one of the oldest ones, it was built in 1956. We are lucky enough that we get the best of the residents and fellows because they have to go through an exam, a competitive exam, and mostly it's them who come to us and we're able to do some good work out here. Regarding the trials that we have conducted, we do conduct some investigator-initiated studies, and we try to answer the questions where we can help our own patients. Like, for example, this PLANeT study. Every other patient in the clinic was almost not able to afford Keytruda at the full dose, pembrolizumab, and we had a lot of evidence creeping in that a lower dose might be helpful. And that's how we planned this study. Before that, there are certain cancers that are peculiar to India, like gallbladder cancer, head and neck cancers. These are much more common in India as compared to the U.S., and there are some good studies that have been conducted from our own institute by our senior colleagues which have been presented at ASCO and published in the JCO. We also did the capecitabine hand-foot syndrome study that was known as the D-ToRCH study: 1% diclofenac gel that became the standard of care to prevent hand-foot syndrome. So, that's kind of a brief overview of investigator-initiated studies. India is slowly and steadily becoming a partner of the global registration trials. And it's more recently, the last five years or so, we have seen that the number of phase 2 and phase 3 trials are increasing and we are able to offer now these trials as well to our patients. Dr. Monty Pal: That was a terrific overview. I just want to highlight for the audience, as we go through some of your discussions today around specific trials, the speed at which this can be done. Just for context, for me to accrue a clinical trial of 30 patients – I think many people have probably come across some of the work that I've done in the microbiome space – at a single institution, 30 patients, right, takes me about a year and a half, two years. We're going to go through some trials today where Dr. Batra and his team have actually, in fact, accrued close to 200 patients over a span of just a year, which is just remarkable by, I would say, any American standard. So, I see a real need for partnership and Atul, I'll kind of get back to that at the end. But without further ado, the focus of this podcast today, I think, is really this terrific presentation you gave in an oral session at ESMO and subsequently published in Annals of Oncology related to the PLANeT study. Would you give the listeners some context around what the study entailed and population and so forth? Dr. Atul Batra: So, we know the KEYNOTE-522 became the standard of care for triple-negative breast cancer, where Keytruda, when added at 200 mg, the standard dose every three weeks with neoadjuvant, increases the pCR from around 51% to 64% by a magnitude of around 13%. However, in India and other low-middle income countries, less than 5% of the patients actually have access to this dose of pembrolizumab. So, our standard of care was actually just chemotherapy till now. And this kind of led us to design this trial. There are data that come from previous trials conducted in India, from the Tata Memorial, done in head and neck space, some other studies done in Hodgkin's lymphoma, that a much lower dose, probably around one-tenth of the dose, works well in these cancers. So, that's where we designed the PLANeT study, where we gave the standard neoadjuvant chemotherapy in the control arm, and in the experimental arm we added 50 mg of pembrolizumab. This was given every six weeks for three doses. So, that's a total of 150 mg over the neoadjuvant period as compared to 1,600 mg that was given in the KEYNOTE-522 study. So, this was almost one-tenth of the study. Dr. Monty Pal: So, a tenth of the dose, which is just remarkable. I mean, that's just such an interesting concept. Dr. Atul Batra: And the results, when we – the primary outcome, this was a phase 2 study. We just wanted to see, is there a signal of activity? And to even our surprise, when we looked at the pathological complete response rates, in the control arm this was 40.5%, and in the experimental arm this was 53.8%. So, a difference came to around 13.3%; it was numerically, I mean, so much similar to what KEYNOTE-522 had with just these many doses. So, this was around 160 patients randomized over one year. We could randomize them in one year because of the load that we see. And the primary endpoint was met, and we could see that the path complete response did show a remarkable increase. We are still following these patients to see whether there is a difference in event-free survival at a longer follow-up. Until now, it's a small follow-up, so the number of events absolute, are different: four events in the experimental arm and 11 events in the control arm. So, we are seeing some signal even in this much short follow-up period as well. But we need to see more of what happens in the longer term. Dr. Monty Pal: That's so impressive. I wonder, with this lower dose, do you attenuate toxicity at all as far as you can gather? Dr. Atul Batra: So, although we shouldn't be doing kind of cross-trial comparisons, but if you look at thyroid dysfunction, we saw that around 10% of our patients had this thyroid dysfunction. This was compared to 15% in the KEYNOTE-522, that was a larger sample size though. But we're seeing that all the toxicities are somewhat less as compared to those in the standard dose. So, the exposure is less, but I mean, I can't really commit definitely on this. For this we would need much more data to say this with more confidence. Dr. Monty Pal: Yeah. I'm going to ask you a really tough question to follow up, and this is probably something that's on everyone's mind after reading a study like this. Is this something that is disease-specific that needs to be replicated across other histologies? The reason I ask this is, you know, you think about paradigms like, for instance, in the States we're toying between intravenous versus subcutaneous delivery of checkpoint inhibitors, and we have studies focused in specific histologies that might justify use across all histologies. With this particular phenomenon, do you think we need to do dedicated studies in renal cell or in colon cancer and other places where, you know, in selected settings we might use checkpoint inhibitors and then decide whether or not there's this dose equivalence, if you will? Dr. Atul Batra: That's a real tough one, though. But I'm happy to share that there are several ongoing studies within India currently. At our institute, my colleagues are leading studies in lung cancer space, cervical cancer. There was already a publication from Tata Memorial Hospital in head and neck cancers and we see that the signal has been consistent throughout. Regarding renal cancer, there was one study that was presented for sure at ASCO from CMC Vellore, that's again a center in South India. That was in RCC at a much lower dose. And for patients who cannot take the full dose, we actually are offering lower dose nivolumab in such patients and we are seeing responses. I mean, we haven't done those randomized trials again because the numbers are much lower in kidney cancers, we know. We could do this trial in triple-negative ones because we had support and we had numbers to conduct this trial. But I'm sure this should be a class effect. I mean, when we can get tumor-agnostic approvals, then some real-world data has come up in almost all tumors, we have seen that consistent effect across tumors. And as we speak of today, I'm also delighted to share that in India, yesterday, we had the first biosimilar of nivolumab and that's now available at a much, much lower price than the original patent product. There was a long ongoing lawsuit that was there, that's over now, and from yesterday onwards, I'm so happy to share here that we would have the first biosimilar of nivolumab that's available. That's going to bring the cost to almost like one-tenth already. Dr. Monty Pal: Wow. That's huge. I'm going to be very selfish here for a second and focus on a study that is in the renal cell space that your group has done. You know, when it came out, I was really sort of intrigued by this study as well and it reflects sort of a different capability, I think, of AIIMS New Delhi, and that's in the, what I'm going to call, biomarker space. This, for the audience, was a prospective effort to characterize germline variants in patients with advanced kidney cancer. And it's something that we talk about a lot in the kidney cancer literature, whether or not we're missing a lot of these so-called hereditary patterns of RCC. Can you tell us a little bit about that study too? Dr. Atul Batra: Yeah, so that was led by one of our fellows, Chitrakshi Nagpal, and she's just completed her fellowship. And two years back we published that. So, that was done in almost 160 consecutive patients that we recruited over the span of just one year and we saw, apart from the common known mutations in RCC, that was around 5% or so, but a lot of other mutations were also seen that we don't generally see in kidney cancers and we see in other cancers like BRCA1, BRCA2 and others. We are still, I mean, doing those analyses to see whether we get more things out of there in the somatic: is there a loss of heterozygosity or was it just present and in there? Dr. Monty Pal: I thought it was a terrific study and again, I was just so blown away at the pace. I mean, as I look at 140 patients accrued over a span of one year, this is something that would take us perhaps three times as long at City of Hope, and that's with a very sort of, what I consider to be large and dedicated kidney cancer program. So, it really underscores, I think, the need for collaboration. And ever since I came back from my visit to you at AIIMS Delhi, I think I've just been sort of transformed in the sense of trying to think of better ways for us to collaborate. One tangible thing that I'm going to get cracking on is seeing whether or not perhaps we can form some partnerships through SWOG or what we call the NCTN, the National Clinical Trials Network here within the U.S. Talk to me about collaboration. I mean, you've been really terrific at this. How do you sort of envision collaboration enhancing the global landscape of oncology? Dr. Atul Batra: That's really amazing, Monty. That's what we need. We have the infrastructure, we have the manpower, we have patients. I mean, these are all high-volume centers. Unfortunately, we are a little less in numbers, so we are more clinically occupied as well. So, sometimes it's kind of tougher, but again, when it comes to helping out the patients, global collaboration, we need to kind of take you guys along with us and have our patients finish trials earlier. This is a win-win situation for patients, one, because they also get exposure or an option to participate in the clinical trials, and second, we can answer all these scientific questions that we have at a much faster pace. All those things can be done within a much shorter span of time for sure. We are so happy to hear that, and with open hands we are ready to collaborate for all these efforts. Dr. Monty Pal: That's awesome. You know, I came back thinking, gosh, this would be so ideal for some of these rare subtypes of kidney cancer. Prospective clinical trials that I'm running in that space where really we're threatened with closure all the time. And if we just sort of extended a hand to, you know, our partners in India and other countries, you know, I'm sure we could get this research done in a meaningful way and that's got to be a win for patients. Atul, I had such a terrific time chatting with you today. I'm looking forward to seeing lots more productivity from your group there. By the way, for our viewership here, take a look and see what AIIMS New Delhi is doing under the leadership of Dr. Batra and others. It is just a real powerhouse and I think that after doing so, you'll be enticed to collaborate as well. I'm hoping this is the first of many times that we have you on the podcast. Thank you so much for joining. Dr. Atul Batra: Thank you so much for having me here, Monty. It was a pleasure as always speaking to you. And thank you again. Dr. Monty Pal: You got it. Well, and thanks to our listeners. I encourage you to check out Dr. Batra's paper. We'll actually have a link to the study in the transcript of this episode. Finally, if you value the insights that you heard today on the ASCO Daily News Podcast, please 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. Monty Pal  @montypal Dr. Atul Batra @batraatulonc Follow ASCO on social media:         ASCO on X   ASCO on Bluesky        ASCO on Facebook         ASCO on LinkedIn         Disclosures:      Dr. Monty Pal:     Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis    Dr. Atul Batra: Stock and Other Ownership Interests: Zydus Pharmaceuticals, Glenmark, Caplin Point Laboratories, Laurus Research Funding: AstraZeneca, Astellas Pharma, Alkem Laboratories

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224: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang - Part 2

Play Episode Listen Later Jan 29, 2026 16:40

The cultivated meat industry has captured headlines and struggled with economics. Meanwhile, plant cell biomanufacturing is quietly solving the cost equation and approaching commercial launch. The question isn't whether cellular agriculture can work at scale. It's which applications will get there first, and what bioprocessing innovations will make it possible.In Part 2, we dive into the commercialization challenges that separate laboratory curiosity from market-ready products. Steven Lang tackles the hard questions: How do you replicate chocolate's complex flavor profile without traditional fermentation? What analytical infrastructure ensures product consistency and safety? And how do you build the right team and data foundation to navigate the journey from premium launch to commodity-scale production?Steven's background spanning Johnson & Johnson, Genentech, and Upside Foods gives him a unique perspective on what works and what doesn't when translating biopharma rigor to food applications. At California Cultured, he's applying those lessons to launch high-flavanol cocoa powder in 2026, with a clear roadmap to commodity cocoa and coffee thereafter.In this episode:The challenge of replicating chocolate's taste and fermentation in the lab (02:39)How plant cell culture differs from conventional farming and its advantages for safety and scalability (03:03)Analytical methods and equipment needed for consistent, safe, and high-quality cultured cocoa products (05:05)The potential for cell-based food to minimize heavy metals and other contaminants in chocolate (06:09)Environmental implications: tackling climate change, deforestation, and the realistic timeline for widespread adoption of lab-grown foods (06:50)Emerging opportunities beyond cocoa and coffee—saffron, ginseng, echinacea, and even lab-grown wood (08:40)Key advice for scientists and entrepreneurs interested in entering the cellular agriculture field (10:12)Building successful teams and robust data foundations in biotech startups (11:43)Key takeaway:Cellular agriculture's future isn't a single technology replacing conventional food production. It's multiple parallel approaches creating resilience in global food systems. The opportunity is clear: the technical principles you've mastered in biopharma translate directly to food applications, but the faster commercialization timelines and novel business models require rethinking what "stage-appropriate development" means.The question for bioprocess leaders is whether you'll help build the solutions to bridge the food production gap, or watch from the sidelines as food security becomes the defining challenge of our generation.Here is the previous conversation with Steven Lang:Episodes 55-56: Cultivated Meat: A Promising Future or an Inevitable Bubble? with Steven LangConnect with Steven Lang:LinkedIn: www.linkedin.com/in/steven-lang-b003406California Cultured Inc.: www.cacultured.comNext step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

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223: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang - Part 1

Smart Biotech Scientist | Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists

Play Episode Listen Later Jan 27, 2026 27:50

What if the chocolate industry's reliance on equatorial farms—and the deforestation that comes with it—could be eliminated entirely? Plant cell bioreactors are doing that, producing real cacao without a single tree. But this isn't just about chocolate. It's about fundamentally rethinking how we manufacture food at scale, and the bioprocessing innovations emerging from this shift have implications far beyond the food industry.Steven Lang, Head of R&D at California Cultured, spent two decades mastering mammalian cell culture at biopharma giants like Johnson & Johnson and Genentech. Then he made a radical pivot: applying those same bioprocessing principles to cultivate plant cells for food production. His mission? Prove that cellular agriculture extends far beyond the cultivated meat narrative, and that plant cell manufacturing offers a faster, more economical path to market.At California Cultured, Steven's team is scaling cacao and coffee production using innovative low-cost plastic bioreactors instead of expensive stainless steel vessels. They've engineered plant cell media formulations that operate at a fraction of typical bioprocessing costs. And they're preparing to launch their first commercial product—high-flavanol cocoa powder—in 2026.What you'll discover in this episode:Why cellular agriculture ≠ cultivated meat (07:16) – Steven's frustration with the narrow definition that's holding the industry back, and why plant cell culture deserves equal attentionPlant vs. animal cell culture fundamentals (09:26) – Technical comparison: totipotent plant cells, callus formation, adaptation to suspension culture, and how cacao cell lines are developed from explantsAchieving 30-40% pack cell volume in 7-day batches (11:14) – Process parameters: ambient temperature growth, low pH environments, minimal downstream processing, and maintaining product consistency without genetic modificationThe economics that change everything (14:38) – How plant cell media costs and simple raw material requirements create commodity-scale economicsThe Tesla model for biotech (15:58) – Strategic rationale for launching with premium high-flavanol cocoa powder first, then using that revenue runway to optimize for commodity pricingLow-cost bioreactor innovation (18:23) – Why plastic vessels beat stainless steel, contamination management in low-pH cultures, and scale-out strategy over traditional scale-upDecentralized biomanufacturing (23:10) – Converting underutilized office space into production facilities, onshoring food ingredient production, and what this means for emerging markets and supply chain resilienceThe bigger picture beyond cacao (24:23) – Four approved drugs already produced via plant cell culture, the expanding landscape of ingredients (saffron, ginseng, echinacea), and why stage-appropriate models matter for cellular agriculture's futureThe strategic insight:While the cultivated meat industry struggles with cost structures and consumer acceptance, plant cell manufacturing is quietly proving the business model. The lesson for bioprocessing professionals? Sometimes the fastest path to commercialization isn't the most obvious one, and the innovations happening in food manufacturing today could reshape how we think about bioproduction economics across industries.Here is the previous conversation with Steven Lang:Episodes 55-56: Cultivated Meat: A Promising Future or an Inevitable Bubble? with Steven LangConnect One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.Support the show

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WIL Talk #208: Your body knows before your resume does.

WIL Talk (Women in Leadership Talk)

Play Episode Listen Later Jan 23, 2026 35:50

What if your body already knows when it's time to lead differently before your mind catches up?In this powerful episode of Women in Leadership Talk, Vicki Bradley sits down with physician, biotech executive, and author Sheila Gujrathi to explore the journey from medicine to the boardroom and what it really takes to lead with impact, alignment, and self-trust.Sheila shares how listening to her inner voice (and physical cues) led her from clinical practice to McKinsey, Genentech, and ultimately biotech leadership. Together, they unpack why self-care is not selfish, how chronic stress shows up in women's bodies, and why leadership starts with nervous system regulation and self-awareness.Want to deepen your leadership journey?You'll find two FREE mini-courses designed to elevate your leadership skills and a powerful leadership quiz to help you understand how you show up in the world, personally and professionally. Explore now: www.wilempowered.com, www.wilempowered.com/free-mini-course/

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Latest TROP2 ADC Approval for HR+ HER2- Metastatic Breast Cancer

Medical Industry Feature

Play Episode Listen Later Jan 23, 2026 37:15

Host: Charles Turck, PharmD, BCPS, BCCCP Guest: Kormal Jhaveri, MD, FACP Guest: Vanessa Soto-Romano, RN There's been recent progress with antibody-drug conjugates (ADCs) for HER2-negative breast cancers,1-3 and most recently, patients with metastatic HR+ HER2- breast cancer. The phase III TROPION-Breast01 study examined the efficacy and safety of datopotamab deruxtecan-dInk (Dato-DXd) compared to investigator's choice single-agent chemotherapy, resulting in the approval of this agent in January 2025. Joining Dr. Charles Turck to discuss Dato-DXd for patients with HR-positive, HER2-negative metastatic breast cancer, data from the TROPION-Breast01 trial, and strategies for managing select adverse reactions with this therapy are Dr. Komal Jhaveri and Nurse Vanessa Soto-Romano. Dr. Jhaveri is a breast medical oncologist and early drug development specialist at Memorial Sloan Kettering Cancer Center in New York, and Nurse Soto-Romano is a Clinical Trials Nurse, also at Memorial Sloan Kettering Cancer Center in New York. Dr. Komal JhaveriConsultant/advisory board role: Novartis, Pfizer, Genentech, Eisai, AstraZeneca, Blueprint Medicines, Daiichi Sankyo, Menarini/Stemline, Gilead, Scorpion Therapeutics, Bicycle Therapeutics, Olema Pharmaceuticals, Lilly/Loxo Oncology, Merck Pharmaceuticals, Zymeworks, Halda Therapeutics, Arivinas and RayzebioResearch Funding support to the Institution: Novartis, Genentech, AstraZeneca, Pfizer, Lilly/Loxo Oncology, Zymeworks, Gilead, PUMA Biotechnology, Merck Pharmaceuticals, Scorpion Therapeutics, Rayzebio, Eisai, Bicycle Therapeutics, Bridge Bio Oncology Therapeutics, and Blueprint Medicines. Nurse Soto-RomanoConsultant/advisory board role: AstraZeneca …

new york md pfizer approval astrazeneca gilead novartis pharmd genentech rmd memorial sloan kettering cancer center her2 metastatic breast cancer bcps adcs eisai daiichi sankyo reachmd blueprint medicines oncology and hematology komal jhaveri medical industry feature scorpion therapeutics charles turck host charles turck oncology - hematology

Strategic Shifts and Breakthroughs in Pharma Innovation

PeerView Heart, Lung & Blood CME/CNE/CPE Video Podcast

Play Episode Listen Later Jan 21, 2026 6:56

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the latest transformative movements within this dynamic arena, focusing on pivotal acquisitions, technological integrations, and regulatory updates shaping the future of healthcare solutions.Starting with strategic corporate maneuvers, Pfizer recently divested its 11.7% stake in GSK's ViiV Healthcare, a prominent player in HIV treatments. This $1.875 billion sale to Shionogi reflects Pfizer's strategy to offset anticipated revenue declines while fortifying Shionogi's position in the HIV treatment landscape. For GSK, the transaction brings a $250 million special dividend, highlighting competitive realignments as companies optimize portfolios in the lucrative HIV market.In another significant investment, Roche plans a $2 billion expansion at Genentech's North Carolina site to produce next-generation drugs targeting metabolic conditions like obesity. This move aligns with Roche's strategy to capture a growing market segment driven by the rising prevalence of obesity-related health issues globally.Exelixis is aggressively pursuing its ambition to become a top contender in the U.S. solid tumor market. With its flagship drug Cabometyx at the forefront, Exelixis anticipates promising Phase 3 results for new blockbuster candidates, underscoring its robust oncology-focused growth strategy. This field continues to attract substantial investment due to an unmet need for effective cancer therapies.Turning to regulatory landscapes, a landmark decision is anticipated from the U.S. Supreme Court regarding the "skinny label" dispute between Hikma Pharmaceuticals and Amarin over generic Vascepa. This case could reshape patent litigation strategies and impact how generics are marketed against branded drugs, influencing future industry practices.Meanwhile, AbbVie and Genmab face reassessment after their Phase 3 trial for Epkinly in diffuse large B-cell lymphoma failed to meet survival endpoints. This outcome may prompt a strategic pivot towards pipeline diversification or new partnerships in oncology.Valneva recently withdrew its chikungunya vaccine Ixchiq from U.S. consideration following an FDA investigation into adverse events, highlighting the complex regulatory environment surrounding vaccine approvals and safety protocols. In contrast, Bristol Myers Squibb's collaboration with Microsoft aims to expedite lung cancer diagnosis using AI technology, reflecting a broader trend of integrating digital health solutions into drug development and patient care.GSK's acquisition of Rapt Therapeutics for $2.2 billion further emphasizes its commitment to innovative immunotherapies addressing unmet needs in food allergy treatments. This move aligns with trends towards personalized medicine as companies explore novel mechanisms for targeted therapeutic interventions.In scientific breakthroughs, Merck and Moderna report sustained efficacy in their cancer vaccine collaboration, showing a 49% reduction in melanoma risk over five years when combined with Keytruda. This sets a strong precedent for developing combination therapies that enhance long-term cancer treatment outcomes.Pfizer's $530 million agreement with Novavax seeks to leverage adjuvant technology across its vaccine programs, underscoring Pfizer's commitment to innovation amid ongoing competition within the vaccine market.Oncology advancements continue as AstraZeneca secures full rights to an armored CAR-T therapy from Abelzeta for $630 million. Targeting glypican-3 proteins associated with certain cancers, this acquisition highlights AstraZeneca's push into advanced cell therapies that promise revolutionary cancer care solutions.Beyond these corporate strategies, ARPA-H envisions transcending traditional vaccine technologies through innovative solutions that could render vSupport the show

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Stephen V. Liu, MD - Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease

Play Episode Listen Later Jan 14, 2026 55:27

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/AAPA information, and to apply for credit, please visit us at PeerView.com/PYJ865. CME/AAPA credit will be available until January 5, 2027.Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease 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 independent medical education grants from Amgen; Genentech, a member of the Roche Group; and Jazz Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

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Stephen V. Liu, MD - Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease

PeerView Clinical Pharmacology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jan 14, 2026 55:27

Stephen V. Liu, MD - Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease

PeerView Oncology & Hematology CME/CNE/CPE Video Podcast

Play Episode Listen Later Jan 14, 2026 55:27

Stephen V. Liu, MD - Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease

PeerView Oncology & Hematology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jan 14, 2026 55:27

Stephen V. Liu, MD - Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease

PeerView Heart, Lung & Blood CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jan 14, 2026 55:27

Stephen V. Liu, MD - Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease

PeerView Clinical Pharmacology CME/CNE/CPE Video

Play Episode Listen Later Jan 14, 2026 55:27

Komal Jhaveri, MD, FACP - Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions

PeerView Clinical Pharmacology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jan 13, 2026 81:46

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/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/NXT865. CME/MOC/NCPD/AAPA/IPCE credit will be available until January 15, 2027.Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Living Beyond Breast Cancer. 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 independent educational grants from AstraZeneca, Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics, a Menarini Company Group.Disclosure information is available at the beginning of the video presentation.

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Komal Jhaveri, MD, FACP - Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions

PeerView Oncology & Hematology CME/CNE/CPE Video Podcast

Play Episode Listen Later Jan 13, 2026 81:46

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/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/NXT865. CME/MOC/NCPD/AAPA/IPCE credit will be available until January 15, 2027.Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Living Beyond Breast Cancer. 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 independent educational grants from AstraZeneca, Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics, a Menarini Company Group.Disclosure information is available at the beginning of the video presentation.

Komal Jhaveri, MD, FACP - Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions

PeerView Internal Medicine CME/CNE/CPE Video Podcast

Play Episode Listen Later Jan 13, 2026 81:46

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/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/NXT865. CME/MOC/NCPD/AAPA/IPCE credit will be available until January 15, 2027.Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Living Beyond Breast Cancer. 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 independent educational grants from AstraZeneca, Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics, a Menarini Company Group.Disclosure information is available at the beginning of the video presentation.

Komal Jhaveri, MD, FACP - Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions

PeerView Internal Medicine CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jan 13, 2026 81:46

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/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/NXT865. CME/MOC/NCPD/AAPA/IPCE credit will be available until January 15, 2027.Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Living Beyond Breast Cancer. 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 independent educational grants from AstraZeneca, Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics, a Menarini Company Group.Disclosure information is available at the beginning of the video presentation.

Komal Jhaveri, MD, FACP - Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions

PeerView Oncology & Hematology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jan 13, 2026 81:46

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/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/NXT865. CME/MOC/NCPD/AAPA/IPCE credit will be available until January 15, 2027.Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Living Beyond Breast Cancer. 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 independent educational grants from AstraZeneca, Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics, a Menarini Company Group.Disclosure information is available at the beginning of the video presentation.

Komal Jhaveri, MD, FACP - Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions

PeerView Clinical Pharmacology CME/CNE/CPE Video

Play Episode Listen Later Jan 13, 2026 81:46

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/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/NXT865. CME/MOC/NCPD/AAPA/IPCE credit will be available until January 15, 2027.Dialing Up Precision in HR+, HER2- MBC With New Endocrine Agents, Targeted Therapies, and Combinations: A Framework for Multifactorial Clinical Decisions In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Living Beyond Breast Cancer. 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 independent educational grants from AstraZeneca, Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics, a Menarini Company Group.Disclosure information is available at the beginning of the video presentation.

Immuno-Oncology Advances and CRISPR Innovations: Key Industry Shifts

Play Episode Listen Later Jan 12, 2026 5:21

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of transformative updates reshaping drug development and patient care across the globe.Starting with a major collaboration between Roche and Medilink Therapeutics that has captured industry attention. Roche is making a strategic move by committing $570 million to partner on an antibody-drug conjugate, or ADC, targeting the B7-H3 immune checkpoint protein. This partnership underscores a broader industry trend focusing on immuno-oncology. ADCs have become pivotal due to their ability to deliver cytotoxic agents precisely to tumor cells, reducing systemic exposure and minimizing side effects. This precision not only enhances efficacy but also improves patient experience, marking a significant stride in cancer treatment modalities.In another strategic alliance, Pfizer has entered into a $50 million deal with Madrigal Pharmaceuticals for a DGAT2 inhibitor. Madrigal plans to pair this with its liver disease treatment, Rezdiffra, aiming to amplify therapeutic outcomes in liver conditions. This highlights an increasingly popular approach in medicine: polypharmacy and combination therapies. By tackling diseases from multiple angles, these therapies promise more comprehensive management of complex conditions, reflecting a shift towards more personalized and effective treatment strategies.Turning our attention to the startup landscape, "Baby KJ" Scientist has launched a new personalized CRISPR therapy company with $16 million in initial funding from Menlo Ventures. This venture signals growing interest in CRISPR technology for crafting bespoke genetic therapies. The potential for CRISPR lies in its ability to edit genomes precisely, opening possibilities for treating genetic disorders at their root cause and tailoring interventions to individual patients' genetic profiles.On the financial front, Aktis Oncology's successful IPO stands out, raising an impressive $318 million through an upsized offering. This achievement not only illustrates investor confidence in biotech but also suggests a more favorable atmosphere for upcoming biotech ventures seeking public funding. A robust financial ecosystem is crucial for fostering innovation and bringing cutting-edge therapies from the lab bench to the bedside.In another exciting development, Airnexis Therapeutics has secured $200 million to advance its COPD treatment asset in collaboration with a Chinese pharmaceutical firm. The total deal could reach up to $955 million in what's known as biobucks—a term used for milestone payments in biotech partnerships. This collaboration exemplifies the globalization of biotech partnerships, emphasizing the strategic importance of tapping into diverse markets for drug development and commercialization.Meanwhile, Ollin Biosciences is making waves with promising results from its bispecific antibody trial. The antibody showed superior efficacy in treating diabetic macular edema compared to Genentech's Vabysmo. This success potentially sets a new benchmark for retinal disease therapies and highlights the rapid evolution of bispecific antibodies. These agents can engage multiple targets simultaneously, offering enhanced therapeutic potential across various conditions.Leadership dynamics are also influencing the sector. Charles Fuchs has transitioned from his role as Roche's Global Head of Oncology and Hematology Product Development to Tubulis. Such moves suggest potential shifts in strategic focus for both companies involved, reflecting broader trends in leadership realignments within the industry. Additionally, Illumina's appointment of Eric Green as Chief Medical Officer showcases another instance of experienced leaders taking pivotal roles within companies at the forefront of genomic research. Such appointments underscore the imSupport the show

Expanding Treatment Options for Breast Cancer: ADCs and Oral SERDs

Play Episode Listen Later Jan 8, 2026 27:14

Dr. Monty Pal and Dr. Hope Rugo discuss advances in antibody-drug conjugates for various breast cancer types as well as treatment strategies in the new era of oral SERDs for HR-positive breast cancer. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist and vice chair of academic affairs here at the City of Hope Comprehensive Cancer Center, Los Angeles. Today, I'm thrilled to be joined by Dr. Hope Rugo, an internationally renowned breast medical oncologist and my colleague here at City of Hope, where she leads the Women's Cancers Program and serves as division chief of breast medical oncology. Dr. Rugo is going to share with us exciting advances in antibody-drug conjugates (ADCs) that are expanding treatment options in various breast cancer types. She'll also address some of the complex questions arising in the new era of oral SERDs (selective estrogen receptor degraders) that are revolutionizing treatment in the hormone receptor-positive breast cancer space. Our full disclosures are available in the transcript of this episode. Dr. Rugo, welcome, and thanks so much for being on the podcast today. Dr. Hope Rugo: Thank you. Pleasure to be here. Dr. Monty Pal: So, I'm going to switch to first names if you don't mind. The first topic is actually a really exciting one, Hope, and this is antibody-drug conjugates. I don't know if I've ever shared this with you, but I actually started my training at UCLA, I was a med student and resident there, and it was in Dennis Slamon's lab. I worked very closely with Mark Pegram and a handful of others. This is right around the time I think a lot of HER2-directed therapies were really evolving initially in the clinics. Now we've got antibody-drug conjugates. Our audience is well-familiar with the mechanism there but tell us about how ADCs have really started to reshape therapy for HER2-positive breast cancer. Dr. Hope Rugo: Yeah, I mean, this is a really great place to start. I mean, we have had such major advances in breast cancer just this year, I think really changing the paradigm of treating patients. But HER2-positive disease, we've been used to having sequenced success of new agents. And I think the two biggest areas where we've made advances in HER2-positive disease, which were remarkably advanced this year in 2025, have been in antibody-drug conjugates with trastuzumab deruxtecan and with new oral tyrosine kinase inhibitors (TKIs) that have less of a target on EGFR and more on HER2, so they have an overall more tolerable toxicity profile and therefore a potentially better efficacy in the clinic. At least that's what we're seeing with these new strategies that we couldn't really pursue in the past because of toxicities of the oral TKIs. So, although our topic is ADCs, I'm going to include the TKI because it's so important in our thinking about treating HER2-positive disease. In the metastatic setting, we've seen these remarkable improvements in progression-free and overall survival in the second-line setting with T-DXd, or trastuzumab deruxtecan, compared to T-DM1. And then sequencing ADCs with giving T-DXd after T-DM1 was better than an oral tyrosine kinase or a trastuzumab combination with standard chemotherapy. That was DESTINY-Breast03 and DESTINY-Breast02. So, then we've had other trials since then, and T-DXd has moved into the early-stage setting, which I'll talk about in just a moment. But the next big trial for T-DXd in HER2-positive disease was moving it to the first-line setting to supplant what has become an established treatment for now quite a long time: the so-called CLEOPATRA regimen, which used the combined antibodies trastuzumab, pertuzumab with a taxane as first-line therapy. And then we've proceeded on with maintenance with ongoing HP for patients with responding or stable disease. And we'd seen long-term data showing, you know, at 8 years there was a group of patients whose cancers had never progressed and continued improved overall survival. So, T-DXd was studied in DESTINY-Breast09, either alone or in combination with pertuzumab compared to THP. The patient population had received a little bit more prior treatment, but interestingly, not a lot compared to CLEOPATRA. And they designed the trial to be T-DXd continued until progression with or without pertuzumab versus THP, which would go for six cycles and then stop around six cycles, and then stop and continue HP. Patients who had hormone receptor-positive disease could use hormone therapy, and this is one of the issues with this dataset because, surprisingly in this dataset and one other I'll mention, very few patients took hormone therapy. And even in the maintenance trial, the HER2CLIMB-05, less than 50% took hormone therapy as maintenance. This is kind of shocking to me and highlights an area of really important education, that outcome is improved when you add endocrine therapy for hormone receptor-positive HER2-positive metastatic disease in the maintenance phase, and it's a really important part of treatment. But suffice it to say, you know, you're kind of studying continued chemo versus stopping chemo in maintenance. And T-DXd, as we all expected, in combination with pertuzumab was superior to THP in terms of progression-free survival, really remarkably improved. And you could stop the chemo with toxicity, but most people continued it with T-DXd. Again, not a lot of people got hormone therapy, which is an issue, and you stop the chemo in the control arm. So, this has brought up a lot of interest in trying to use T-DXd as an induction and then go to maintenance, much as we do with the CLEOPATRA regimen with hormone therapy. But it brings up another issue. So first, T-DXd is superior; it's a great treatment. Not everybody needs to have it because we don't know whether it's better to give T-DXd first or second with progression - that we need a little bit longer follow-up. But just earlier this week, interestingly, the third week of December, the U.S. FDA approved T-DXd in the DESTINY-Breast09 approach with pertuzumab. So as I mentioned earlier, there was a T-DXd-alone arm; that arm has not yet reported. So very interesting, we don't know if you need pertuzumab or not. So what about the maintenance? That's the other area where we've made a huge advance here. So, we all want to stop chemo and we want to stop T-DXd. You don't want somebody being nauseated for two years while they're on treatment, and also there's a small number of patients with mostly de novo metastatic HER2-positive disease who are cured of their disease. We'd like to expand that, and I think these new drugs give us the opportunity to improve the number of patients who might be cured from metastatic disease. So the first maintenance study we saw was adding palbociclib, the CDK4/6 inhibitor, to endocrine therapy and HP, essentially. There, we had a remarkable improvement in progression-free survival difference of 15.2 months: 29 to 44 months, really huge. At San Antonio this year, we saw data with this oral tyrosine kinase inhibitor tucatinib, already showed it was great in a triplet, but as maintenance in combination with HP, it showed also a remarkable improvement in progression-free survival. But the numbers were all shifted down. So in PATINA, the control arm was in the 24-month range; here it was the tucatinib-HP arm that was in the 25 months and 16 months for control. So there was a differential benefit in ER-negative and ER-positive disease. So I think we're all thinking that our ideal approach moving forward would be to give T-DXd to most patients, we see how they do, and treat to best response. And then, stop the T-DXd, start HP, trastuzumab, pertuzumab for ER-negative, with tucatinib for ER-positive with palbociclib. We also have early data that suggests that both approaches may reduce the development of brain metastases, an issue in HER2-positive disease, and delay time to progression of brain metastases as seen in HER2CLIMB-05 in very early data - small numbers, but still quite intriguing that you might delay progression of brain metastases with tucatinib that clearly has efficacy in the brain. So, I think that this is a hugely exciting advance for our patients, and these approaches are quickly moving into the early stage setting. T-DXd compared to standard chemo, essentially followed by THP, so a sequenced approach resulted in more pathologic complete responses than a standard THP-AC-type neoadjuvant therapy. T-DXd alone for eight cycles wasn't better, and that's interesting. We still need the sequenced non-cross-resistant chemo. But I think even more importantly, the data from DESTINY-Breast05 looking at T-DXd versus T-DM1 in patients with residual disease after neoadjuvant HER2-targeted therapy showed a remarkable improvement in invasive disease-free survival with T-DXd versus T-DM1, and quite early. It was a high-risk population, higher risk than the T-DM1 trial with KATHERINE, but earlier readout with a remarkable improvement in outcome. We expect to be FDA approved sometime in the first half of 2026. So then we'll get patients who've already had T-DXd who get metastatic disease. But my hope is that with T-DXd, maybe with tucatinib in the right group of patients or even sequenced in very high-risk disease, that we could cure many more patients with early-stage HER2-positive breast cancer and cure a subset, a greater subset of patients with de novo metastatic disease. Dr. Monty Pal: That's brilliant. And you tackled so many questions that I was going to follow up with there: brain metastases, etc. That was sort of looming in my mind. I mean, general thoughts on an ADC versus a TKI in the context of brain mets? Dr. Hope Rugo: Yeah, it's an interesting question because T-DXd has shown quite good efficacy in this setting. And tucatinib, of course, had a trial where they took patients with new brain mets, so a larger population than we've seen yet for the T-DXd trials, and saw that not only did they delay progression of brain metastases and result in shrinkage of existing untreated brain mets, but that patients who develop a new brain met, they could stay on the same assigned treatment. They got stereotactic radiation, and then the patients who were on tucatinib with trastuzumab and capecitabine had a further delay in progression of brain mets compared to those on the placebo arm, even after treatment of a new one that developed on treatment. So, I think it's hard. I think most of us for a lot of brain mets might start with the tucatinib approach, but T-DXd is also a very important treatment. You know, you're kind of trading off a diarrhea, some liver enzyme elevations with tucatinib versus nausea, which you really have to work on managing because it can be long-delayed nausea, and this risk of ILD, interstitial lung disease, that's about 12%, with most but not all trials showing a mortality rate from interstitial lung disease of just under 1 percent. In the early-stage setting, it was really interesting to see that with T-DXd getting four cycles in the neoadjuvant setting, a lot less ILD noted than the patients who got up to 14 cycles, as I think they got a median of 10 cycles in the post-surgical setting, there was a little bit more ILD. But I think we're going to be better and better at finding this earlier and preventing mortality by just stopping drug and treating earlier with steroids. Dr. Monty Pal: And this ILD issue, it always seems to resurface. There are drugs that I use in my kidney cancer clinic, everolimus, common to perhaps the breast cancer clinic as well, pembrolizumab, where I think the pattern of pneumonitis is quite different, right? What is your strategy for recognizing pneumonitis early in this context? Dr. Hope Rugo: Well, it is, and you know, having done the very early studies in everolimus where we gave it in the neoadjuvant setting and we're like, "Hmm, the patient came in with a cough. What's going on?" You know, we didn't know. And you have mouth sores, you know, we were learning about the drug as we were giving it. What we don't do with everolimus and CDK4/6 inhibitors, for example, is grade 1 changes like radiation pneumonitis, we don't stop, we don't treat it. We only treat for symptoms. But because of the mortality associated with T-DXd, albeit small, we stop drug for grade 1 imaging-only asymptomatic pneumonitis, and some of us treat with a half dose of steroids just to try and hasten recovery. We've actually now published or presented a couple of datasets from trials, a pooled analysis and a real-world analysis, that have looked at patients who were retreated after grade 1 pneumonitis or ILD and tolerated drug very well and none of them died of interstitial lung disease, which was really great to see because you can retreat safely and some of these patients stayed on for almost a year benefiting from treatment. So, there's a differential toxicity profile with these drugs and there are risk factors which clearly have identified those at higher risk: prior ILD, for example. A French group said smoking; other people haven't found that, maybe because they smoked more in France, I don't know. And being of Japanese descent is quite interesting. The studies just captured that you were treated in Japan, but I think it's probably being of Japanese descent with many drugs that increases your risk of ILD. And, you know, older patients, people who have hypoxia, those are the patients. So, how do we do this? With everolimus, we don't have specific monitoring. But for T-DXd we do; we do every nine weeks to start with and then every 12 weeks CT scans because most of the events occur relatively early. Somebody who's older and at higher risk now get the first CT at six weeks. Dr. Monty Pal: This is super helpful. And I have to tell you, a lot of these drugs are permeating the bladder cancer space which, you know, is ultimately going to be a component of my practice, so thank you for all this. We could probably stay on this topic of HER2-positive disease forever. I'm super interested in that space still. But let me shift gears a little bit and talk about triple-negative breast cancer and this evolving space of HR-positive, HER2-low breast cancer. I mean, tell us about ADCs in that very sort of other broad area. Dr. Hope Rugo: So triple-negative disease is the absolute hardest subset of disease that we have to treat because if you don't have a great response in the early stage setting, the median survival is very short, you know, under two years for the majority of TNBCs, with the exception of the small percentage of low proliferative disease subsets. The co-question is what do we do for these patients and how do we improve outcome? And sacituzumab govitecan has been one strategy in the later line setting that was shown to improve progression-free and overall survival, the Trop-2 ADC. We had recently three trials presented with the two ADCs, sacituzumab govitecan and the other Trop-2 ADC that's approved for HR-positive disease, datopotamab deruxtecan. And they were studied in the first-line setting. Two trials with SG, sacituzumab govitecan, those trials, one was PD-L1 positive, ASCENT-04. That showed that SG with a checkpoint inhibitor was superior, so pembrolizumab was superior to the standard KEYNOTE-355 type of treatment with either a taxane or gemcitabine and carboplatin with pembrolizumab for patients who have a combined positive score for PD-L1, 10 or greater. So, these are patients who are eligible for a checkpoint inhibitor, and SG resulted in an improved progression-free survival. The interesting thing about that dataset is that few patients had received adjuvant or neoadjuvant checkpoint inhibitor, which is fascinating because we give it to everybody now. But access is an issue and timing of the study enrollment was an issue. The other thing which I think we've all really applauded Gilead for is that there was automatic crossover. So, you could get from the company, to try and overcome some of the enormous disparities worldwide in access to these life-saving drugs, you could get SG through the company for free once you had blinded independent central review confirmation of disease progression. Now, a lot of the people who got the SG got it through their insurance, they didn't bill the company, but 80 percent of patients in the control arm received SG in the second-line setting. So that impacts your ability to look at overall survival, but it's an incredibly important component of these trials. So then at ESMO, we saw the data from SG and Dato-DXd in the first-line metastatic setting for patients who either had PD-L1-negative disease or weren't eligible for an immunotherapy. For the Dato study, TROPION-Breast02, that was 10 percent of the patients who had PD-L1-positive disease but didn't get a checkpoint inhibitor, and for the ASCENT-03 trial population it was only 1 percent. Importantly, the trials allowed patients who relapsed within a year of receiving their treatment with curative intent, and the Dato study, TB-02, allowed patients who relapsed while on treatment or within the first six months, and that was 15 percent of the 20 percent of early relapsers. The ASCENT trial, ASCENT-03, had 20 percent who relapsed between 6 and 12 months. The drugs were better than standard of care chemotherapy, the ADCs in both trials, which is very nice. Different toxicity profiles, different dosing intervals, but better than standard of care chemotherapy in the disease that's hardest for us to treat. And importantly, when you looked at the subset of early relapsers, those patients also did better with the ADC versus chemotherapy, which is incredibly important. And we were really interested in that 15 percent of patients who had early relapse. I actually think that six months thing was totally contrived, invented, you know, categorization and doesn't make any sense, and we should drop it. But the early relapsers were 15 percent of TB-02 and Dato was superior to standard of care chemo. We like survival, but the ASCENT trial again allowed the crossover to an approved ADC that improved survival and 80 percent of patients crossed over. In the Dato trial, they did not allow crossover, they didn't provide Dato, which isn't approved for TNBC but is for HR-positive disease, and they didn't allow, of course, pay for SG. So very few patients actually crossed over in their post-treatment data and in that study, they were able to show a survival benefit. So actually, I think in the U.S. where we can use approved drugs already before there's a fixed FDA approval, that people are already switching to use SG or Dato in the first-line setting for metastatic TNBC that's both PD-L1 positive for SG and PD-L1 negative for both drugs. And I think understanding the toxicity profiles of the two drugs is really important as well as the dosing interval to try and figure out which drug to use. Dr. Monty Pal: Brilliant. Brilliant. Well, I'm going to shift gears a little bit. ADCs are a topic, again, just like HER2-positive disease we could stay on forever. Dr. Hope Rugo: Huge. Yes. Dr. Monty Pal: But we're going to shift gears to another massive topic, which is oral SERDs. In broad strokes, right, this utilization of CDK4/6 inhibitors in the context of HR-positive breast cancer is obviously, you know, a paradigm that's been well established at this point. Where do we sequence in oral SERDs? Where do they fit into this paradigm? Dr. Hope Rugo: Ha! This is a rapidly changing area; we keep changing what we're saying every other minute. And I think that there are three areas of great interest. So one is patients who develop ESR1 mutations that allow constitutive signaling through the estrogen receptor, even when there's not estrogen around, and that is a really important mutation that is subclonal; it develops under the pressure of treatment in about 40 percent of patients. And it doesn't happen when you first walk in the door. And what we've seen is that oral SERDs as single agents are better than standard single-agent endocrine therapy in that setting. The problem that we've had with that approach is that we're now really interested in giving targeted agents with our endocrine therapies, not just in the first-line setting where CDK4/6 inhibitors are our standard of care with survival benefit for ribociclib and, you know, survival benefit in subsets with other CDK4/6 inhibitors, and abemaciclib with a numeric improvement. So we give it first line. The question is, what do you do in the second-line setting? Because of the recent data, we now believe that oral SERDs should be really given with a targeted agent. And some datasets which were recently presented, which I think have helped us with that, have been EMBER-3 and then the most recently evERA BC, or evERA Breast Cancer, that looked at the oral SERD giredestrant with everolimus compared to standard of care endocrine therapy with everolimus, where 100 percent of patients received prior CDK4/6 inhibitor and showed a marked improvement in progression-free survival, including in the subsets of patients with a short response, 6-12 months of prior response to CDK4/6 inhibitor and in those who had a PIK3CA pathway mutation. The thing is that the benefit looks like it's much bigger in the ESR1 mutant population, although response was better, PFS wasn't better in the wild type. So, we're still trying to figure that out. We also saw EMBER-3 with imlunestrant and abemaciclib as a second line. Not everybody had had a prior CDK4/6 inhibitor; they compared it to imlunestrant alone, but still the data was quite striking and seemed to cross the need for ESR1 mutations. And then lastly, we saw data from the single arms of the ELEVATE trial looking at elacestrant with everolimus and abemaciclib and showed these really marked progression-free survival data, even though single-arm, that crossed the mutation status. At least for the everolimus combination, abemaciclib analysis is still to come in the mutated subgroups. But really remarkable PFS, much longer. Single-agent fulvestrant after CDK4/6 inhibitor AI has a PFS in like the three-month range and in some studies, maybe close to five months. These are all at 10-plus months and really looking very good. And so those questions are, is it ESR1 mutation alone? Is it all comers? We'd like all comers, right? We believe in the combination approach and we're learning more about combinations with drugs like capivasertib and other drugs as we move forward. Everybody now wants to combine their targeted agent with an oral SERD because they're clearly here to stay with quite remarkable data. The other issue, so the second issue in the metastatic setting is, does it make a difference if we change to an oral SERD before radiographic imaging evidence of progression? And that was the question asked in the SERENA-6 trial where patients had serial monitoring for the presence of ESR1 mutations in ctDNA. And those who had them without progression on imaging could be randomized to switch to camizestrant with the same CDK4/6 inhibitor or stay on their same AI CDK4/6 inhibitor. And they showed a difference in progression-free survival that markedly favored camizestrant. But interestingly, the people who were on the standard control arm had an ESR1 mutation, we think AIs don't work, they stayed on for nine more months. The patients who were on the camizestrant stayed on for more than 16 months. And they presented some additional subset data which showed the same thing: follow-up PFS data, PFS2, all beneficial in SERENA-6 at the San Antonio [Breast Cancer Symposium]. So, we're still a little bit unclear about that. They did quality of life, and pain was markedly improved. They had a marked delayed time to progression of pain in the camizestrant arm. So this is all a work in progress, trying to understand who should we switch without progression to an oral SERD based on this development of this mutation that correlates with resistance. And, you know, it's interesting because the median time to having a mutation was 18 months and the median time to switch was almost 24 months. And then there were like more than 3,000 patients who hadn't gotten a mutation, hadn't switched, and were still okay. So screening everybody is the big question, and when you would start and who you would change on and how this affects outcome. Patients didn't have access to camizestrant in the control arm, something we can't fix but we have experimental drugs. We're actually planning a trial, I hope in collaboration with the French group Unicancer, and looking at this exact question. You know, if you switch and you change the CDK4/6 inhibitor and then you also allow crossover, what will we see? Dr. Monty Pal: We're coming right to the tail end of our time here, and I could probably go on for another couple of hours with you here. But if you could just give us maybe one or two big highlights from San Antonio, any thoughts to leave our audience with here based on this recent meeting? Dr. Hope Rugo: Yeah, I mean, I talked about a lot of those new data already from San Antonio, and the one that I'd really like to mention which I think was, you know, there were a lot of great presentations including personalized screening presented from the WISDOM trial by my colleague Laura Esserman, fascinating and really a big advance. But lidERA was the big highlight, I think, outside of the HER2CLIMB-05 which I talked about earlier in HER2-positive disease. And this study looked at giredestrant, the oral SERD versus standard of care endocrine therapy as treatment for medium and high-risk early-stage breast cancer. And what they showed, which I think was really remarkable with just about a three-year median follow-up, was an improvement in invasive disease-free survival with a hazard ratio of 0.7. I mean, really quite remarkable and so early. It looked as though this was all driven by the high-risk group, which makes sense, not the medium risk, it's too early. And also that there was a bigger benefit in patients who were on tamoxifen compared to giredestrant versus AI, but for both groups, the confidence intervals didn't cross 1. There's even a trend towards overall survival, even though it's way too early. I think that, you know, really well-tolerated oral drug that could improve outcome in early-stage disease, this is the first advance we've seen in over two decades in the treatment of early-stage hormone receptor-positive disease with just endocrine therapy. I think we think that we don't want to give up CDK4/6 inhibitors because we saw a survival benefit with abemaciclib and a trend with giving ribociclib in the NATALEE trial. So we're thinking that maybe one approach would be to give CDK4/6 inhibitors and then switch to an oral SERD or to have enough data to be able to give oral SERDs with these CDK4/6 inhibitors for early-stage disease. And that's all in the works, you know, lots of studies going on. We're going to see a lot of data with both switching 8,000 patients with an imlunestrant switching trial, an elacestrant trial going on, and safety data with giredestrant with abemaciclib and soon to come ribociclib. So, this is going to change everything for the treatment of early-stage breast cancer, and I hope cure more patients of the most common subset of the most common cancer diagnosed in women worldwide. Dr. Monty Pal: Super exciting. It's just remarkable to hear how this has evolved since 25 years ago, which is really the last time I sort of dabbled in breast cancer. Thank you so much, Hope, for joining us today. These were fantastic insights. Appreciate you being on the ASCO Daily News Podcast and really want to thank you personally for your remarkable contribution to the field of breast cancer. Dr. Hope Rugo: Thank you very much, and thanks for talking with me today. Dr. Monty Pal: You got it. And thanks a lot to our listeners today as well. You'll find links to all the studies we discussed today in the transcript of this episode. Finally, if you value the insights that you hear today on the ASCO Daily News Podcast, please 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 opinion 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. Monty Pal @montypal Dr. Hope Rugo  @hoperugo Follow ASCO on social media:       ASCO on X ASCO on Bluesky      ASCO on Facebook       ASCO on LinkedIn       Disclosures:     Dr. Monty Pal:   Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview  Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical  Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis  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

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PulseCast: Highlights in MDS/MPNs From the 2025 ASH Annual Meeting

The Itch: Allergies, Asthma & Immunology

Play Episode Listen Later Dec 30, 2025 14:59

In this podcast episode, Rami Komrokji, MD, reviews data from select presentations in myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPNs) presented at the ASH 2025 Annual Meeting and shares expert perspectives on the clinical implications of these findings, including:Abstract 910: MANIFEST-2 96-Wk Update: Ruxolitinib + Pelabresib or Placebo in Patients With JAK Inhibitor–Naive MFAbstract 1024: Phase I Trial of INCA033989, a First-in-Class Antibody Targeting Mutant Calreticulin: Safety and Efficacy in Essential ThrombocythemiaAbstract 484: Preliminary Results From 2 Phase I Trials Exploring the Mutant Calreticulin-Specific mAb INCA033989 ± Ruxolitinib in Patients With MFAbstract 235: VERONA: Subgroup Analyses of Venetoclax or Placebo Combined With Azacitidine in Treatment-Naive Higher-Risk MDSAbstract 490: IMerge Post Hoc Analysis: Treatment-Emergent Cytopenias and Response With Imetelstat in Patients With Lower-Risk MDSAbstract 487: Randomized Phase II Trial of Reduced Treatment Durations of Hypomethylating Agents for Lower-Risk MDSPresenter: Rami Komrokji, MDSenior Member, Vice ChairSection Head – Leukemia and MDSDepartment of Malignant HematologyH. Lee Moffitt Cancer CenterProfessor of Oncologic SciencesUniversity of South FloridaTampa, FloridaContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program: https://bit.ly/48Ye45N Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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151. Change Your Words, Change Your Life. The Power of "I Get To" w/ Founder, Author, & Global Speaker Chris Cullen

Seeds of Success Podcast

Play Episode Listen Later Dec 23, 2025 67:38

Most of us live in autopilot. We rush through our days, carry the weight of stress, and get buried under pressure. We say things like "I have to go to work" or "I have to deal with this" and "I have to keep pushing." But what if you replaced one word and changed everything?"I Get To" is not just a phrase - it's a practice. One that moves you from obligation to opportunity, from burnout to presence, from pressure to purpose.Whether you're an athlete, executive, leader, coach, parent, or anyone navigating challenge or change, "I Get To" reminds you that your mindset isn't just part of the journey - it is the journey.Who is Chris Cullen?Global keynote speaker, mindset coach, author, and founder of Win Within, Chris Cullen helps high achievers build meaningful lives from the inside out. After a decade leading teams and driving over $100M in sales, Chris walked away from a high-performing career to pursue teaching people how to lead themselves well.Through his work with elite athletes, Fortune 500 teams, and growth-minded individuals, Chris teaches how to apply the "I Get To" mindset - a simple but powerful shift in perspective that builds resilience, presence, and intention. Two-time Ironman finisher, former Division 1 and professional athlete, and founder of Win Within, Chris blends grit with grounded self-awareness. His work reminds us that the life we want isn't found in more hustle - it's built through perspective, presence, and choice.Chris lives his message daily and believes the most important words you'll ever say to yourself are the ones you practice when life gets hard.Today, his mission is clear: to help companies and high achievers push beyond limits, sharpen their mindset, and unlock their next level of performance.Chris's innovative trainings on mindset, culture, and high performance have been utilized by some of the world's best organizations including: Qualtrics, Marriott, Genentech, Jersey Mike's, Stryker, USA Volleyball, Michigan State University, and the University of Georgia Athletics.Connect with Chris:► LinkedIn► Instagram► Website► Buy the book: "I Get To"

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The Big Picture on Non-Hodgkin Lymphoma: Treatments, Trends, and Tomorrow

The Bloodline with LLS

Play Episode Listen Later Dec 22, 2025 44:20

Jean Koff, MD, MSc Non-Hodgkin lymphoma (NHL) can sound overwhelming, but what does it really mean for patients and families? In this episode, we speak to Dr. Jean Koff of Winship Cancer Institute of Emory University, who breaks down the big picture of NHL: what it is, how it's an umbrella term for multiple subtypes, and what today's treatments and tomorrow's innovations could mean for you. From understanding subtypes and staging to exploring options like watchful waiting, chemotherapy, and cutting-edge immunotherapies, we cover what matters most: knowledge, clarity, and hope. DOWNLOAD TRANSCRIPT CLICK HERE to participate in our episode survey. Mentioned on this episode: Non-Hodgkin lymphoma The Lymphoma Guide Lugano staging system Immunotherapy fact sheet CAR T-cell therapy Allogeneic stem cell transplantation Clinical Trial Support Center Online NHL Chat Additional Blood Cancer United Support Resources: Free Nutrition Consultations Information Specialists Financial support Free telephone/web patient programs Free booklets Young Adult Resources Support groups Caregiver support Caregiver Workbook Survivorship Workbook Advocacy and Public Policy Patient Community Mental Health Resources Supported by AbbVie Inc. and Genentech, A Member of the Roche Group.The post The Big Picture on Non-Hodgkin Lymphoma: Treatments, Trends, and Tomorrow first appeared on The Bloodline with Blood Cancer United Podcast.

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#139 - Understanding Food Allergy Labels & "May Contain" in the U.S.

Play Episode Listen Later Dec 22, 2025 39:03

Reading food labels can feel like a full-time job when you or your child has food allergies. Even when you know what to avoid, labels can still be confusing, especially when you run into “may contain” warnings. Marion Groetch, a registered dietitian with decades of experience in food allergy care and education, joins us to unpack all things food labels. Together, we break down U.S. allergen labeling laws, what parts of the package actually matter, and why “may contain” statements are a much grayer area than most people realize. We also share practical tips for navigating so-called “mystery ingredients” like natural flavors and oils, when it is worth contacting a manufacturer, and how to avoid being more restrictive than necessary while still staying safe. What we cover in our episode about food labels: What U.S. labeling laws require: How FALCPA and the FASTER Act protect families by requiring clear disclosure of the Top 9 major allergens. Where allergy information actually lives on a label: Why the ingredients list and “Contains” statement matter most, and why front-of-package claims should be ignored. What “may contain” actually means: Why these statements are voluntary and unregulated, and what that means for real-world decision-making. Foods that fall outside labeling laws: Common situations where allergen labeling is not required, including deli foods, restaurant meals, airline meals, and alcohol. How to avoid over-restricting your diet: Practical guidance on mystery ingredients, higher-risk products, and when contacting a manufacturer actually makes sense. ___ Made in partnership with The Allergy & Asthma Network. Thanks to Genentech for sponsoring today's episode. This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

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PulseCast: Highlights in Lymphomas From the 2025 ASH Annual Meeting

Performance Matters | A 5 Moments of Need Podcast Series

Play Episode Listen Later Dec 19, 2025 14:25

In this podcast episode, Jeremy S. Abramson, MD, MMSc, reviews data from select presentations in lymphomas at the ASH 2025 Annual Meeting and provides perspectives on the clinical implications of these data for patients with chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL), including:CLL17: randomized phase III trial of continuous ibrutinib vs fixed-duration venetoclax plus obinutuzumab or venetoclax plus ibrutinib for untreatedCLL BRUIN CLL-313: randomized phase III trial of pirtobrutinib vs BR for previously untreated patients with CLLBRUIN CLL-314: pirtobrutinib vs ibrutinib in treatment-naive and BTKi-naive R/R CLL/SLL EPCORE-FL-1: randomized phase III trial of epcoritamab with rituximab and lenalidomide vs rituximab and lenalidomide for R/R FLSTARGLO: 3-year follow-up data from the randomized phase III trial of glofitamab plus GemOx vs rituximab plus GemOx for patients with R/R DLBCLPresenter: Jeremy S. Abramson, MD, MMScProfessor of MedicineHarvard Medical SchoolDirector, Center for LymphomaMass General Brigham Cancer InsBoston, MassachusettsContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program:https://bit.ly/4aqMobZ Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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Leading Through Disruption: What AI Really Demands of L&D

Play Episode Listen Later Dec 18, 2025 31:56

As organizations race to adopt AI, learning leaders face a critical challenge: how to embrace innovation without losing sight of performance. In this episode of Performance Matters, Bob Mosher is joined by Frank Nguyen for a candid, thoughtful conversation about what responsible L&D leadership looks like in an era of rapid disruption. Drawing on Frank's experience across industries—from Amazon to Genentech—the discussion explores how learning teams can move beyond order-taking to become true strategic partners. Together, they unpack the balance between delivering today's results while preparing for tomorrow, the risks of being distracted by AI hype, and why performance—not content or tools—must remain the north star. Listen or download now. Have questions about this content or another resource on the site? Let us know! Use this form to let us know you're interested in scheduling a call with a member of the team. We're always happy to discuss your current, future, or aspirational initiatives in real-time. For more 5 Moments of Need resources, visit our website, join the conversation, attend our upcoming Summit, and subscribe to this podcast so as not to miss a single episode. Copyright © 2025 by APPLY Synergies, LLC | All Rights Reserved.

Richard Bonneau from Genentech on Drug Discovery, Computational Sciences and Machine Learning

Health and Explainable AI Podcast

Play Episode Listen Later Dec 18, 2025 30:27

Richard Bonneau, Vice President of Machine Learning for Drug Discovery at Genentech and Roche, provides Pitt's HexAI podcast host, Jordan Gass-Pooré, with an insider view on how his team is fundamentally changing and accelerating how new drug candidate molecules are designed, predicted, and optimized.Geared for students in computational sciences and hybrid STEM fields, the episode introduces listeners to uses of AI and ML in molecular design, the biomolecular structure and structure-function relationships that underpin drug discovery, and how distinct teams at Genentech work together through an integrated computational system.Richard and Jordan use the opportunity to touch on how advances in the molecule design domain can inspire and inform advances in computational pathology and laboratory medicine. Richard also delves into the critical role of Explainable AI (XAI), interpretability, and error estimation in the drug design-prototype-test cycle, and provides advice on domain knowledge and skills needed today by students interested in joining teams like his at Genentech and Roche.

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PulseCast: Highlights in Nonmalignant Blood Disorders From the 2025 ASH Annual Meeting

Play Episode Listen Later Dec 18, 2025 17:39

In this episode, Hanny Al-Samkari, MD, gives his thoughts on 5 key presentations from ASH 2025, and provides perspectives on the clinical implications of these data for patients with nonmalignant hematologic disorders such as ITP and vWD, including: LBA-2: Primary results from VAYHIT2, a randomized, double-blind, phase III trial of ianalumab plus eltrombopag vs placebo plus eltrombopag in patients with primary immune thrombocytopenia (ITP) who failed first-line corticosteroid treatmentAbstract 844: Secondary analysis results from VAYHIT3, a phase II study of ianalumab in patients with primary immune thrombocytopenia previously treated with at least 2 lines of therapyAbstract 5: Deciphering the dilemma: intravenous (IV) iron use in iron deficiency anemia during acute infectionsAbstract 308: Subcutaneous, every-4-week maintenance dosing of a novel protein S antibody is well tolerated and substantially reduces bleeding rates: results from a phase I/II multidose study of VGA039 in patients with von Willebrand diseaseAbstract 841: Immune thrombocytopenia in patients treated with immune checkpoint inhibitorsPresenter:Hanny Al-Samkari, MDThe Peggy S. Blitz Endowed Chair in Hematology/OncologyCo-Director, Hereditary Hemorrhagic Telangiectasia Center of ExcellenceMassachusetts General HospitalAssociate Professor of MedicineHarvard Medical SchoolBoston, MassachusettsContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program:https://bit.ly/48Ye45N Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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FDA Approvals and Global Biotech Innovations

Play Episode Listen Later Dec 17, 2025 10:06

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant updates that are shaping the future of healthcare, patient care, and drug development.The U.S. Food and Drug Administration has been particularly active recently, granting Johnson & Johnson a National Priority Review Voucher for its multiple myeloma drug combination. This move highlights the importance of J&J's treatment in addressing unmet needs within oncology, a field continuously striving for innovative solutions. These vouchers expedite the review process, reflecting a broader commitment to accelerating the availability of critical therapies for patients who need them most.Continuing with regulatory advancements, AstraZeneca and Daiichi Sankyo's Enhertu, in combination with Roche's Perjeta, has gained FDA approval as a first-line treatment for unresectable or metastatic HER2-positive breast cancer. This breakthrough is supported by late-stage study results demonstrating a 44% reduction in disease progression or death compared to standard care. The approval signifies not only progress in breast cancer therapeutics but also underscores the potential benefits of strategic collaborations in drug development. Such partnerships are increasingly vital as they aim to optimize therapeutic efficacy through shared expertise and resources.In contrast to these advancements, Pfizer is facing financial recalibrations with projected revenues for 2026 estimated to decline due to diminishing COVID-19 vaccine sales and patent expirations. This situation reflects broader industry challenges as companies navigate post-pandemic market dynamics and patent cliffs, forcing reevaluations of long-term strategies.On another front, Gilead Sciences continues to push boundaries in HIV treatment with a promising single-tablet regimen combining bictegravir and lenacapavir. This innovation targets underserved segments within the HIV market, offering streamlined treatment options that could enhance patient adherence and outcomes significantly.Shifting focus to obesity management, Novo Nordisk's oral semaglutide is emerging as a highly anticipated medication among primary care providers. This trend highlights a growing preference for oral GLP-1 therapies as convenient alternatives to injectable formulations, marking a shift in how obesity—a major public health concern—is managed.The importance of regulatory compliance remains evident as Novo Nordisk received an FDA warning letter concerning manufacturing issues at an Indiana site previously owned by Catalent. This incident underscores the necessity for rigorous quality control in pharmaceutical manufacturing, which can have far-reaching implications on operational dynamics and supply chains.The FDA is also pioneering efforts to incorporate real-world evidence into medical device submissions by opening pathways for extensive deidentified datasets from sources like national cancer registries and electronic health records. This policy shift aims to integrate diverse data sources into the evidentiary foundation for medical device evaluations, potentially fostering innovation within this sector.In line with collaborative efforts, Genentech has partnered with Caris Life Sciences in a multi-year agreement valued at up to $1.1 billion, emphasizing the strategic importance of integrating diagnostic advancements with therapeutic developments to achieve precision medicine goals.Meanwhile, Yarrow Bioscience has acquired an autoimmune thyroid disease drug from China's Gensci, exemplifying a growing trend of cross-border collaborations aimed at leveraging global innovation ecosystems to address diverse therapeutic areas. This acquisition is part of a $1.37 billion deal, reinforcing the globalization of biotech partnerships as companies seek access to novel therapeutics andSupport the show

PulseCast: Highlights in Leukemias From the 2025 ASH Annual Meeting

Journal of Clinical Oncology (JCO) Podcast

Play Episode Listen Later Dec 17, 2025 22:20

In this podcast episode, Amir T. Fathi, MD, reviews data from select presentations in leukemias at the ASH 2025 Annual Meeting, and provides perspectives on the clinical implications of these data for patients with acute myeloid leukemia (AML) or chronic myeloid leukemia (CML), including:Abstract 6: Phase II PARADIGM trial of azacitidine and venetoclax vs conventional intensive chemotherapy for fit patients with newly diagnosed AMLAbstract 47: Phase I/II SAVE trial of revumenib plus decitabine/cedazuridine and venetoclax in the cohort of patients with newly diagnosed AMLAbstract 766: Phase Ib KOMET-007 trial of ziftomenib in combination with venetoclax and azacitidine in newly diagnosed NPM1-mutant AMLAbstract 654: Phase I/II VICEROY trial of venetoclax and azacitidine + gilteritinib in patients with newly diagnosed FLT3-mutated AML ineligible for intensive induction chemotherapyAbstract 903: 3-Yr Update of the phase II FASCINATION trial of asciminib and conventional BCR::ABL1 inhibitors in newly diagnosed CMLAbstract 906: Phase II ASC2ESCALATE trial of asciminib in patients with chronic-phase CML after 1 prior TKIPresenter:Amir T. Fathi, MDDirector, Leukemia ProgramMassachusetts General HospitalAssociate Professor of MedicineHarvard Medical SchoolBoston, MassachusettsContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program:https://bit.ly/48Ye45N Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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Revolutionizing bioanalysis with high-resolution mass spec

Data in Biotech

Play Episode Listen Later Dec 15, 2025 32:31

In this episode of Data in Biotech, host Ross Katz sits down with Eshani Galermo, Staff Scientist at SCIEX, to explore the next generation of mass spectrometry in pharma and biopharma. Eshani explains how innovations like the ZenoTOF 8600 are redefining sensitivity, selectivity, and workflow efficiency in bioanalytical chemistry. Discover how high-resolution accurate mass (HRAM) systems are unlocking new capabilities in drug discovery, clinical studies, and regulatory science. What you'll learn in this episode: >> Why traditional mass spectrometry falls short in modern bioanalysis >> How the ZenoTOF 8600 enhances sensitivity and reduces sample volume needs >> The role of high-resolution systems in detecting complex drug metabolites >> How automation tools are streamlining workflows for bioanalytical scientists >> The complementary role of AI and ML in mass spec data analysis Meet our guest Eshani Galermo is a Staff Scientist at SCIEX, where she leads global strategic marketing initiatives for pharma and biopharma quant applications. With deep expertise in bioanalytical chemistry and mass spectrometry, she has held multiple scientific roles across SCIEX, Emery Pharma, and Genentech. About the host Ross Katz is Principal and Data Science Lead at CorrDyn. Ross specializes in building intelligent data systems that empower biotech and healthcare organizations to extract insights and drive innovation. Connect with Our Guest: Sponsor: CorrDyn, a data consultancyConnect with Eshani Galermo on LinkedIn Connect with Us: Follow the podcast for more insightful discussions on the latest in biotech and data science.Subscribe and leave a review if you enjoyed this episode!Connect with Ross Katz on LinkedIn Sponsored by… This episode is brought to you by CorrDyn, the leader in data-driven solutions for biotech and healthcare. Discover how CorrDyn is helping organizations turn data into breakthroughs at CorrDyn.

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JCO at 2025 ASH: Pirtobrutinib in Untreated CLL

Play Episode Listen Later Dec 9, 2025 20:17

JCO Editor-in-Chief Dr. Jonathan Friedberg is joined by colleagues Dr. Jennifer Woyach, Dr. Wojciech Jurczak, and Dr. Matthew Davids to discuss simultaneous publications presented at ASH 2025 on pertibrutinib, a new upfront treatment option for patients with chronic lymphocytic leukemia. TRANSCRIPT The disclosures for guests on this podcast can be found in the show notes. Dr. Jonathan Friedberg: I'm Jonathan Friedberg, editor of Journal of Clinical Oncology, and welcome to JCO After Hours, where we are covering two manuscripts that were presented at the American Society of Hematology meeting 2025 in Orlando, Florida. I am delighted to be joined by colleagues on this call to discuss these pivotal manuscripts which cover the topic of pirtobrutinib, a new upfront treatment option for patients with chronic lymphocytic leukemia. I will first just introduce our guests, Dr. Woyach. Dr. Jennifer Woyach: Hi, my name is Jennifer Woyach. I am from the Ohio State University. Dr. Wojciech Jurczak: Hello, I am Wojciech Jurczak, working at the National Research Institute of Oncology in Krakow, Poland. Dr. Matthew Davids: Hi, I am Matthew Davids from Dana-Farber Cancer Institute in Boston. Dr. Jonathan Friedberg: We are going to start by just learning a little bit about these two trials that were both large, randomized phase 3 studies that I think answered some definitive questions. We will start with your study, Jennifer. If you could just describe the design of your study and the patient population. Dr. Jennifer Woyach: Absolutely. So this is the BRUIN CLL-314 study, and this is a phase 3 randomized trial of pirtobrutinib versus ibrutinib in patients with CLL or SLL who had not previously been treated with a covalent BTK inhibitor. The patients were both treatment-naive and relapsed/refractory, about one-third of the patients treatment-naive, the rest relapsed/refractory, and they were stratified based upon 17p deletion and the number of prior lines of therapy. The primary objective was looking at non-inferiority of overall response rate over the entire treated population as well as the relapsed/refractory patient population. Key secondary objectives included progression-free survival in the intention-to-treat and the smaller relapsed/refractory and treatment-naive populations. Dr. Jonathan Friedberg: And just comment a little bit on the risk of the patients. Dr. Jennifer Woyach: This study was fairly typical of this cohort of patients. Within the relapsed/refractory patient population, there was a median of one prior line of therapy in each of the groups, up to nine prior lines of therapy in the patients included on the study. For the overall cohort, about two-thirds of the patients were IGHV unmutated, about 15% had 17p deletion, 30% had TP53 mutations, and about 35% to 40% had a complex karyotype, which is three or more abnormalities. Dr. Jonathan Friedberg: And what were your findings? Dr. Jennifer Woyach: Regarding the primary outcome, which is the focus of the publication, we did find that pirtobrutinib was indeed non-inferior and actually superior to ibrutinib for overall response rate throughout the entire patient population and in both the relapsed/refractory and treatment-naive cohorts. PFS is a little bit immature at this time but is trending towards also being significantly better in pirtobrutinib-treated patients compared with ibrutinib-treated patients. Probably most significantly, we found this to be the case in the treatment-naive cohort where there was a striking trend to an advantage of pirtobrutinib versus ibrutinib. Dr. Jonathan Friedberg: And the follow-up that you have on that progression-free survival? Dr. Jennifer Woyach: So we have about 18 months follow-up on progression-free survival. Dr. Jonathan Friedberg: The second study, Wojciech, can you just go through the design and patient population that you treated? Dr. Wojciech Jurczak: Thank you, Dr. Friedberg, for this question. So the BRUIN CLL-313 study was, in fact, the first phase 3 study with pirtobrutinib in exclusively untreated CLL patients. It was a randomized study where we challenged pirtobrutinib versus bendamustine-rituximab. At the time we designed the protocol, bendamustine-rituximab was an option as a standard of care, and Bruton tyrosine kinase monotherapy was used far more commonly than nowadays. The primary target of the study was progression-free survival. We took all untreated patients except for those with 17p deletions. Therefore, it is a good representation for intermediate risk. We had about 60% of the population, 56 to be precise, which was unmutated, evenly distributed into two treatment arms. 17p deleted cases were excluded, but we had about 7% and 8% of TP53 mutated patients as well as about 11% and 7%, respectively, in the pirtobrutinib and bendamustine-rituximab arm of patients with complex karyotype. The progression-free survival was in favor of pirtobrutinib and was assessed by an independent review committee. What is important is that the progression-free survival of the bendamustine-rituximab arm was actually similar to the other studies addressing the same questions, like the comparison with ibrutinib in the ALLIANCE study or zanubrutinib in the SEQUOIA study. What was different was the hazard ratio. In our study, it was 0.20. It was one of the longest effect sizes noted in the frontline BTK study. It represented an 80% reduction in progression-free survival or death. If we compare it to ibrutinib or zanubrutinib, it was 0.39 and 0.42 respectively. Presumably, this great effect contributed towards a trend of overall survival difference. Although survival data are not mature enough, there is a clear trend represented by three patients we lost in the pirtobrutinib arm versus 10 patients lost in the bendamustine-rituximab arm. This trend in overall survival is becoming statistically significant despite the fact that there was a possibility of crossover, and effectively 52.9 patients, which means 18 out of 34 patients relapsing in the bendamustine-rituximab arm, were treated by pirtobrutinib. Dr. Jonathan Friedberg: I am going to turn it over to Matt. The question is: why study pirtobrutinib in this patient population? And then with these two studies, how do you find the patients that were treated, are they representative of people who you see? And do you see this maybe being approved and more widely available? Dr. Matthew Davids: I think in terms of the first question, why study this in a frontline population, we have seen very impressive data with pirtobrutinib in a very difficult-to-treat population of CLL patients. This was from the original BRUIN phase 1/2 study where most of the patients had at least two or three lines of therapy, often both a covalent BTK inhibitor and the BCL2 inhibitor venetoclax, and yet they were still responding to pirtobrutinib. The drug was also very well tolerated in that early phase experience. And actually, we have seen phase 3 data from the BRUIN 321 study comparing pirtobrutinib to bendamustine and rituximab in a relapse population as well. So I think that really motivated these studies to look at pirtobrutinib as a first therapy. You know, often in other cancers of course, we want to use our best therapy first, and I think these studies are an initial step at looking at that. In terms of the second question around the patient population, these are pretty representative patient populations, I would say, for most frontline CLL studies. We see patients who are a bit younger and fitter than sort of the general population of CLL patients who are treated in clinical practice, and I think that is true here as well. Median age in the sort of mid-60s here is a bit younger than the typical patients we are treating in practice. But that is not different from other CLL frontline studies that we have seen recently, so I think it makes it a little bit easier as we kind of think across studies to feel comfortable that these are relatively similar populations. Dr. Jonathan Friedberg: How do you see this either getting regulatory approval or potentially being used compared to current standard of care options? Dr. Matthew Davids: So my understanding is that both of these trials were designed with registrational intent in the frontline setting, and they are both positive studies. That is certainly very encouraging in terms of the potential for an approval here. We have seen in terms of the FDA recently some concerns around the proportion of patients who are coming from North America, and my understanding is that is relatively low on these two studies. But nonetheless, the datasets are very impressive, and so I think it is certainly supportive of regulatory approval for frontline pirtobrutinib. Dr. Jonathan Friedberg: I will ask Jennifer a question. The control arm in your study was ibrutinib, and I think many in the audience may recognize that newer, second-generation BTK inhibitors like acalabrutinib and zanubrutinib are more frequently used now if monotherapy is decided. How do you respond to that, and how would you put your results in your pirtobrutinib arm in context with what has been observed with those agents? Dr. Jennifer Woyach: Yeah, that is a great question. Even though in the United States we are predominantly using acalabrutinib or zanubrutinib when choosing a monotherapy BTK inhibitor, this is actually not the case throughout the entire world where ibrutinib is still used very frequently. The head-to-head studies of both acalabrutinib and zanubrutinib compared to ibrutinib have shown us pretty well what the safety profile and efficacy profile of the second-generation BTK inhibitors is. So even though we do not have a head-to-head study of acalabrutinib or zanubrutinib versus pirtobrutinib, I think, given the entirety of data that we have with all of the covalent BTK inhibitors, I think we can safely look at the pirtobrutinib arm here, how the ibrutinib arm compares or performs in context with those other clinical trials. And though we really can not say anything about pirtobrutinib versus acalabrutinib or zanubrutinib, I think we can still get a good idea of what might be the clinical scenarios in which you might want to choose pirtobrutinib. Dr. Jonathan Friedberg: And Wojciech, do you agree with that? Obviously, I think you have acknowledged that chemoimmunotherapy is rarely used anymore as part of upfront treatment for CLL. So, I guess a similar question. If you were to put the pirtobrutinib result in your study in context with, I guess, more contemporary type controls, would you agree that it is competitive? Dr. Wojciech Jurczak: Well, I think that that was the last study ever where bendamustine-rituximab was used as a comparator arm. So we should notice that smashing difference. Because if we look at the progression-free survival at two years, we have 93.4% in pirtobrutinib arm versus 70.7% in bendamustine-rituximab arm. Bendamustine-rituximab arm did the same as in the other trials, like ALLIANCE or SEQUOIA. Pirtobrutinib did exceptionally well, as pirto is not just the very best BTK inhibitor overcoming the resistance, but perhaps even more important for the first line, it is very well tolerated and is a very selective drug. Now, if we look at treatment-related adverse events, the discontinuation rate, they were hardly ever seen. If we compared the adverse events in exposure-adjusted incidence, literally all adverse events were two or three times higher in bendamustine-rituximab arm except for the bleeding tendency, which however was predominantly in CTCAE grade 1 and 2 with just 0.7% of grade 3 hemorrhage. Therefore, I think that we should actually put the best and the safest drugs upfront if we may, and pirtobrutinib is, or should be, the first choice if we choose monotherapy. Now, I understand that we are not presenting you the data of pirtobrutinib in combination with anti-CD20 or with BCL2 inhibitors, but that is to come. Dr. Jonathan Friedberg: Matt, how would you envision, were regulatory approval granted and this were an option, using this in the upfront patient population? Is there anybody who you would preferentially use this or start on this treatment? Or would this be something that you would tend to reserve for second line? Dr. Matthew Davids: So I would say that in general for most of my patients who would want to start with a continuous BTK inhibitor, I would still use a covalent BTK inhibitor, and I say that for a couple of reasons despite the very promising data from these studies. The first is that the follow-up for both of these phase 3 trials is still quite short, in the range of a median 18 to 24 months. And we know that CLL is a marathon, not a sprint, and these patients are going to probably be living for a very long time. And we do have much longer follow-up from the covalent BTK inhibitors, median of 10-year follow-up with ibrutinib and five to six years with zanubrutinib and acalabrutinib respectively. And you know, I do not think that the pirtobrutinib is going to fall off a cliff after two years, but on the other hand, I think there is a lot of value to long-term data in this disease, and that is why I think for most of my patients I would stick with covalent BTK inhibitors. But the other important factor that we need to consider is patients who are younger and may have many different CLL treatments over the years. We have to be very careful, I think, about how we sequence these drugs. We know right now that we can start with covalent BTK inhibitors and then subsequently patients will respond well to the non-covalent inhibitor pirtobrutinib in later lines of therapy. But right now we do not have prospective data the other way around. So how will the patients on these studies who progress on pirtobrutinib respond to covalent BTK inhibitors? We do not know yet. There have not been a lot of progression events, which is great, but we would like to see some data in that respect to feel more comfortable with that sequence. Now, I do think that particularly for older patients and those who have significant cardiovascular comorbidities, if they wanted to go on a continuous BTK inhibitor, I do think these data really strongly support using pirtobrutinib as the BTK inhibitor of choice in that population. In particular, the cardiovascular risks with pirtobrutinib seem to be quite low. I was very struck in the comparison with BR that the rate of AFib was equivalent between the two arms of the study. And that is really the first time we have seen that with any of these BTK inhibitors, no elevated risk of AFib in a randomized study. I think that is the population where it will get the most traction first, is the upfront, sort of older patient with significant cardiovascular comorbidities. And as the data from these studies mature, I think that we will start to see more widespread use of pirtobrutinib in the frontline setting. Dr. Jonathan Friedberg: Jennifer, I am just curious if you have any personal experience or heard anecdotally about after progression on pirtobrutinib the use of other BTK inhibitors and whether there is a growing experience there. Dr. Jennifer Woyach: I do not think that there is much clinical experience, you know, as Matt alluded to, it certainly has not been tested yet. There has been some data in relapsed CLL suggesting that in people who have resistance mutations to covalent BTK inhibitors after treatment with pirtobrutinib, sometimes those mutations go away. I think most of us are concerned that they are probably not actually gone but maybe in compartments that we just have not sampled, suggesting that sort of approach where you might sequence a covalent inhibitor after a non-covalent in somebody who had already been resistant probably would not work that well. But, you know, in this setting where people had never been exposed to a covalent BTK inhibitor before, we really have no idea what the resistance patterns are going to be like. We assume they will be the same as what we have seen in relapsed CLL, but I think we just need some longer follow-up to know for sure. Dr. Wojciech Jurczak: If I may confront Dr. Davids about the use of covalent BTK inhibitors upfront, well, I think that we should abandon the idea of using the first and the second and the third generation, at least if we don't have medical lines. If we endlessly block the same pathway, it is not going to be effective. So if pirtobrutinib gets approval in first, second line, we do not necessarily have to use it in the first line. I am not here in a position to defend that we should treat patients with pirtobrutinib upfront and not BCL2 time-limited regimen. However, the way I look at CLL patients when choosing therapy is not just how should I treat them now, but what would be the best regimen in 5, 10 years if I have to re-treat them. And in some instances, the idea may be that in this setting we would like to have a BTK inhibitor upfront to have a BCL2 inhibitor later to make it time-limited. Although I understand and I agree with Matthew that if we have an elderly, fragile population, then the charm of having a drug taken once a day in a tablet with literally few cardiovascular adverse events might be an option. Dr. Jonathan Friedberg: And I will give Matt the last word whether he wants to respond to that, and also just as a forward-looking issue, I know both investigators have implied that there will be future studies looking at combinations with pirtobrutinib, and if you have any sense as to what you would be looking for there. Dr. Matthew Davids: The field really is heading toward time-limited therapy for most patients, I would say. There is a bit of a discrepancy right now in the field between sort of what we are doing in academic practice and what is done sort of more widely in community practice. And so right now we are going to see evolving datasets comparing these approaches. We are already seeing data now from the CLL17 study with ibrutinib comparing continuous to time-limited venetoclax-based therapy, and we are seeing similar efficacy benefits from these time-limited therapies without the need for continuous treatment. And so that is where I think some of the future studies with pirtobrutinib combining it with venetoclax and other partners are so important. Fortunately, several of these studies are already ongoing, including a phase 3 trial called CLL18, which is looking at pirtobrutinib with venetoclax, comparing that to venetoclax and obinutuzumab. So I am optimistic that we are going to be developing these very robust datasets where we can actually use pirtobrutinib in the frontline setting as a time-limited therapy as a component of a multi-drug regimen. So far, those early data are very promising. Dr. Wojciech Jurczak: Perhaps last but not least, in a single center we have treated over 300 patients with pirtobrutinib. So eventually some of them relapsed. And I must say that our experience on BCL2 inhibitors, not just venetoclax but including sonrotoclax, are appealingly good. Therefore, by using pirtobrutinib even earlier, we do not block the efficacy of other compounds. Dr. Jonathan Friedberg: All right. Well, I want to thank all of our speakers. I also want to congratulate our two guests who presented these very influential papers at the ASH Annual Meeting, and chose to publish them in JCO, so we thank you for that, and Dr. Davids for your commentary - really appreciated. That is this episode of JCO After Hours. Thank you for your attention. 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. Disclosures Dr. Wojciech Jurczak Consulting or Advisory Role: BeiGene, Lilly, Abbvie/Genentech, Takeda, Roche, AstraZeneca Research Funding: Roche, Takeda, Janssen-Cilag, BeiGene, AstraZeneca, Lilly, Abbvie/Genentech Dr. Jennifer Woyach Consulting or Advisory Role: Pharmacyclics, Janssen, AstraZeneca, Beigene, Loxo, Newave Pharmaceutical, Genentech, Abbvie, Merck Research Funding: Company name: Janssen, Schrodinger, beone, Abbvie, Merck, Loxo/Lilly Dr. Matthew Davids Honoraria: Curio Science, Aptitude Health, Bio Ascend, PlatformQ Health, Plexus Consulting or Advisory Role: Genentech, Janssen, Abbvie, AstraZeneca, Adaptive Biotechnologies, Ascentage Pharma, BeiGene, Lilly, Bristol-Myers Squibb, Genmab, Merck, MEI Pharma, Nuvalent, Inc., Galapagos NV, Schroedinger Research Funding: Ascentage Pharma, Novartis, MEI Pharma, AstraZeneca

united states north america journal poland alliance fda ash ohio state university american society astrazeneca davids roche oncology merck sequoia janssen novartis median krakow btk bruin asco schrodinger genentech abbvie hematology bristol myers squibb wojciech takeda dana farber cancer institute afib untreated bruton pfs friedberg clinical oncology cll jco cd20 tp53 ash annual meeting sll genmab loxo bcl2 adaptive biotechnologies disclosures dr mei pharma ighv

What Challenges Will Oncologists Face in 2026?

PeerView Family Medicine & General Practice CME/CNE/CPE Video Podcast

Play Episode Listen Later Dec 4, 2025 22:14

Dr. Monty Pal and Dr. Jason Westin discuss the federal funding climate for cancer research and the persistent problem of drug shortages, two of the major concerns facing the oncology community in 2026. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I am your host, Dr. Monty Pal. I am a medical oncologist and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. There are always multiple challenges facing oncologists, and today, we discuss two of them that really stand out for 2026: threats to federal funding for cancer research and the persistent problem of drug shortages. I am thrilled to welcome Dr. Jason Westin, who believes that one way to meet these challenges is to get oncologists more involved in advocacy, and he will share some strategies to help us meet this moment in oncology. Dr. Westin is a professor in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center, but he actually wears a lot of hats within ASCO. He is a member of the Board of Directors and has also previously served as chair of ASCO's Government Relations Committee. And he is also one of the inaugural members of ASCO's Political Action Committee, or PAC. He has testified before Congress about drug shortages and many other issues. Dr. Westin, I am really excited to have you on the podcast today and dive into some of these elements that will really impact our community in 2026. Thanks so much for joining us today. Dr. Jason Westin: Thank you for having me. Dr. Monty Pal: You've had such a range of experience. I already alluded to you testifying before Congress. You've actually run for office before. You wear so many different hats. I'm used to checking my PubMed every other day and seeing a new paper out from you and your group, and you publish in the New England Journal [of Medicine] on practice-setting standards and the diseases that you treat. But you've also done all this work in the domain of advocacy. I can't imagine that balancing that is easy. What has sort of motivated you on the advocacy front? Dr. Jason Westin: Advocacy to me is another way to apply our skills and help more people than just those that you're sitting across from at the time. Clinical research, of course, is a tool to try and take what we know and apply it more broadly to people that you'll never meet. And advocacy, I think, can do the same thing, where you can have a conversation with a lawmaker, you can advocate for a position, and that hopefully will help thousands or maybe even more people down the road who you'd never get to directly interact with. And so, I think it's a force multiplier in the same way that research can be. And so, I think advocacy is a wonderful part of how doctors care for our patients. And it's something that is often difficult to know where to start, but once people get into advocacy, they can see that the power, the rewarding nature of it is attractive, and most people, once they get going, continue with that through the rest of their career. Dr. Monty Pal: So, I'll ask you to expand on that a little bit. We have a lot of our younger ASCO members listening to this podcast, folks that are just starting out their careers in clinical practice or academia. Where does that journey begin? How do you get to the point that you're testifying in front of Congress and taking on these bigger sort of stances for the oncology community? Dr. Jason Westin: Yeah, with anything in medicine and in our careers, you have to start somewhere. And often you start with baby steps before you get in front of a panel of senators or other high-profile engagement opportunities. But often the first setting for junior colleagues to be engaged is doing things – we call them "Hill Days" – but basically being involved in kind of low-stakes meetings where you're with a group of peers, some of whom have done this multiple times before, and can get engaged talking to members of representatives' offices, and doing so in a way where it's a natural conversation that you're telling a story about a patient in your clinic, or that you're telling a personal experience from a policy that impacted your ability to deliver optimal care. It sounds stressful, but once you're doing it, it's not stressful. It's actually kind of fun. And it's a way that you can get comfort and skill with a group of peers who are there and able to help you. And ASCO has a number of ways to do that, both at the federal level, there's the Hill Day where we each April have several hundred ASCO members travel to Capitol Hill. There's also state engagement that can be done, so-called visiting at home, when representatives from the U.S. Congress or from state legislators are back in district. You can meet with your own representatives on behalf of yourself, on behalf of your organization, and advocate for policies in a way that can be beneficial to your patients. But those initial meetings that are in the office often they're low stakes because you could be meeting not with the representative but with their staff. And that staff sometimes is as young or even younger than our junior colleagues. These sometimes can be people in their 20s, but they're often extremely knowledgeable, extremely approachable, and are used to dealing with people who are new to advocacy. But they actually help make decisions within the office. So it's not a waste of time. It's actually a super useful way to engage. So, it's that first step of anything in life. The activation energy is always high to do something new. But I'd encourage people who are listening to this podcast already having some level of interest about it to explore ways that they could engage more. Dr. Monty Pal: You know, I have to tell you, I'm going to riff on what you just said for a second. ASCO couldn't make it any easier, I think, for folks to participate and get involved. So, if you're listening to this and scratching your head and thinking, "Well, where do I begin? How do I actually sign on for that meeting with a local representative?" Go to the ASCO ACT Network website. And I'll actually talk to our producer, Geraldine, to make sure we've got a link to that somewhere associated with this podcast after it's published, Jason, but I actually keep that on my browser and it's super easy. I check in there every now and then and see if there's any new policy or legislation that ASCO, you know, is sort of taking a stance on, and it gives me some fodder for conversation with my local representatives too. I mean, it's just an awesome, awesome vehicle. I'm going to segue right from there right to the issues. So, you and I are both at academic centers. You know, I think this is something that really pervades academia and enters into implications for general clinical practice. There's been this, you know, massive sort of proposal for decreased funding to the NCI and to the NIH and so forth. Tell us what ASCO is doing in that regard, and tell us perhaps how our community can help. Dr. Jason Westin: We live in interesting times, and I think that may be an understatement x 100. But obviously investments in research are things that when you're at an academic center, you see and feel that as part of your daily life. Members of Congress need to be reminded of that because there's a lot of other competing interests out there besides investing in the future through research. And being an elected representative is a hard job. That is something where you have to make difficult choices to support this, and that may mean not supporting that. And there's lots of good things where our tax dollars could be spent. And so, I'm sympathetic to the idea that there's not unlimited resources. However, ASCO has done an excellent job, and ASCO members have led the charge on this, of stating what research does, what is the benefit of research, and therefore why should this matter to elected representatives, to their staff, and to those people that they're elected to serve. And ASCO has led with a targeted campaign to basically have that message be conveyed at every opportunity to elected representatives. And each year on Hill Day, one of the asks that we have is to continue to support research: the NCI, NIH, ARPA-H, these are things that are always in the asks to make sure that there's appropriate funding. But effectively playing offense by saying, "It's not just a number on a sheet of paper, this is what it means to patients. This is what it means to potentially your loved ones in the future if you are in the opposite situation where you're not on the legislative side, but you're in the office receiving a diagnosis or receiving a difficult piece of news." We only have the tools we have now because of research, and each breakthrough has been years in the making and countless hours spent funded through the engine of innovation: clinical research and translational research. And so ASCO continues to beat that drum. You mentioned earlier the ACT Network. Just to bring that back again is a very useful, very easy tool to communicate to your elected representatives. When you sign up on the ASCO ACT website, you get emails periodically, not too much, but periodically get emails of, "This is a way you can engage with your lawmakers to speak up for this." And as you said, Monty, they make it as easy as possible. You click the button, you type in your address so that it figures out who your elected representatives are, and then it will send a letter on your behalf after like five clicks to say, "I want you to support research. I want you to vote for this particular thing which is of interest to ASCO and by definition to members of ASCO." And so the ACT Network is a way that people listening can engage without having to spend hours and significant time, but just a few clicks can send that letter to a representative in Congress. And the question could be: does that matter? Does contacting your senator or your elected representative do anything? If all they're hearing is somebody else making a different argument and they're hearing over and over again from people that want investments in AI or investments in something else besides cancer research, whatever it is, they may think that there's a ground shift that people want dollars to be spent over here as opposed to at the NIH or NCI or in federally funded research. It is important to continue to express the need for federal funding for our research. And so, it really is important for folks to engage. Dr. Monty Pal: 100%. One of the things that I think is not often obvious to a lot of our listeners is where the support for clinical trials comes from. You know, you've obviously run the whole gamut of studies as have I. You know, we have our pharmaceutical company-sponsored studies, which are in a particular bucket. But I would say that there's a very important and critical subset of studies that are actually government funded, right? NCI-funded clinical trials. If you don't mind, just explain to our audience the critical nature of the work that's being done in those types of studies and if you can, maybe compare and contrast the studies that are done in that bucket versus perhaps the pharmaceutical bucket. Dr. Jason Westin: Both are critical, and we're privileged that we have pharma studies that are sponsored and federally funded clinical research. And I think that part of a healthy ecosystem for us to develop new breakthroughs has a need for both. The pharma sponsored studies are done through the lens of trying to get an approval for an agent that's of interest so that the pharma company can then turn around and use that outside of a clinical trial after an FDA approval. And so those studies are often done through the lens of getting over the finish line by showing some superiority over an existing treatment or in a new patient population. But they're done through that lens of kind of the broadest population and sometimes relatively narrow endpoints, but to get the approval so that then the drug can be widely utilized. Clinical trials done through cooperative groups are sometimes done to try and optimize that or to try and look at comparative things that may not be as attractive to pharma studies, not necessarily going for that initial approval, but the fine tuning or the looking at health outcomes or looking at ensuring that we do studies in representative populations that may not be as well identified on the pharma sponsored trials, but basically filling out the gaps in the knowledge that we didn't gain from the initial phase 3 trial that led to the approval. And so both are critical. But if we only do pharma sponsored trials, if we don't fund federally supported research and that dries up, the fear I have, and many others have, is that we're going to be lacking a lot of knowledge about the best ways to use these great new therapies, these new immune therapies, or in my team, we do a lot of clinical trials on CAR T-cell therapies. If we don't have federally funded research to do the important clinical studies, we'll be in the dark about the best ways to use these drugs, and that's going to be a terrible shame. And so we really do need to continue to support federal research. Dr. Monty Pal: Yeah, there are no softball questions on this podcast, but I think everybody would be hard pressed to think that you and I would come on here and say, "Well, no, we don't need as much money for clinical trials and NCI funding" and so forth. But I think a really challenging issue to tackle, and this is something we thought to ask you ahead of the podcast, is what to do about the general climate of, you know, whether it's academic research or clinical practice here that seems to be getting some of our colleagues thinking about moving elsewhere. I've actually talked to a couple of folks who are picking up and moving to Europe for a variety of considerations, other continents, frankly. The U.S. has always been a leader when it comes to oncology research and, one might argue, research in general. Some have the mindset these days that we're losing that footing a little bit. What's your perspective? Are you concerned about some of the trends that you're seeing? What does your crystal ball tell you? Dr. Jason Westin: I am highly concerned about this. I think as you said, the U.S. has been a leader for a long time, but it wasn't always. This is not something that's preordained that the world-leading clinical research and translational research will always be done in the United States. That is something that has been developed as an ecosystem, as an engine for innovation and for job development, new technology development, since World War II. That's something that through intentional investments in research was developed that the best and brightest around the world, if they could choose to go anywhere, you wanted them to come to work at universities and academic places within the United States. And I think, as you said, that's at risk if you begin to dry up the investment in research or if you begin to have less focus on being engaged in research in a way that is forward thinking, not just kind of maintaining what we do now or only looking at having private, for profit sponsored research. But if you don't have the investment in the basic science research and the translational research and the forward-thinking part of it, the fear is that we lose the advantage and that other countries will say, "Thank you very much," and be happy to invest in ways to their advantage. And I think as you mentioned, there are people that are beginning to look elsewhere. I don't think that it's likely that a significant population of researchers in the U.S. who are established and have careers and families – I don't think that we're going to see a mass exodus of folks. I think the real risk to me is that the younger, up-and-coming people in undergraduate or in graduate school or in medical school and are the future superstars, that they could either choose to go into a different field, so they decide not to go into what could be the latest breakthroughs for cancer patients but could be doing something in AI or something in a different field that could be attractive to them because of less uncertainty about funding streams, or they could take that job offer if it's in a different country. And I think that's the concern is it may not be a 2026 problem, but it could be a 2036 or a 2046 problem that we reap what we sow if we don't invest in the future. Dr. Monty Pal: Indeed, indeed. You know, I've had the pleasure of reviewing abstracts for some of our big international meetings, as I'm sure you've done in the past too. I see this trend where, as before, we would see the preponderance of large phase 3 clinical trials and practice setting studies being done here in the U.S., I'm seeing this emergence of China, of other countries outside of the U.S. really taking lead on these things. And it certainly concerns me. If I had to sort of gauge this particular issue, it's at the top of my list in terms of what I'm concerned about. But I also wanted to ask you, Jason, in terms of the issues that are looming over oncology from an advocacy perspective, what else really sort of keeps you up at night? Dr. Jason Westin: I'm quite concerned about the drug shortages. I think that's something that is a surprisingly evergreen problem. This is something that is on its face illogical that we're talking about the greatest engine for research in the world being the United States and the investment that we've made in drug development and the breakthroughs that have happened for patients all around the world, many of them happen in the United States, and yet we don't necessarily have access to drugs from the 1970s or 1980s that are cheap, generic, sterile, injectable drugs. This is the cisplatins and the vincristines and the fludarabine type medications which are not the sexy ones that you see the ads in the magazine or on TV at night. These are the backbone drugs for many of our curative intent regimens for pediatrics and for heme malignancies and many solid tumors. And the fact that that's continuing to be an issue is, in my opinion, a failure to address the root causes, and those are going to require legislative solutions. The root causes here are basically a race to the bottom where the economics to invest in quality manufacturing really haven't been prioritized. And so it's a race to the cheapest price, which often means you undercut your competitor, and when you don't have the money to invest in good manufacturing processes, the factory breaks down, there's no alternative, you go into shortage. And this has been going on for a couple of decades, and I don't think there's an end in sight until we get a serious solution proposed by our elected officials. That is something that bothers me in the ways where we know what we should be doing for our patients, but if we don't have the drugs, we're left to be creative in ways we shouldn't have to do to figure out a plan B when we've got curative intent therapies. And I think that's a real shame. There's obviously a lot of other things that are concerning related to oncology, but something that I have personally had experience with when I wanted to give a patient a CAR T-cell, and we don't have a supply of fludarabine, which is a trivial drug from decades ago in terms of the technology investments in genetically modified T-cells, to not then have access to a drug that should be pennies on the dollar and available at any time you want it is almost like the Air Force investing in building the latest stealth bomber, but then forgetting to get the jet fuel in a way that they can't use it because they don't have the tools that they need. And so I think that's something that we do need to have comprehensive solutions from our elected officials. Dr. Monty Pal: Brilliantly stated. I like that analogy a lot. Let's get into the weeds for a second. What would that proposal to Congress look like? What are we trying to put in front of them to help alleviate the drug shortages? Dr. Jason Westin: We could spend a couple hours, and I know podcasts usually are not set up to do that. And so I won't go through every part. I will direct you that there have been a couple of recent publications from ASCO specifically detailing solutions, and there was a recent white paper from the Senate Finance Committee that went through some legislative solutions being explored. So Dr. Gralow, ASCO CMO, and I recently had a publication in JCO OP detailing some solutions, more in that white paper from the Senate Finance. And then there's a working group actually going through ASCO's Health Policy Committee putting together a more detailed proposal that will be published probably around the end of 2026. Very briefly, what needs to happen is for government contracts for purchasing these drugs, there needs to be an outlay for quality, meaning that if you have a manufacturing facility that is able to deliver product on time, reliably, you get a bonus in terms of your contract. And that changes the model to prioritize the quality component of manufacturing. Without that, there's no reason to invest in maintaining your machine or upgrading the technology you have in your manufacturing plant. And so you have bottlenecks emerge because these drugs are cheap, and there's not a profit margin. So you get one factory that makes this key drug, and if that factory hasn't had an upgrade in their machines in 20 years, and that machine conks out and it takes 6 months to repair or replacement, that is an opportunity for that drug to go into shortage and causes a mad dash for big hospitals to purchase the drug that's available, leaving disparities to get amplified. It's a nightmare when those things happen, and they happen all the time. There are usually dozens, if not hundreds, of drugs in shortage at any given time. And this has been going on for decades. This is something that we do need large, system-wide fixes and that investment in quality, I think, will be a key part. Dr. Monty Pal: Yeah, brilliantly said. And I'll make sure that we actually include those articles on the tagline for this podcast as well. I'll talk to our producer about that as well. I'm really glad you mentioned the time in your last comment there because I felt like we just started, but in fact, I think we're right at our close here, Jason, unfortunately. So, I could have gone on for a couple more hours with you. I really want to thank you for these absolutely terrific insights and thank you for all your advocacy on behalf of ASCO and oncologists at large. Dr. Jason Westin: Thank you so much for having me. I have enjoyed it. Dr. Monty Pal: Thanks a lot. And many thanks to our listeners too. You can find more information about ASCO's advocacy agenda and activities at asco.org. Finally, if you value the insights that you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Thanks so much. ASCO Advocacy Resources: Get involved in ASCO's Advocacy efforts: ASCO Advocacy Toolkit Crisis of Cancer Drug Shortages: Understanding the Causes and Proposing Sustainable Solutions, JCO Oncology Practice 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. Monty Pal  @montypal  Dr. Jason Westin @DrJasonWestin Follow ASCO on social media:     @ASCO on X ASCO on Bluesky   ASCO on Facebook     ASCO on LinkedIn     Disclosures:    Dr. Monty Pal:   Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview  Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical  Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis  Dr. Jason Westin: Consulting or Advisory Role: Novartis, Kite/Gilead, Janssen Scientific Affairs, ADC Therapeutics, Bristol-Myers Squibb/Celgene/Juno, AstraZeneca, Genentech/Roche, Abbvie, MorphoSys/Incyte, Seattle Genetics, Abbvie, Chugai Pharma, Regeneron, Nurix, Genmab, Allogene Therapeutics, Lyell Immunopharma Research Funding: Janssen, Novartis, Bristol-Myers Squibb, AstraZeneca, MorphoSys/Incyte, Genentech/Roche, Allogene Therapeutics

united states tv director university ai europe china los angeles challenges board medicine congress world war ii air force advocacy fda pac clinical capitol hill cart astrazeneca nih monty merck new england journal novartis lymphoma accommodations asco oncologists pubmed genentech abbvie bristol myers squibb regeneron senate finance committee nci myeloma texas md anderson cancer center political action committees ipsen arpa h hill day genmab crispr therapeutics osel senate finance government relations committee seattle genetics janssen scientific affairs transcript dr

Bruce E. Sands, MD, MS - Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis

Play Episode Listen Later Dec 3, 2025 60:50

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/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis 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 educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

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Bruce E. Sands, MD, MS - Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis

PeerView Clinical Pharmacology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Dec 3, 2025 60:50

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/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis 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 educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

Bruce E. Sands, MD, MS - Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis

PeerView Internal Medicine CME/CNE/CPE Video Podcast

Play Episode Listen Later Dec 3, 2025 60:50

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/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis 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 educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

Bruce E. Sands, MD, MS - Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis

PeerView Internal Medicine CME/CNE/CPE Audio Podcast

Play Episode Listen Later Dec 3, 2025 60:50

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/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis 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 educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

TURN BIAS INTO BOLDNESS AND DECISIONS INTO IMPACT WITH NEUROSCIENCE

Alloutcoach Tim

Play Episode Listen Later Nov 20, 2025 32:25

Sandra Walker is CEO, Viacern Group, and Venture Partner at Hard Climate, a seasoned and inspirational pharma and biotech executive leading Commercial, Medical Operations and Excellence, Government Affairs, Global Strategy and Product Planning at companies such as Genentech, Roche, Eli Lilly and Abbvie. She delivered a state-of-the-art, candid, and intriguing keynote presentation that forces you to reflect on the language and process you use to make decisions in medicine, healthcare, and how you can challenge your current approaches and biases using neuroscience-based practical, real-world solutions to make bolder decisions with evidence to drive innovation forward.3:10 Speaker Introduction4:12 Turning Innovation into OutcomesThree Common recurring Decision PatternsExplaining Biases in Decision-makingPractical Solutions to Transform DecisionsThe Bolder WayDecision Audit5:56 Three Invisible Decision Patterns6:37 Status Quo Bias8:51 Countermoves You Can Use vs Status Quo Bias9:29 Confirmation Bias11:54 10-Minute Challenge Round To use Vs. Confirmation Bias 13:09 Completion Bias - Relief of Feeling Done16:30 Explaining the Brain under Pressure with Neuroscience 18:50 How to Quiet the Noise in BiasLabel the state – identify the bias, problem, riskExternalize thinking – move ideas onto paper to createpublic reasoningTeach the cheerleader to celebrate learning not justfinishing.Train for Learning not Finishing21:01 The Bolder Way - 6 steps to turn Awareness into ActionB - Bias and Blind Spots visualization (see the invisible)O - Observe: Disciplined CuriosityL - Learn: Broadened PerspectivesD - Decide with clarity and transparencyE - Empower: Trust with ContextR - Recalibrate: Boldness into Learning27:11 Bolder Way Framework Aligned to the Scientific Method 28:02 Language You Use is Key to Decision Outcome28:38 The Decision Audit to Deliver Clarity in 5 Minutes31:09 How Speed of Decision Impacts the Outcome

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Health UnaBASHEd: Origins of Modern Biotech Finance with Dennis Purcell, Aisling Capital

HealthcareNOW Radio - Insights and Discussion on Healthcare, Healthcare Information Technology and More

Play Episode Listen Later Nov 15, 2025 26:36

On this episode Gil Bashe and Gregg Masters engage Dennis Purcell, founding partner of Aisling Capital and architect of the original H&Q Life Sciences Conference that became the go to industry standard J.P. Morgan Healthcare Investor Conference. Purcell reflects on four decades of biotech investing—from Genentech's 1980 IPO to today's GLP-1 metabolic revolution. He unpacks capital cycles, the role of purpose-based investors, and the moral call to redirect innovation toward chronic disease and global health equity. To stream our Station live 24/7 visit www.HealthcareNOWRadio.com or ask your Smart Device to “….Play Healthcare NOW Radio”. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen

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The Brutal Truth About Biotech: Why $2B Per Drug Is Killing Innovation

a16z

Play Episode Listen Later Nov 14, 2025 62:23

Two venture capitalists dissect why biotech burns billions while China runs trials in weeks—and why the next Genentech won't look anything like the last one. Elliot Hershberg reveals the "three horsemen" strangling drug development as costs explode to $2.5 billion per approval, while Lada Nuzhna exposes how investigator-initiated trials in Shanghai are rewriting the competitive playbook faster than American founders can file INDs. When the infrastructure that built monoclonal antibodies becomes the commodity threatening to hollow out an entire industry, the only path forward demands inventing medicines that are literally impossible to make without tools that don't exist yet—and they're betting everything on which approach survives. Resources:Follow Jorge on X: https://x.com/JorgeCondeBioFollow Lada on X: https://x.com/ladanuzhnaFollow Elliot on X: https://x.com/ElliotHershbergFollow Erik on X: https://x.com/eriktorenberg Stay Updated: If you enjoyed this episode, be sure to like, subscribe, and share with your friends!Find a16z on X: https://x.com/a16zFind a16z on LinkedIn: https://www.linkedin.com/company/a16zListen to the a16z Podcast on Spotify: https://open.spotify.com/show/5bC65RDvs3oxnLyqqvkUYXListen to the a16z Podcast on Apple Podcasts: https://podcasts.apple.com/us/podcast/a16z-podcast/id842818711Follow our host: https://x.com/eriktorenbergPlease note that the content here is for informational purposes only; should NOT be taken as legal, business, tax, or investment advice or be used to evaluate any investment or security; and is not directed at any investors or potential investors in any a16z fund. a16z and its affiliates may maintain investments in the companies discussed. For more details please see a16z.com/disclosures. Stay Updated:Find a16z on XFind a16z on LinkedInListen to the a16z Podcast on SpotifyListen to the a16z Podcast on Apple PodcastsFollow our host: https://twitter.com/eriktorenberg Please note that the content here is for informational purposes only; should NOT be taken as legal, business, tax, or investment advice or be used to evaluate any investment or security; and is not directed at any investors or potential investors in any a16z fund. a16z and its affiliates may maintain investments in the companies discussed. For more details please see a16z.com/disclosures. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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#136 - Food Allergy Treatments: What to Ask Your Doctor

The Itch: Allergies, Asthma & Immunology

Play Episode Listen Later Nov 13, 2025 37:29

Avoidance has long been the standard for managing food allergies. But new options, such as oral immunotherapy (OIT) and biologic medications like Xolair (omalizumab), are changing the landscape. With more choices available, many patients and parents are wondering how to start the conversation with their allergist and what questions to ask. Kortney and Dr. Payel Gupta talk with Dr. Shahzad Mustafa, a board-certified allergist and immunologist, about how patients can navigate today's food allergy treatments with confidence. Together, they explore what to consider before starting OIT or Xolair, how to set realistic expectations, and why strict avoidance is still the right choice for many families. What we cover about food allergy treatment options: Food Allergy Avoidance: Why it remains an effective and valid approach for many, and how to make it work in daily life, including the nuances that make every case unique. Oral Immunotherapy (OIT): What it involves, who it's best suited for, and what families should know about time, cost, and safety. Xolair (omalizumab): How this injection therapy works to reduce reactions from accidental exposures and what it doesn't do. Setting expectations: How to talk with your allergist about your goals, quality of life, and what “success” really looks like. More episodes about food allergies Ep. 129: Omalizumab for Multiple Food Allergies – The OUtMATCH Trial Ep. 98: Food Allergy Treatment and Management More resources about food allergies Food Allergy Treatment & Management ___ Made in partnership with The Allergy & Asthma Network. Thanks to Genentech for sponsoring today's episode. This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

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How Nimbus CEO Abbas Kazimi Builds Resilient Pipelines Through Culture, Rigor & Smart Bets

Biotech 2050 Podcast

Play Episode Listen Later Nov 13, 2025 42:37

Synopsis: Nimbus Therapeutics CEO Abbas Kazimi walks Alok Tayi through the company's evolving pipeline and playbook for choosing the right risks in a noisy biotech environment. From Werner helicase for MSI-high cancers to a highly selective SIK2 program and GLP-1–adjacent strategies focused on body composition, Abbas details how Nimbus balances rigor, speed, and capital efficiency. He shares candid lessons from pausing and later resurrecting AMPK beta in partnership with Eli Lilly, the decision to remain modality-agnostic but small-molecule-centric, and the importance of knowing when not to chase the latest fad. Throughout, Abbas returns to a consistent theme: success at Nimbus comes from disciplined target selection, deep collaboration, and a culture that empowers teams to make hard calls in service of patients rather than headlines. Biography: Abbas Kazimi is the Chief Executive Officer of Nimbus Therapeutics. Previously, he served as Chief Business Officer, leading the company's strategic and corporate development efforts while overseeing business operations. Since joining Nimbus in 2014, he has helped raise over $630 million in equity financing and led transactions totaling more than $8 billion. Notably, Mr. Kazimi spearheaded the $6 billion sale of Nimbus's TYK2 program to Takeda, the $1.2 billion sale of its NASH (ACC) program to Gilead, and multiple licensing deals exceeding $1.5 billion with partners such as Genentech, Celgene/Roche, and Eli Lilly. Under his leadership, Nimbus has advanced four programs into the clinic, returned over $4 billion to investors, and continues to expand its computational drug discovery and clinical development capabilities. In 2025, Mr. Kazimi joined the board of Unnatural Products (UNP), a biotech company pioneering orally delivered macrocyclic peptides to tackle previously undruggable targets. He also serves on the Editorial Advisory Board for In Vivo magazine, a leading publication offering strategic insights and analysis of the pharmaceutical, biotechnology, medtech, and consumer health industries. Along with his family, he established the Kazimi Family Endowment for Data Science in Oncology at MD Anderson Cancer Center. This endowment reflects their personal commitment to philanthropy and their vision for revolutionizing cancer treatment through data-driven innovation. At the core of Mr. Kazimi's leadership is a deep sense of purpose—one that seeks to change the trajectory of medical diagnoses where options are limited. The ability to give patients, prescribers, and families a new outlook on life is a powerful responsibility—and one he knows the biopharmaceutical sector has the ability to fulfill. Before Nimbus, he was at Extera Partners, LLC (formerly PureTech Development, LLC), where he provided strategic advisory, supported fundraising, and executed numerous business development transactions. Earlier in his career, he was with JSB-Partners, LP, a specialized investment banking and advisory firm serving biotech and pharmaceutical companies. Mr. Kazimi holds a B.A. from the University of Texas at Austin and an M.S. from Harvard University.

#135 - Food Allergies in School: A School Nurse's Perspective

The Itch: Allergies, Asthma & Immunology

Play Episode Listen Later Nov 6, 2025 37:36

When it comes to keeping kids with food allergies safe at school, school nurses are often the quiet heroes behind the scenes. From managing allergy action plans and emergency responses to training teachers and organizing care for hundreds of students, their role is essential, but often misunderstood. Kortney and Dr. Payel Gupta sit down with Elizabeth Elliott, a school nurse and President of the Maryland Association of School Health Nurses. Liz shares what really happens inside the health room and how school nurses coordinate care for students with food allergies and asthma. Plus, why communication between families and school staff is key to keeping kids safe. After this episode, you'll have a whole new appreciation for your school nurse and a better understanding of how to partner with them to make every school day safer for kids with allergies. What we cover about food allergy management at school: The school nurse's role: How nurses bridge communication between families, teachers, and doctors to keep children with food allergies safe and included during the school day. Coordinating care: How school nurses use action plans and 504s to ensure everyone, from teachers to cafeteria staff, knows how to keep kids safe. Training and emergency preparedness: How school nurses teach staff to recognize anaphylaxis, use epinephrine, and stay calm during an emergency. Field trips, cafeterias, and bus safety: What goes into planning safe experiences beyond the classroom, and why “no-food on the bus” rules really matter. Advocating for resources: How families can support their school nurses and advocate for better funding, staffing, and allergy awareness in schools. ___ Made in partnership with The Allergy & Asthma Network. Thanks to Genentech for sponsoring today's episode. This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

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Managing Immune-Related Toxicities in Oncology