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Host Dr. Davide Soldato and Dr. Aaron Mitchell discuss the JCO article "Quality of Treatment Selection for Medicare Beneficiaries With Cancer" TRANSCRIPT Dr. Davide Soldato: Hello and welcome to JCO After Hours, the podcast where we sit down with authors from some of the latest articles published in the Journal of Clinical Oncology. I am your host, Dr. Davide Soldato, medical oncologist at Hospital San Martino in Genoa, Italy. Today, we are joined by JCO author Dr. Aaron Mitchell. Dr. Mitchell is a medical oncologist working at Memorial Sloan Kettering Cancer Center where he is also part of the Department of Epidemiology and Biostatistics. Dr. Mitchell specializes in treating genitourinary malignancy and has a research focus on improving how the healthcare system helps people with these and other cancers. So today, Dr. Mitchell will be discussing the article titled, “Quality of Treatment Selection for Medicare Beneficiaries with Cancer.” Thank you for speaking with us, Dr. Mitchell. Dr. Aaron Mitchell: Well, thank you for inviting me. I'm very glad to be here. Dr. Davide Soldato: So I just wanted to introduce the topic by asking a couple of questions, very general, about the background of the article. So basically you reported the data using the SEER-Medicare to assist to assess the determinants of optimal systemic therapies delivery and selection. So, in particular, you focused on individuals that were diagnosed with cancer who were Medicare beneficiaries and in particular were part of the low income subsidy, which is also known as LIS. So I just wanted to ask you if you could briefly explain to our listeners how this program works, and what was the rationale of the study, and if there is any element of novelty in your study compared to what was done before the study was published. Dr. Aaron Mitchell: Yeah. So that's a lot to cover, but yeah, a lot of opportunity to introduce the low income subsidy program which is a very important part of the Medicare program for prescription drugs, but often one that flies under the radar a little bit in the policy discussion. So this subsidy was created synchronously back with the Medicare Part D Program, which was created in 2006. There was some anticipation that for some high cost drugs, not all patients would be able to afford them even with the Part D program insurance as it was being created. And so they created a pathway to give an additional subsidy to some patients who had low income, who were anticipated to being at need and needing that assistance to afford high cost drugs. As the number of high cost drugs has really risen since 2006, this program has played an important role in helping patients afford drugs, especially those who need very expensive cancer drugs.  And what this program does is, once you meet the eligibility requirements, which require patients to have both quite a low income. So if you're single, that is at 135% of the federal poverty limit or below, and it also places some restrictions on assets. You also have to have low assets, so low income and low assets in order to qualify for the subsidy. But then once you do, the subsidy is really quite large. Patients who qualify for the LIS at the full subsidy level will pay about $10 per month per drug, even for specialty cancer drugs. So if you think about drugs such as those that we use to treat prostate cancer, my specialty, drugs like enzalutamide or XTANDI that run $15,000 to $20,000 per month, the out of pocket cost for a low income subsidy beneficiary is $10. So that is a huge discount. $10 isn't nothing, but even for someone with a low income, if they've got one or two cancer drugs that are at this rate, it's something that they can often afford.  This program applies to Part D cancer drugs that are prescription drugs basically. By and large, these are oral pills that patients are taking on a daily basis at home. These are the drugs that the low income subsidy program applies to. So if a patient needs a drug like that to treat their cancer, then they are able to receive it at very low cost. And what you'll see is a patient- in the studies that have been done, when a patient has low income, low enough for them to be able to qualify for this program, they then have better access to these drugs. You see increased adherence rates, you see increased prescription fill rates. And then when someone, when their income is just high enough to no longer qualify for this program, and they go back to regular Medicare Part D coverage, that's when the problems arise. So it's like as your income moves up the scale, you actually get more problems affording your cancer drugs. So that's the state of the literature so far.  And what we realize though, is that all these studies that have looked at the low income subsidy have really focused on just the Part D drugs themselves, the oral drugs. And that's certainly not all of cancer care. There is a growing number of oral drugs, but for many cancers, especially when you're talking about immunotherapy drugs or new systemic radioligand therapies, these are not Part D drugs, these are Part B drugs. And so even if you are low income and you're qualifying for this subsidy, it's not going to help you if you need a Part B drug. Yes, there are certainly a whole host of other programs and different avenues that we can get patients assistance, but some percentage of them, even though they're low income and high need, would not have assistance with a Part B drug.  So now, in coming back, the long answer to your question, our rationale was, let's look at these Part D low income subsidy patients and let's see what their access looks like, not just to the oral drugs, but to cancer care writ large. And can we study where they're fitting into the system, not only when they need oral drugs, but when they need any kind of cancer care across the board? Dr. Davide Soldato: So basically, just to summarize, it was an extension of previous literature, but specifically evaluating whether novel regimens that use, for example intravenous drugs, they were covered at the same level and whether there were any inequities in access to cancer treatment under this specific program, which is the LIS. Dr. Aaron Mitchell: Yes, I'd say that's a fair summary. Dr. Davide Soldato: Okay. So more or less, you included 9,000 patients inside of the study and 25% of them were beneficiaries of the LIS program. And you specifically looked at factors that could be associated with not receiving therapies at all, and also whether the quality of care that these patients were receiving were any different compared to those who were not part of the LIS program. So I just wanted to see if you could guide us a little bit in the results, whether you see any kind of differences when we look at access to any type of systemic therapies and whether being a part of the LIS program modified access to the drugs. Dr. Aaron Mitchell: Let me take this opportunity also to highlight a feature of our study that differentiates us a little bit from previous work that's been done. And this is around the specific definition of quality that we use. I know quality is in the title of the manuscript, but I think it's important to emphasize exactly what we mean in this study when we say quality, and it's something very specific. So our measure of quality references back to the NCCN guidelines, which I don't think our audience needs much of an introduction to that. It's the most worldwide recognized standard of care guidelines for oncology practice. And we specifically looked not only at the NCCN guidelines, but at their evidence block scoring system. So what we did was we looked not only at one set of guidelines, but we looked at guidelines across time. We looked at guidelines across our full study period, which was, give or take, 2015-2018, depending on the cancer. And we looked at each point in time to see what was the treatment regimen that was recommended by the NCCN guidelines as being preferred. Some of them make that designation, some of them don't. If there was not a designation of preferred, then we turned to the evidence blocks. And the evidence blocks, we then apply several different measures to kind of rank treatments from those that get high scores for efficacy and safety to those that get low scores for efficacy, safety and the quality of evidence. So we basically come up with a kind of a rank list of the recommended treatments at each point in time. And then we look at the ones that are the highest, we say which are the most highly recommended treatments at any given point in time. That then becomes our definition of quality treatment. And I'm saying this with air quotes, we use the term “optimal treatment” in the study. Did they get that treatment? If there were ties, you could have gotten either of the two treatments that got the equally good score, did you get that treatment versus did you get anything else?  So then getting back to our analysis, what we really did was kind of a two-stage study. First, we put all of our patients into our pool, into one big analytic model. And we looked to see what are the factors that predict or are associated with a patient either getting no systemic therapy or any systemic therapy. And then as a second question, we look at the patients who got some form of systemic therapy, and then we ask, again, what percentage of those got the optimal treatment or high quality treatment as opposed to one of the more lowly recommended treatment regimens? So that's how we asked it. We found that patients who were low income subsidy recipients, the low income ones, they were both less likely to receive any systemic therapy. And then even the ones that receive systemic therapy, the ones who made it in the door to see their doctor or their part of the system, they still were less likely to get the optimal treatment that was recommended for their cancer type at the time that they were diagnosed. Dr. Davide Soldato: So basically, even when you are a part of this subsidiary program, you still have a lower access to any type of treatment. And even if you get treatment, you kind of get the ones that were not the preferred according to the NCCN guidelines, or at least they were not scoring as well as those specific regimens. But I think that what our audience might be wondering about is that frequently there are also some other types of characteristics, for example, age or number of comorbidities, which can be associated with having a low socioeconomic status. So I was wondering whether in the analysis you kind of looked specifically also at patient factors, for example, income rather than age or comorbidities, and whether you found any significant association with those and whether it was something that you planned to do in your study. Dr. Aaron Mitchell: Yes. So we looked at many patient factors and those included age and they included the degree of comorbidity. And what we saw with respect to those characteristics was not too surprising. We saw that patients who were older were less likely to receive systemic therapy. We saw that patients who had more comorbidities were also less likely to get systemic therapy. And then across our different designations of treatments, we saw that those patients were also less likely to get the optimal treatment for their cancer. This result though, we would say it certainly needs more study in the future, but it's not immediately concerning. And that is because for patients who have more age, more comorbidity, those often correlate with frailty. And so it could be that these patients aren't getting optimally treated or it could be that their oncologists are just making clinically appropriate decisions about patient selection.  We saw as we were doing this work that the treatment regimens that are often getting the highest recommendations from the NCCN, hence, it would become our definition of high quality optimal treatment, are often ones that are aggressive. They're often ones that are multi-drug combinations. They're often ones that it's not just your old antineoplastics, it's the antineoplastics plus an additional immunotherapy or plus a targeted drug. So it's the ones that are more aggressive by and large, and that might be in some cases more than a patient who is older, more frail, could be able to tolerate. And so the oncologist might be making inappropriate judgment to say I'm going to do something a little bit less aggressive here and make an appropriate trade off between anti cancer efficacy and safety.  I think we've got kind of a bookmark there and we can look at those trends in the future. So we saw that kind of as expected, and then we turned and looked towards the low income subsidy. And our premise there is, well, your income shouldn't predict what you're getting clinically. In an ideal world, you'd be able to get the appropriate treatment for a patient, and not depend on whether their income is above or below 135% of the poverty limit. So that one seems more like on its face an immediate concern. Dr. Davide Soldato: Thank you very much for the explanation. I was just wondering, did you make some kind of selection when you were analyzing specific diseases or settings where you included just metastatic patients or you also included patients with early stage neoadjuvant treatments? Because I think that it is also very interesting from the perspective of the objectives that we have as oncologists when we are administering systemic treatments. Dr. Aaron Mitchell: Yeah, thank you for bringing that up. That was also one of the goals of our study was to be broad. And we wanted to look for factors, whether it be low income subsidy, whether it be age, socioeconomic background, etc., things that would be broad predictors of outcomes, and by which I mean care delivery outcomes across the board. So not just for, let's say, metastatic breast cancer, but also across any cancer that a patient might walk in the door with, what are the systemic predictors. And so when you mentioned before that our overall cohort is approximately 9,000 patients, that's 9,000 patients split over a variety of what we call clinical scenarios or clinical indications. And that includes multiple solid tumor as well as liquid tumor malignancies. It includes both patients who are initiating systemic therapy with palliative intent for metastatic disease. It also includes several groups of patients who are getting adjuvant therapy. So we want it to be as broad as possible. Our selection of those scenarios was really done with the goal of being as broad as possible and really bringing in everything that we could within the constraints of our data source. And that was really the only limitation that we applied in concept was tumor types that are common enough to have a meaningful sample of patients to analyze. So, one, are there enough patients? And then two, are you able to identify this specific group of patients within SEER-Medicare data? Because when the NCCN divides groups of patients by biomarkers that are not available in SEER-Medicare, we can't really say, “Oh, we're going to study this group of patients.” That would then be one that we have to leave on the side and not include. But everything else where one of those things didn't apply, we tried to include it as best we could. Dr. Davide Soldato: Thank you very much for the explanation. And among the scenarios that you included in the study, were there any striking differences in terms of access to treatment and access to quality treatment the way you define the study? Dr. Aaron Mitchell: Yes, there were differences between these different cancer types, these different cancer indications, but they're not differences that I want to over interpret or read too much into. Certainly, every cancer indication is going to be different, but when we start getting into the individual cancer types, the sample size does get smaller. And we've not done formal tests of comparison or heterogeneity among cancer types. So I don't want to say that the differences which we certainly do see, like numerically, there are differences in the proportion of patients who are getting optimal treatment versus no treatment. I don't want to say that it's because the low income subsidy status or patient age has a bigger impact, let's say for lung cancer than breast cancer. I want to say that is heterogeneity for potential future study when we are able to do a similar follow up analysis with say a larger sample size. I don't want to over interpret those differences at the moment. Dr. Davide Soldato: I was just wondering in case there was anything in particular that you wanted to highlight. But in the end, I think that we also have to acknowledge that the data are based on claims data, observational data. So maybe you're right when you say we should not over interpret this type of difference.  And this is just to speculate a little bit, do you think that if you would look at this same specific question in a more contemporary diagnosis frame, like for example, you refer to the fact that most of the diagnoses were between 2016 and 2018. Now that we have more and more of these drugs that would qualify as Part B in the adjuvant or new adjuvant setting, do you think that you would see more differences compared to what you observed in the current study or do you think that it would be more or less the same? Of course this was not part of the analysis that you did, but it's just to have your opinion on the topic in general. Dr. Aaron Mitchell: My expectation would be that since not much has changed with respect to the low income subsidy program from the time period of our study until now, my baseline expectation would be that those results would hold. On the other hand, it is the case that there have been improvements to the standard Medicare Part D benefit since the time of our study. So the low income subsidy patients would be paying the same low out of pocket costs that I mentioned before, about $10 a month give or take, for a specialty cancer drug. But what has started to happen is that for everyone else, their coverage has improved. Because in the US we're in the process of closing, or I think now we finally finished, but you know, a few years lag in claims data, we've closed what used to be called the donut hole, where there was this big coverage gap where patients had to pay a large amount out of pocket for drugs. So there might therefore be a narrowing of the difference, let's say between our low income subsidy participants, the lowest income patients, and then everyone else. But not so much because the low income subsidy status improved or changed, but just because the baseline level of coverage for everyone else may have improved, narrowing that gap. So I'd say that would be very possible.  And if your question is more geared towards not so much policy changes, but treatment landscape changes, I would say the big thing that I would maybe guess, and again, this is very much speculation, but you introduce the speculation in TBD on follow up. I think the big change in the landscape has been the broadening indication and uptake of immunotherapy drugs, our PD-1, PD-L1 inhibitors, for a variety of cancer types. And I think the way that that would manifest in our data, were we to repeat it in a more contemporary data set, would be, I think that the access for, let's say, that any systemic therapy among older patients might change. And that is because rather than just having your cytotoxics in hand, the clinical oncologists now know that for many cases there's if not first line therapy, then second line therapy for patients who don't qualify, you can go straight to it, to someone who's not a chemo candidate, you've got a much more tolerable treatment in your back pocket. And so I think that for patients who are more old or more comorbid, we might start to see that a greater proportion of them receive some systemic therapy, it just might not be the cytotoxic agent that is still most highly recommended. It might be, say a single agent, PD-L1 inhibitor, because their oncologist wants to be able to give them something. So I wouldn't be surprised if that gap starts to narrow as well if you're measuring no systemic therapy versus any systemic therapy. Dr. Davide Soldato: And going back to the policy part of the study that you did, do you think that the results of the study that you published in the JCO can better inform policy makers on how to make these treatments more available and be sure that the largest possible proportion of patients gets a systemic treatment and gets the optimal systemic treatment? Dr. Aaron Mitchell: Yes, I do think that this study has some direct and indirect policy implications. I think that our finding is one to highlight the low income subsidy program and maybe help it not to fly under the radar so much anymore. I think all the work that has been done on how much it has helped patients who need oral cancer medications is great, and it shows how beneficial this program can be. We're now shining the light kind of everywhere else and saying, “Okay. That's great. Here's how well it can work when it covers an oral drug, but we've got this group of low income patients who are still at need and they're still very clearly not able to access everything else. When it's not axitinib that they need, it's a pembrolizumab, they're still very much behind the curve and they need some help.” So I think that's one thing just to call attention to this as an ongoing problem. Low income patients, it's not a solved problem yet. It's something that needs further attention.  And then for direct policy implications that are on the table, I think we're about to see the Medicare program be able to start negotiating not just Part D drugs, but also in future years, Part B covered drugs and try to lower the price for everyone, both for insurance, both for Medicare itself. And then to the extent that that boils over to the patient's out of pocket responsibility, it'll start to reduce the patient out of pocket costs as well. So I think we can look forward to hopefully an aggressive negotiation program by Medicare to start to directly lower the prices of Part B cancer drugs that these patients are unable to afford. Dr. Davide Soldato: Thank you very much. You did the research you published in the JCO, but you really seem very passionate about the topic of care delivery and quality of care and policy. So I just wanted to ask on a personal note, how did you come to this area of research which is frequently not one that is very cared for by oncologists? It's more frequently something that biostatisticians or public health scientists put their attention to. I just had this curiosity and I wanted to ask you if you could explain a little bit how you came to this area of research. Dr. Aaron Mitchell: Thank you for asking. That's a great question. I'll tell my favorite story about my journey there. I entered medical school planning to be a clinical investigator or maybe even a basic science researcher, and I had some background in that. I went to medical school at NYU where the teaching hospital is Bellevue, which is a large, well known public hospital within New York City. And my eyes started to open regarding the inequities in the system. You always hear about it, you read about the problems in the US healthcare system, but then when you see it on a day to day basis and you can walk four blocks from a private, very well resourced hospital to see a patient with a similar condition four blocks down the road at a under resourced public hospital getting very different treatments and receiving very different outcomes, the injustice in the system really hits you on a visceral level. And it was really, I would say, as soon as I started my clinical rotations in medical school that I realized maybe that's where I can make the most impact with my career and just really fell into it. By the time I was done with medical school, I then knew that I wanted to do something that was in the health policy space. And then by the time I was done with residency, I was like, “Oh, someone had mentioned the words health services research” and the light went on. It's like, “Oh, that's me. That's what I want to do.” Dr. Davide Soldato: Thank you very much. That was a nice story. And I really think that we should all work towards trying to make sure that the inequities inside of the system are eliminated as much as possible.  So I think that this concludes our interview for today. So thank you again, Dr. Mitchell, for joining us. Dr. Aaron Mitchell: You're very welcome and thank you so much for your interest. Dr. Davide Soldato: We appreciate you sharing more on your JCO article titled, “Quality of Treatment Selection for Medicare Beneficiaries with Cancer.”  If you enjoy our show, please leave us a rating and review and be sure to come back for another episode. You can find all ASCO shows at asco.org/podcasts.   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 opinion, 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.

This Day in Legal History: Corporations Are “Persons” Under 14th AmendmentOn May 10, 1886, the U.S. Supreme Court delivered a landmark decision in the case of Santa Clara County v. Southern Pacific Railroad Company, fundamentally altering the legal landscape for corporations in the United States. This ruling established that corporations were to be considered "persons" under the Fourteenth Amendment and were thus entitled to equal protection rights under state law. The decision arose from a dispute involving Santa Clara County and the Southern Pacific Railroad, which contested certain tax assessments on the grounds that they were discriminatory against the corporation.The Supreme Court, without directly addressing the issue in the oral argument or written opinion, allowed the notion that corporations were persons for the purpose of the Fourteenth Amendment to stand, based on a headnote by the court reporter, which was not part of the official opinion. This headnote indicated that the Chief Justice had acknowledged corporate personhood in relation to the amendment during the proceedings. Although it did not form part of the decision, this assertion guided future interpretations of corporate rights in the U.S.As a result, the ruling provided corporations with expanded protections that had originally been intended to protect the rights of former slaves. Over time, this interpretation has been used to defend corporations in various legal battles, granting them rights comparable to those of individual citizens in many respects. This includes the right to a trial by jury, the right to protection from unreasonable searches and seizures, and the right to free speech.The implications of the Santa Clara decision have been far-reaching and controversial. Critics argue that it has led to an excessive amount of power being held by corporations, influencing political processes and public policy disproportionately. Supporters, however, see the ruling as essential for ensuring that businesses can operate on a level playing field, free from unfair government interference.The Santa Clara case remains a pivotal point in legal history, frequently cited in discussions about the balance between corporate power and public control. It opened the door to subsequent legal challenges and rulings that continue to shape the interaction between corporations, individuals, and the government in the United States. The ongoing debates surrounding corporate influence in politics and society trace back to this seminal Supreme Court decision, underscoring its significance in American legal history.The Biden administration is considering a proposal by Knowledge Ecology International (KEI) and other groups to use U.S. Code § 1498 to seize patents for the cancer drug Xtandi, manufactured by Astellas Pharma, without paying royalties. This move, aimed at reducing the drug's cost, represents a more aggressive stance toward pharmaceutical pricing, leveraging the government's legal abilities to override private patents under specific conditions. Xtandi, costing over $14,000 monthly for uninsured patients, has been a focal point in debates over drug prices. The proposal suggests that because Xtandi was developed with government grants, existing laws provide a mechanism for the government to authorize generic production without compensating the patent holder. Critics, including former US Patent and Trademark Office head Andrei Iancu, argue that this interpretation distorts patent laws and undermines the Hatch-Waxman Act, which regulates drug patent exclusivities and generic entry. Despite skepticism about the administration adopting this aggressive approach, proponents see it as a viable strategy to control drug prices and alter pharmaceutical company behaviors without the need for compensation, sparking a significant legal and ethical debate on the extent of government intervention in private industry.Cancer Drug Price-Cutting Pitch Mulled by HHS as Industry WaitsThe Biden administration and several civil rights groups, including the ACLU, have filed lawsuits against the state of Iowa to challenge a new law, S.F. 2340, which authorizes the arrest and prosecution of individuals who re-enter the U.S. after deportation. The law, signed by Iowa Governor Kim Reynolds, makes "illegal reentry" into Iowa a criminal offense punishable by up to two years in prison and permits state judges to order deported individuals to return to their home countries. Both the federal government and civil rights organizations argue that this state law unlawfully conflicts with federal immigration law and its established procedures for handling illegal entries and deportations. This Iowa law also fails to exempt individuals with legal status in the U.S., such as asylum seekers and visa holders. This move by Iowa reflects a broader trend among Republican-led states, influenced by similar laws in Texas and recently Oklahoma, aiming to enforce immigration laws due to perceived inaction by the federal government on illegal border crossings. A U.S. appeals court recently blocked a similar law in Texas, citing its inconsistency with federal jurisdiction over immigration matters.Biden administration, civil groups sue Iowa over immigrant arrest law | ReutersElon Musk may be required to provide additional testimony in the SEC's investigation into his $44 billion acquisition of Twitter. During a court hearing in San Francisco, U.S. District Judge Jacqueline Scott Corley considered the SEC's request to compel Musk to testify, following another judge's earlier ruling in favor of the agency. The SEC is investigating whether Musk violated federal securities laws during his 2022 purchase of Twitter, now renamed X, particularly concerning his stock purchases and related public statements and filings. Musk had previously participated in the investigation via two videoconference sessions and had provided documents. His legal representation argued that further testimony would impose an undue burden on him, given his responsibilities to multiple companies. The judge questioned the argument that Musk's busy schedule should exempt him from compliance with securities laws. This legal battle is part of an ongoing feud between Musk and the SEC that dates back to a 2018 incident where Musk tweeted about having funding secured to take Tesla private.Elon Musk may be compelled to testify again in SEC's Twitter takeover probe | ReutersThe American Bar Association (ABA) is considering endorsing alternative pathways to lawyer licensing that do not involve passing the traditional bar exam, signaling a significant shift from its longstanding pro-exam stance. This reconsideration is spurred by a task force formed to evaluate the ABA's existing policies, which since 1921 have primarily supported the bar exam as a requisite for legal practice. The draft policy, set for discussion on May 17, encourages states to develop diverse licensing methods. This change comes in response to actions by states like Oregon and Washington, which have already implemented alternatives such as apprenticeships and skills coursework to bypass the bar exam. The ABA's move aligns with efforts to address racial and socioeconomic disparities in bar exam pass rates, which show significantly lower success rates among minority test takers. The National Conference of Bar Examiners acknowledges the ABA's new direction as it prepares to launch a revised bar exam in 2026, highlighting the ongoing evolution in standards for entering the legal profession.Bar exam alternatives, long out of favor with ABA, make inroads | ReutersThe U.S. Federal Energy Regulatory Commission (FERC) is set to finalize two significant rules aimed at enhancing the planning and funding mechanisms for long-distance electric transmission lines. These rules are designed to facilitate the development of a more robust national power grid and address the increasing demand driven by renewable energy sources and electric vehicles. The first rule mandates regional grid planners to develop at least 20-year plans that consider a broad range of benefits, updating the less effective 2011 guidelines. The second rule potentially allows FERC to issue permits for transmission lines even if they are denied by states, focusing on national interest corridors identified by the Department of Energy.The proposed rules have sparked concerns regarding the traditional role of state regulators in siting and permitting transmission lines and the potential sidelining of competitive bidding processes, which some argue could increase costs and project delays. However, proponents argue that the new rules will facilitate much-needed investment in the transmission infrastructure necessary to meet future energy demands and reduce longstanding disparities in regional transmission capabilities. The discussion is also heavily centered around equitable cost allocation, aiming to distribute costs in alignment with the derived benefits, a topic that has historically been contentious and frequently litigated. These regulatory changes are occurring amidst broader administrative efforts to modernize and expand the U.S. electric grid to support a clean energy future.Transmission Rules to Back Planning of Long-Range Power LinesThis week's closing theme is by Bedřich Smetana.Bedřich Smetana, a towering figure in Czech music, stands as one of the pioneering composers of the 19th century, especially noted for his development of a distinctly Czech musical style. Born on March 2, 1824, in Litomyšl, now part of the Czech Republic, Smetana was a child prodigy in both violin and piano. He grew up immersed in a rich cultural atmosphere that fueled his passion for music, leading him to compose from an early age.His early career was marked by the struggle for recognition, balancing a desire to compose with the need to earn a living as a teacher and conductor. Despite these challenges, Smetana's nationalist spirit found expression in his music, which often incorporated Czech folk themes and stories. By the 1860s, he had established himself as a central figure in Prague's musical life, becoming the principal conductor of the Provisional Theatre, where he championed the cause of Czech music.Smetana's personal life, however, was fraught with tragedy. He suffered the loss of his beloved wife and some of his daughters, and later, he was struck with deafness. Yet, these personal hardships only deepened the emotional depth of his compositions. One of his most famous works, "Má vlast" ("My Country"), is a cycle of six symphonic poems that celebrates the Czech landscape, history, and legends.Among these poems, "Vltava" (known in German as "Die Moldau") is perhaps the most internationally celebrated. It beautifully captures the course of the Vltava River as it flows through the Bohemian countryside, underlining Smetana's mastery of orchestral color and melodic contour. This piece serves as a vivid sonic portrait of the Czech landscape, intertwining folk music with the river's thematic journey through the countryside.Today, as we conclude our week, we turn to this poignant piece from Bedřich Smetana's "Má vlast." Without further ado, "Vltava," or "The Moldau," from Bedřich Smetana's symphonic poems "Má vlast" or "My Country." Get full access to Minimum Competence - Daily Legal News Podcast at www.minimumcomp.com/subscribe

Last Thursday, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) approved CRISPR/Cas9 gene-edited therapy exagamglogene autotemcel (exa-cel). Will the FDA follow suit? What can patients expect the price tag to be? Plus, a good handful of approvals for AstraZeneca, Pfizer and Astellas' Xtandi, and Keytruda. Join BioSpace's Lori Ellis, Greg Slabodkin and Heather McKenzie as they discuss the news this week.

The end of the year typically brings a number of FDA approvals, and 2023 is no different. Last week, the Food and Drug Administration approved a new drug, Augyro (repotrectinib) for the treatment of patients with ROS1-positive non-small cell lung cancer.  Also making oncology headlines this week, is an expert update on the cancer drug shortage, research about how the severity of diabetes can impact colorectal cancer outcomes and how vitamin D may be able to mitigate the severity of chemotherapy-induced peripheral neuropathy.   FDA Approves Augtyro for Patients With NSCLC Subset Another week, another FDA approval. This time, the agency approved Augtyro for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.  The drug works by targeting ROS1 oncogene fusions, which can be responsible for the growth of cancer. The approval was based off findings from the phase 1/2 TRIDENT-1 clinical trial, which showed that 79% of patients responded to therapy with the drug, including 6% who experienced a complete response, which is when all signs of cancer disappear.  Bristol Myers Squibb, the pharmaceutical company that manufacturers Augtyro, expects the drug to be available to patients in mid-December.  FDA Approves Keytruda plus Chemo for Advanced HER2-Negative Gastric, GEJ Cancers Also in FDA news last week, the agency approved the immunotherapy drug, Keytruda, in combination with chemotherapy for the treatment of patients with advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.  The approval came after findings from the KEYNOTE-859 trial showed that the immunotherapy-chemo combination improved overall survival) that's time from treatment until death of any cause); progression-free survival (time from treatment until death or disease worsening) and response rate compared to a group that received placebo plus chemotherapy.  FDA Approves Truqap Plus Chemo for Some With HR-Positive, HER-Negative Breast Cancer Additionally, the FDA has approved Truqap with chemotherapy fulvestrant for the treatment of adults with HR-positive or HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations and who have progressed on at least one endocrine-based regimen in the metastatic setting or recurred at or within one year of completing adjuvant therapy. And now this approval was based on the results of the CAPItello-291 trial where among patients with these altered tumors, the median progression free survival was 7.3 months in the Truqap and chemotherapy cohort and 3.1 months in the placebo and chemotherapy cohort. FDA Approves Xtandi for High-Risk Prostate Cancer And the FDA approved Xtandi for the treatment of patients with non-metastatic castration-sensitive prostate cancer, with a high risk of biochemical recurrence, meaning a recurrence that is determined by rising prostate specific antigen levels. According to Pfizer, the manufacturer of the drug, and notably, this marks the first approval of an androgen receptor signaling inhibitor that is FDA approved for this patient population.  The approval is based on findings from the randomized phase 3 EMBARK clinical trial were five-year metastasis free survival, which is the time from treatment until metastatic disease was 87.3% in the Xtandi arm, compared with 71.4% and the leuprolide-only group and 80% in the monotherapy group, according to findings that were published in the New England Journal of Medicine.  Drug Shortages Continue to Be a ‘Serious Problem' in Oncology While the shortage of the chemotherapy drugs, cisplatin and carboplatin, seems to be improving, drug shortages, in general, are not a new problem and likely are not going anywhere soon, according to Corey McEwen, the director of oncology pharmacy services at Massachusetts General Hospital in Bostin.   McEwen explained that most of these drugs are manufactured outside of the United States. The FDA will approve certain locations to make the drugs, which then are shipped to the wholesaler, then the cancer treatment center or clinic and finally, to the patients. However, at no point during that process is there an obligation to be transparent about drugs that are in shortage or at risk to be in shortage.  Additionally, with increased demand and decreased supply, the price of these therapies can go up. At Mass. General, McEwen said that the institution will oftentimes take on the financial burden of the increased cost, because they are mainly focused on getting the drugs in the first place. However, that may not be the case in all cancer treatment centers, leading to more disparities and financial burdens from cancer care.  Diabetes Severity Associated With Poor Colorectal Cancer Survival Research published in the journal, Cancer, analyzed outcomes for patients with diabetes and colorectal cancer who underwent surgery for their cancer. Findings showed that patients with more severe diabetes tended to have poorer survival outcomes. This was particularly the case for patients who were female or in their earlier stages of cancer.  The researchers theorized that the relationship between diabetic severity and cancer prognosis may be explained by three mechanisms:  ·      Diabetes can lead to increased levels of insulin-like growth, which can accelerate tumor growth  ·      High blood sugar levels may result in poor response to chemotherapy  ·      The potential increased accumulation of genetic mutations that result from the high inflammatory burden caused by diabetes  Vitamin D May Help Prevent Chemo-Induced Neuropathy Once again, vitamin D made oncology headlines last week. This time, findings published in the Journal of the National Comprehensive Cancer Network found that patients who were deficient in vitamin D before starting treatment with paclitaxel had higher rates of chemotherapy-induced peripheral neuropathy than patients with sufficient vitamin D levels.  Peripheral neuropathy is a common side effect from certain types of chemotherapy drugs that presents as numbness, tingling or a stabbing feeling in the hands and/or feet. Eventually if the neuropathy gets so bad, patients can have a higher risk of falls or become unable to perform some essential everyday tasks, such as preparing food or getting dressed. There is currently no cure for the condition, so potential prevention or mitigation strategies — like getting enough vitamin D — are particularly important.  I spoke with study author Dr. Dan Hertz who said that while more research is needed in this space, it is worth it for patients to check their vitamin D levels and take a supplement, if needed. 

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. In today's episode, we have several news updates to share with you. Let's get started.## FDA Official Janet Woodcock to RetireJanet Woodcock, a top official at the FDA, will be retiring early next year. Woodcock has been with the agency for an impressive 37 years and has played a crucial role in the FDA's pandemic response. She has also made important decisions regarding opioids, Alzheimer's therapy, and muscular dystrophy drugs.## Homology Enters Reverse Merger with Q32 BioBiotech company Homology has entered a reverse merger with Q32 Bio. This strategic move will result in a combined company operating under Q32's name. Homology recently faced challenges, including staff layoffs and halted research. This merger could potentially help them navigate through these difficulties.## Astellas Acquires Propella TherapeuticsAstellas, a pharmaceutical company, has made a significant acquisition by paying $175 million to acquire privately held Propella Therapeutics. This deal includes an experimental prostate cancer drug. This acquisition reflects the increasing activity in the biotech M&A space.## Eli Lilly Plans $2.5 Billion Manufacturing PlantEli Lilly, a major pharmaceutical company, has announced plans to build a new $2.5 billion manufacturing plant. This facility is aimed at meeting the growing demand for obesity drugs, following the recent approval of their obesity drug, Zepbound. The plant will help prevent shortages and ensure wider access to this drug.## Eli Lilly Invests in German Manufacturing FacilityContinuing on Eli Lilly's expansion plans, they are also investing $2.5 billion in a German manufacturing facility. This investment is specifically focused on meeting the high demand for weight-loss treatments. The German plant will support the supply of Tirzepatide, a drug that has shown promising results in clinical trials for obesity treatment.## AstraZeneca's Truqap Receives FDA ApprovalAstraZeneca's Akt inhibitor, Truqap, has received FDA approval. It can now be used in combination with the endocrine therapy Faslodex for adult patients with advanced HR-positive breast cancer. This approval expands the treatment options for breast cancer patients and provides a new targeted therapy approach.## FDA Approves Pfizer and Astellas' XtandiThe FDA has granted approval for Pfizer and Astellas' Xtandi. This drug can now be used for the treatment of nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis. This approval allows Xtandi to be used earlier in the treatment process, offering a new option for patients with this type of prostate cancer.## Merck's Keytruda Receives Expanded FDA ApprovalMerck has received FDA approval to expand the label of its anti-PD-1 blockbuster drug Keytruda. It can now be used as a first-line treatment option for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. This approval further solidifies Keytruda's position as a leading immunotherapy treatment.## Focus on Disease Prevention in Pharma IndustryThere is a growing conversation around disease prevention in the pharmaceutical industry. Many industry leaders, such as GSK CEO Emma Walmsley and 23andMe CEO Anne Wojcicki, are emphasizing the importance of prevention. GSK is focusing on its pipeline of vaccines, while 23andMe explores the potential of genomics in disease screening. This shift towards prevention comes at a time when life expectancy in the U.S. is declining due to preventable causes.That's all for today's episode. We hope you found these news updates informative and valuable. Stay tuned for more important updates in the Pharma and Biotech world. Thank you for listening to Pharma and Biotech Daily, the podcast that keeps you informed.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Today, we have some exciting news to share with you.## Cytiva's Optimized Method for Analyzing AAV CapsidsCytiva, formerly known as Pall Life Sciences, has developed an optimized method for analyzing adeno-associated virus (AAV) capsids. This method is fast, robust, and cost-efficient, addressing the limitations of current options. The optimized method uses anion exchange chromatography (AEX) with Capto Q chromatography resin to separate empty and full capsids. It has been successfully applied to various serotypes, achieving baseline peak separation. In a recent webinar, Cytiva demonstrated how their method can determine the percentage of full capsids in less than 5 minutes with low sample consumption. This method offers a solution to the challenges faced by process developers and provides a more accurate and cost-effective approach to analyzing AAV capsids.## Real-World Data in Rare Disease ResearchOur next topic is the use of real-world data (RWD) in gaining insights into rare diseases and improving drug development efficiency. RWD expands the insights that clinical trials can provide and helps researchers better understand patients with rare diseases. By analyzing real-world data, researchers can develop new treatments and interventions. However, there are challenges associated with using RWD, such as ensuring data quality and privacy protection. Despite these challenges, leveraging RWD is crucial for optimizing rare disease research.## Johnson & Johnson's Phase III Trial TerminationIn other news, Johnson & Johnson (J&J) has terminated its Phase III trial for Opsumit in pulmonary hypertension based on the recommendation of an independent data monitoring committee. Opsumit is a blockbuster drug for J&J, generating significant revenue for the company. This termination is a setback for J&J, but they continue to explore other opportunities in the field.## Allegations Against Bristol Myers SquibbBristol Myers Squibb (BMS) has been accused by Blue Cross and Blue Shield of Louisiana of conducting patent fraud to sustain a monopoly on its multiple myeloma drug Pomalyst. The healthcare insurance company alleges that BMS fraudulently extended patent protections for Pomalyst, preventing generic versions from entering the market. This case highlights the importance of fair competition and access to affordable treatments.## Roche's Successful Investment in Alnylam PharmaceuticalsOn a positive note, Roche has seen a return on its investment in Alnylam Pharmaceuticals. Alnylam's Phase II trial for its RNA interference therapy for hypertension showed promising results, reducing blood pressure in hypertensive patients. This collaboration between Roche and Alnylam has the potential to lead to innovative treatments for patients.## Astellas Withdraws Lawsuit Against Department of Health and Human ServicesAstellas has withdrawn a lawsuit against the Department of Health and Human Services after its prostate cancer therapy Xtandi was not included in Medicare's initial drug price negotiation list. While disappointed with the decision, Astellas remains committed to working with the government to ensure access to its therapy for Medicare beneficiaries.## Challenges in the Biotech IndustryLastly, the biotech industry is facing challenges as it navigates the post-pandemic markets. The risks are high, with therapeutics potentially failing. It is crucial for the industry to communicate its positive impact and build trust with the public. Recent leadership shakeups at companies like Biogen, Sanofi, and Bristol Myers Squibb highlight the need for stability and improvement within the industry.That's all for today's episode. Thank you for tuning in to Pharma and Biotech Daily, where we bring you the most important news in the world of Pharma and Biotech. Stay tuned for our next episode, and have

Summary: In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from August 21, 2023 – August  25, 2023.  Please check back every Monday morning so that you can stay up to date. See more details summaries and links to prescribing information at nascentmc.com/podcast Here are the highlights:  FDA Approves Tyruko as First Biosimilar to TysabriThe FDA approved Tyruko as the first biosimilar to Tysabri for treating relapsing forms of MS in adults. It has similar risks and side effects as Tysabri and is also approved for treating certain Crohn's Disease patients. The product is available from Sandoz Inc. Source Abrysvo RSV Maternal Immunization ApprovedThe FDA approved Abrysvo, a vaccine for preventing respiratory disease caused by RSV in infants through maternal immunization. The approval is based on Phase 3 MATISSE trial results. Abrysvo was also approved for older adults earlier this year. Source sBLA Filed for Rybrevant in Advanced NSCLCAn sBLA was filed for expanded approval of Rybrevant, combined with certain drugs, for treating advanced non–small cell lung cancer with EGFR exon 20 insertion mutations. The approval was granted to Janssen Pharmaceuticals. Source Priority Review of Xtandi in Early PCaXtandi received Priority Review by the FDA for an expanded use in early-stage prostate cancer. The sNDA is based on a Phase 3 EMBARK trial, where Xtandi showed significant benefits. The product is manufactured by Pfizer, Inc.  Intro and outro music Garden Of Love by Pk jazz Collective    

Get our free download! Implementing AMA Style – 8 Things to Get Right In this episode, we discuss the latest FDA approvals from June 19 –  June 23, 2023.  Here are the key highlights: ·       The FDA has given approval to Pfizer's Talzenna and Xtandi for treating metastatic castration-resistant prostate cancer in adults with certain genetic mutations. The approval came following successful Phase 3 TALAPRO-2 trial results. ·       Sarepta Therapeutics' Elevidys, a gene therapy for Duchenne muscular dystrophy, has received accelerated approval from the FDA. Elevidys, the first gene therapy of its kind, is approved for ambulatory pediatric patients aged 4-5 years with confirmed mutation in the DMD gene. ·       Jardiance and Synjardy, initially approved for adults in 2014 and 2015 respectively, have now been approved by the FDA for use in children aged 10 and older with type 2 diabetes. This approval came on the back of the DINAMO phase 3 trial results. ·       Pfizer's Litfulo, a once-daily oral treatment for severe alopecia areata for individuals aged 12 and older, has received FDA approval. This is the first treatment approved for adolescents with this condition.  ·       Amgen's Blincyto has received FDA approval for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease. This moves the drug from an accelerated approval to a full approval status. ·       Argenx's Vyvgart Hytrulo, a subcutaneous version of the original drug Vyvgart, has been approved by the FDA. It is indicated for generalized myasthenia gravis (gMG) in adult patients who test positive for anti-acetylcholine receptor antibodies. ·       Bayer's Ultravist (iopromide) injection, the first contrast agent for contrast-enhanced mammography, has been approved by the FDA. This new imaging tool enhances visibility of suspected or known breast lesions. ·       The FDA has refused to grant accelerated approval to Intercept Pharmaceuticals' drug obeticholic acid (OCA) for treating non-alcoholic steatohepatitis (NASH). This is the second time the FDA has declined to approve the drug for NASH due to potential risks. ·       Please check back every Monday morning for last week's approvals so that you can stay up to date.  See all the episodes here. ·       This podcast is brought to you by Nascent Medical. If you're a project manager at a CME or medical communications agency and need on-call medical writing assistance please visit Nascent Medical. We are a team of MD- and PhD-level medical writers and can create slide decks, white papers, ad board summaries, manuscripts, needs assessments, and much more. We also do medical editing using AMA style and factchecking. Visit nascentmc.com  ·       Intro and outro music ·       Garden Of Love by Pk jazz Collective

Pink Sheet reporter and editors discuss Moderna CEO's Stéphane Bancel's defense of his company and COVID-19 vaccine pricing at the Senate Health, Education, Labor and Pensions Committee, the NIH denying a petition to use government march-in rights for Xtandi, and Tofersen receiving a positive US FDA advisory committee recommendation for use in ALS. More on these topics from The Pink Sheet: Moderna CEO Hearing Highlights Dissatisfaction With Patient Assistance Programs https://pink.pharmaintelligence.informa.com/PS147930/Moderna-CEO-Hearing-Highlights-Dissatisfaction-With-Patient-Assistance-Programs Moderna CEO Reminds People About Value Of Government Negotiations At Senate Hearing https://pink.pharmaintelligence.informa.com/PS147939/Moderna-CEO-Reminds-People-About-Value-Of-Government-Negotiations-At-Senate-Hearing After Xtandi, Will Government Ever Seek March-In Rights Over Drug Pricing? https://pink.pharmaintelligence.informa.com/PS147929/After-Xtandi-Will-Government-Ever-Seek-MarchIn-Rights-Over-Drug-Pricing Xtandi Still Faces Likely US Price Cut Even As It Avoids ‘March In' Proceeding https://pink.pharmaintelligence.informa.com/PS147940/Xtandi-Still-Faces-Likely-US-Price-Cut-Even-As-It-Avoids-March-In-Proceeding Accelerated Approval Is US FDA Panel's Preferred Path For Biogen/Ionis's Tofersen In ALS https://pink.pharmaintelligence.informa.com/PS147918/Accelerated-Approval-Is-US-FDA-Panels-Preferred-Path-For-BiogenIoniss-Tofersen-In-ALS Accelerated Approval: Potential Sources Of Confirmatory Evidence Weighed At Tofersen Review https://pink.pharmaintelligence.informa.com/PS147937/Accelerated-Approval-Potential-Sources-Of-Confirmatory-Evidence-Weighed-At-Tofersen-Review

Fierce's JPM Week event was packed full of informative panels, executive interviews and fireside chats. So for today's episode, we've pulled out a couple of snippets to take you inside the gathering. First up, listen in on Fraiser Kansteiner's lively panel discussion on how companies will keep their bottom lines strong while navigating the drug pricing policies that the Biden administration rolled out just last year. You will also hear from Zoey Becker's interview with Bayer's Christine Roth. As head of the oncology strategic business unit, Roth talks about the plans to establish Bayer as a strong competitor in the cancer space. To learn more about topics in this episode: 2023 forecast: Despite Biden's drug pricing win, the biopharma industry is not 'anywhere near done with this conversation' To bolster IRA, lawmaker calls for new action to scrutinize cancer drug launch prices Pfizer, GSK, AbbVie and many more celebrate New Year with price hikes: report JPM23: Bayer hikes sales targets for Kerendia, Nubeqa to $3B each Look out, Pfizer. With new approval, Bayer's Nubeqa is set to challenge Xtandi's prostate cancer crown Bayer's blockbuster hopeful Nubeqa debuts in later-stage prostate cancer in UK under early access program Bayer poaches GlaxoSmithKline exec to lead expanding oncology business—including a blockbuster hopeful Fierce JPM Week The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

Bayh-Dole helped the U.S. reverse its downward spiral into irrelevance and become the dominant force that it is today. The world economy is unraveling again, and Joe Allen is a firm believer in the power of the Bayh-Dole Act to turn things around for countries across the world. Not everybody agrees. Despite the fact that the Bayh-Dole Act is foundational to the U.S. economy, it has been under attack since it was passed in 1980. From day one, Joe Allen has been there to fight the battles on its behalf. Listen to this episode to hear why protecting Bayh-Dole means protecting innovation.    In This Episode: [00:52] An overview of Joe Allen's career, from Senate Judiciary Committee for Senator Birch Bayh to leader of the Bayh-Dole Coalition. [02:12] March-in right requests that have been filed relating to the prostate cancer drug, XTANDI. [03:15] Why the US patent system is under attack. [04:10] The profound impact that the Bayh-Dole Act had on the US economy.  [06:09] Joe explains why the Bayh-Dole Act has the provision of a march-in right.   [07:30] Four circumstances under which the government can invoke the march-in provision.  [09:04] Misconceptions held by opponents of the Bayh-Dole Act.   [16:16] The enormity of what is at stake if the march-in relating to XTANDI goes ahead. [21:20] Attacks that were waged against Bayh-Dole when it was passed. [23:26] An explanation of the Exceptional Circumstances provision in the Bayh-Dole Act, and how the DOE is trying to take advantage of this.  [30:23] The dangers of micromanagement in the innovation space.  [33:54] How the COVID-19 mRNA vaccine came into existence in such a short space of time.   [39:27] Joe shares his thoughts on COVID-19 vaccine patent waivers.   [43:53] The role that Joe played in assisting South Africa to change its approach to innovation.  [48:04] Joe's passion for advocating for the Bayh-Dole Act in the US and internationally.  [49:30] A story that epitomizes the driving force behind our economy.  [50:30] Why Joe is optimistic about the future of Bayh-Dole, despite the many reasons not to be.  [53:02] The most effective way to fight back against Bayh-Dole oppressors.  [55:42] A story that highlights the real-world value of the Bayh-Dole Act.    Find Joe: Email  

With a family history of prostate cancer, Max Schlueter wasn't surprised when he was diagnosed.  What did come as a surprise was his cancer metastasizing to hip and spine.  A treatment regimen combining Lupron and chemotherapy kept the cancer at bay; however, years later, the cancer returned years later attacking the nerve linings of his legs and feet, rendering him a paraplegic.  Between determination, his Buddhist faith and a stellar team of physician therapists, Max regained his ability to walk.  Now retired, he has returned to an active lifestyle of skiing, kayaking and mountain climbing.

ASCO: You’re listening to a podcast from Cancer.Net. This cancer information website is produced by the American Society of Clinical Oncology, known as ASCO, the world’s leading professional organization for doctors who care for people with cancer. 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. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Cancer research discussed in this podcast is ongoing, so clinical trials described here may no longer be enrolling patients, and final results are not yet available.  Before any new cancer treatment can be approved for general use, it must be studied in a clinical trial in order to prove it is safe and effective. In today’s podcast, members of the Cancer.Net Editorial Board discuss 3 clinical trials that are exploring new treatment options across kidney, bladder, and prostate cancer. This podcast will be led by Dr. Timothy Gilligan, Dr. Tian Zhang, Dr. Petros Grivas, and Dr. Neeraj Agarwal. Dr. Gilligan is an Associate Professor and Medical Oncologist at the Cleveland Clinic Taussig Cancer Institute. He has no relevant relationships to disclose. Dr. Zhang is an associate professor of medicine at Duke University School of Medicine and is a medical oncologist at Duke Cancer Institute. She has served in a consulting or advisory role for Bristol-Myers Squibb and Merck, and has received research funding from Astellas Pharma. Dr. Grivas is the clinical director of the Genitourinary Cancers Program at University of Washington Medicine. He is also an associate member of the clinical research division at the Fred Hutchinson Cancer Research Center. He has served in a consulting or advisory role for Bristol-Myers Squibb and Merck. Dr. Agarwal directs the Genitourinary Oncology Program at the Huntsman Cancer Institute at the University of Utah. He has served in a consulting or advisory role for Bristol-Myers Squibb, Merck, and Astellas Pharma. View full disclosures for Dr. Gilligan, Dr. Zhang, Dr. Grivas, and Dr. Agarwal at Cancer.Net. Dr. Gilligan: Hi. I'm Dr. Timothy Gilligan from the Cleveland Clinic Taussig Cancer Institute. I'm joined today by Dr. Tian Zhang from the Duke Cancer Institute, Dr. Petros Grivas from the University of Washington and Fred Hutchinson Cancer Research Center, and Dr. Neeraj Agarwal from the Huntsman Cancer Institute and University of Utah. Today, we're going to discuss 3 ongoing clinical trials in kidney, bladder, and prostate cancer. As you may know, clinical trials are the main way that doctors are able to find better treatment for diseases like cancer. Patient participation is vital for clinical trials. By participating in the clinical trial, you can directly help researchers develop better treatment, reduce side effects, or even reduce the risk of cancer altogether. The 3 trials we'll discuss today were chosen by members of the Cancer.Net Editorial Board Genitourinary Cancers panel from the Trials in Progress abstracts that were presented at ASCO's 2020 Annual Meeting. Because these are ongoing clinical trials, final results from these studies are not available yet. I'd like to note that none of us have any direct involvement with any of these trials. To view our full disclosures, please view the show notes for this episode on Cancer.Net. We're going to start with Dr. Zhang discussing the trial CheckMate 914. Why don't we begin with who the study is designed for? CheckMate 914 is a study in the adjuvant setting, so it's a study after patients have had their primary kidney cancers removed, and everybody needs to have a kidney tumor that's either 7 centimeters or larger or have extension beyond the kidney or any nodal involvement. So after their kidney tumors have been removed, this study really is in that timeframe after nephrectomy or after surgery with complete resection of their tumor. Dr. Gilligan: What's the current standard of care for these patients if they're not on a trial like this? Dr. Zhang: We often will compare against that standard which currently in the adjuvant setting we either do observation until disease recurrence or there is 1 oral treatment that's approved called sunitinib. But sunitinib really has some controversial data around it, and so it's not often used. And so currently, many patients are still observed as standard of care in the setting. Dr. Gilligan: And so if a patient goes on this trial, what can they expect?   Dr. Zhang: So patients who are enrolled to CheckMate 914 are randomized to either a combination immunotherapy called ipilimumab with nivolumab, which is approved in the metastatic setting for kidney cancer, or they're placed on placebo for these 2 treatments, or there is a third cohort that receives nivolumab alone with a placebo of ipilimumab. And so these patients are receiving either active immunotherapies or a placebo, which would be our current standard of care, sort of observation until disease recurrence. Dr. Gilligan: So patients will either get the current standard, which is observation, or else they'll have 1 drug or 2 drugs if I'm understanding correctly? Dr. Zhang: That's right. Dr. Gilligan: What is the hope of this study? What is the outcome that we're hoping to see? Dr. Zhang: The primary outcome of this study is disease-free survival, so that means time until disease recurrence for all comers. And we're really trying to prolong time until disease recurrence or time until metastasis for these patients. There are some secondary outcomes that are very important as well, so prolonging overall survival as well as the incidence of adverse events that are seen from these treatments. And then there is an independent radiographic assessment to look for disease-free survival intervals as well. Dr. Gilligan: And the hope is that these treatments will prevent recurrence or at least delay recurrence then? Dr. Zhang: That's absolutely correct, yes. And we have had 2 other adjuvant trials with immunotherapies in this space of atezolizumab and pembrolizumab, but those trials have finished accruing. And so this is the main ongoing and accruing trial that's looking at active immunotherapy options in this space. Dr. Gilligan: What risks should patients be aware of that they might encounter if they go on this treatment? Dr. Zhang: So with all immunotherapies, we talk a lot about the immune mediated adverse events and just the usual rundown of those. And in my clinic, we talk a lot about the common rashes. In the GI tract, it can cause some inflammation or colitis. Very rarely, it can cause some inflammation in the lungs or liver and then very commonly, endocrine dysfunction. So we watch pituitary, thyroid, adrenal, and pancreas function very carefully. But all of these side effects are well described for the ipilimumab, nivolumab combinations as well as nivolumab on its own in the metastatic setting. So most people should know what to monitor for and what we're looking out for and how to manage these toxicities. Dr. Gilligan: Right. So these are drugs that have been in wide use for some years now, so we have significant experience managing the side effects is what I'm hearing you say. Dr. Zhang: That's right. Dr. Gilligan: Is this trial still open to patients? Dr. Zhang: Yes. This trial is still accruing. It's a global study about to enroll up to 1,600 patients. So it's a very large global trial that is still active and still accruing patients. So I would encourage people and also oncologists to refer patients for the trial at a center close to them if possible. Dr. Gilligan: And when might we expect results for a study like this? Dr. Zhang: These adjuvant studies take a while to finish accruing and then it takes a while to finish seeing the data. So I would hazard a guess that we're still years away from seeing the data from this trial. Dr. Gilligan: So once again, this is for people who have had surgery to remove a kidney cancer and looking at ways to reduce the risk of subsequent relapse. Well, thank you for summarizing that so coherently and succinctly. Let's move on now, and we're going to talk about the trial KEYNOTE-992 with Dr. Grivas. Dr. Grivas, who is this study designed for? Dr. Grivas: So this is a clinical trial, a phase III clinical trial that applies to patients who opt to pursue what we call bladder preservation, which is an attempt to keep the bladder intact and still try to treat bladder cancer with concurrent use of chemotherapy and radiation. And this bladder preservation approach applies to a proportion of patients with bladder cancer still in the bladder but not spread. And as I mentioned before, the decision to pursue that strategy depends on particular patient characteristics, how the cancer looks on the CAT scans, and also how it looks under the microscope. Dr. Gilligan: What is the current standard of care for these patients? Dr. Grivas: So patients who are characterized as great candidates for this bladder preservation approach, because this does not apply to everybody with bladder cancer, the standard of care right now is patients undergo what we call a transurethral bladder tumor resection, which means that the urologists go through the urethra and they resect or remove or scrape, remove the visible bladder tumor, and then the patients undergo concurrent, meaning at the same time, chemotherapy and radiation. Dr. Gilligan: How does the study aim to improve or change the standard of care? What would be different as a result of the study if it's successful? Dr. Grivas: So this particular clinical trial, the KEYNOTE-992, is asking the question whether the addition of immunotherapy with 1 of those immune checkpoint inhibitors that activates the immune system, does this addition add value in the combination of chemotherapy and radiation? So the patients are being randomized by a computer system to either getting chemotherapy-radiation, as is the standard of care that we just discussed, or chemotherapy plus radiation which is standard of care, plus the addition of this drug called pembrolizumab, which is an immunotherapy aiming to activate the immune system. Dr. Gilligan: And it's given at the same time as the chemotherapy and radiation on the study? Dr. Grivas: That is correct. It's given at the same time. And then there is also some—what we call continuation of pembrolizumab for some time after the end of chemotherapy and radiation, and pembrolizumab in this study is given every 6 weeks. Dr. Gilligan: And what makes people think that this might be helpful to add this additional treatment? Dr. Grivas: The notion is that the addition of immunotherapy to chemotherapy-radiation therapy has the potential to make the chemotherapy, radiation therapy work better. What happens sometimes when you give chemotherapy-radiation, this can actually result in a killing of some cancer cells and the contents of those cancer cells can be released, and they may be recognized by the immune system and stimulate the immune response. So if you combine that chemotherapy and radiation with immunotherapy with this agent that stimulates the immune system, the assumption is that this may work better compared to chemotherapy and radiation alone. But we have to do this trial to confirm whether this is true or not. Dr. Gilligan: So patients going on the study, basically, either they'll get the standard of care, which is the chemotherapy and radiation, or the standard of care plus the addition of immunotherapy to see if that results in better outcomes. Am I understanding that correctly? Dr. Grivas: That's exactly right. And the outcomes are being measured by how many patients maintain the bladder intact, in place without the need to remove it, without the need for cystectomy. And also, at the same time, we want to see if those patients can maintain a cancer-free status, so whether the treatment results in a cancer-free state and whether we are measuring a recurrence as Dr. Zhang mentioned before, if the cancer comes back. And also, of course, we measure how many patients are alive over time. So the goal is to see if we can improve upon the rate of patients with no cancer coming back, no recurrence, and being able to keep the bladder intact if possible. Dr. Gilligan: So for both of these trials, the question seems to be if we intensify treatment, can we increase the cure rate and keep patients cancer-free longer? Dr. Grivas: That's exactly right, and that's the promise or the assumption of this trial, whether the addition of immunotherapy to chemotherapy and radiation can improve those chances. Dr. Gilligan: What are the known risks that patients should be aware of? Dr. Grivas: As Dr. Zhang mentioned before, every time we have the immunotherapy in clinical trials or in clinical practice, we have to do a good job educating, of course, all the medical providers, team members, and the patients for early recognition and reporting of what we call immunotherapy-related potential side effects. And as we discussed earlier, any organ of the immune system could be a target of an activated immune system. The reality is that if the side effects from immunotherapy happens, usually it's a mild to moderate degree and usually can be managed by holding of the immunotherapy drug and maybe sometimes give some steroids to cool down the immune system. Obviously, we need to be extra vigilant, and I always err on the caution of overeducated patients to avoid underreporting so we make sure we know ahead of time if a side effect happens. Dr. Gilligan: Is there any reason to be worried that immunotherapy could make the side effects of chemotherapy and radiation worse? Dr. Grivas: It's a great question, and we have to look in that during the course of the trial. The notion is so far, based on the available data, that it's safe to combine chemotherapy, radiation, and immunotherapy. There have been some early data suggesting that, and this is reassuring. At the same time, we need, again, to be extra vigilant, again, over-educating our patients to report any changes so we can be able to compare the potential side effects in the 2 groups. But so far, it seems to be a feasible strategy. Dr. Gilligan: Good. And is this trial still open for patients? Dr. Grivas: Yes, it is open and accruing patients actively, and I think it's a great opportunity for patients to discuss with their providers, urological oncologists, medical oncologists, radiation oncologists, whether they could be good candidates for this bladder preservation approach, if that's a good fit for them and the particular cancer at hand, and if so, whether they can be candidates for this trial or another trial called SWOG 1806, which is in the same space and setting. Dr. Gilligan: And when might we expect results from the study? Dr. Grivas: It may take time because this trial is still early in the accrual process. It may take a few years. The current estimate is probably 2026, so 5 years from now. However, the faster these trials accrue, maybe the faster is to have the results. So this might have been overestimation, but it depends with how quickly the study will accrue patients. It's a very exciting study and definitely, I encourage patients to discuss this and the SWOG 1806 with their providers. Dr. Gilligan: Thank you very much. We're going to move on now, and Dr. Agarwal will tell us about the KEYNOTE-991 study. Dr. Agarwal, who is this study designed for? Dr. Agarwal: This is a study which is designed for patients with newly diagnosed metastatic castration-sensitive prostate cancer. In simple words, this is for those patients who have been diagnosed to have a prostate cancer which has gone to different parts of the body. Dr. Gilligan: And what's the current standard of care for these patients if they don't go on the study? Dr. Agarwal: Fortunately, the current standard of care has gone through a paradigm shift in the last 5 to 6 years. It started with chemotherapy with docetaxel being approved for these patients in 2014 with 2 positive clinical trials showing benefit for docetaxel chemotherapy as far as improvement of survival is concerned. After that, 3 more drugs known as novel androgen axis inhibitors, so deeper blockade of androgen pathway, which is a driver behind prostate cancer progression. So these 3 drugs, abiraterone, or also known as Zytiga, enzalutamide, also known as Xtandi, and apalutamide, also known as Erleada. These 3 drugs and chemotherapy are currently approved agents for our patients with newly diagnosed metastatic prostate cancer. Dr. Gilligan: And what is this study looking at to potentially change that or to add another option? Dr. Agarwal: So this study is using the backbone of androgen deprivation therapy, which is standard testosterone suppression therapy, plus enzalutamide or Xtandi. And then patients who are receiving the standard of care therapy with standard testosterone suppression therapy, plus enzalutamide, they will be randomized to pembrolizumab versus placebo. Pembrolizumab is an approved immunotherapy for multiple cancer types and pembrolizumab, also known as Keytruda, works by activating our immune system to fight against cancer cells. In a way, this study is actually testing whether addition of this novel immunotherapy pembrolizumab to existing regimen of androgen deprivation therapy plus enzalutamide is going to improve survival outcomes. Dr. Gilligan: What do we know about immunotherapy and prostate cancer? Dr. Agarwal: So far, immunotherapy, as we call them, immune checkpoint inhibitors, many of them are approved for multiple cancer types. They have not been successful as single agents in the context of advanced prostate cancer. So this is a trial which is testing whether immunotherapy, the pembrolizumab is going to be effective in combination with enzalutamide and testosterone suppression therapy. Dr. Gilligan: So patients will get the standard of care therapy either way. And then the question is, does adding immunotherapy make it even more effective than it is without it? Is that correct? Dr. Agarwal: That's true. The primary end points of the trial are overall survival and radiographic progression-free survival, which basically means the investigators are going to look for improved survival, overall survival, and delaying of disease progression by adding pembrolizumab. Dr. Gilligan: And we've already discussed the risks of immunotherapy on the previous 2 trials, but can you tell us again for patients who are particularly interested in this study what risks should they be aware of? Dr. Agarwal: So pembrolizumab belongs to a class of drugs known as PD-1 or programmed death 1 receptor inhibitor. Usually, this class of drug, as a class, these are highly well-tolerated drugs and only a small number of patients, I would say less than 5% of patients, would develop grade 3 or 4 side effects which will require treatment with corticosteroids like prednisone. And those side effects usually happen when these immune checkpoint inhibitors are able to activate the immune system beyond desired limits. And when the immune system is activated to very high levels, the immune system can attack our own body and can result in diarrhea, skin rashes, liver enzyme abnormalities, and if not controlled in time can lead to hepatitis, which is inflammation of the liver, inflammation of the lungs causing pneumonitis or cough, dry cough mostly. So these are the common grade 3, 4 side effects which happen in up to 5% of patients with pembrolizumab.   Dr. Gilligan: Just for our listeners in case they're not familiar, when you talk about grades 3 and 4 toxicities, what should they understand that to mean? Dr. Agarwal: In simple words, I would say grade 1 and 2 side effects are the ones which do not require any systemic therapy with steroids. Patients can go on with their daily activities without much problems. And mostly, these are controlled with medications which are over-the-counter. Even if we use prescription medicines, they're usually not able to affect the patient's overall lifestyle or quality of life. So these are the side effects which are pretty easily manageable mostly with over-the-counter drugs, symptomatic drugs, and patients lifestyle and quality of life are usually not affected by the side effects. And grade 3 and 4 side effects are those which require intensive therapy, in this context, with prednisone or corticosteroids sometimes requiring hospitalization and requiring multidisciplinary care with other specialists who are specializing in gastroenterology or pulmonology or on many other specialties. So that's how I would like to simplify the definition of grade 1, 2 versus grade 3, 4 side effects. Dr. Gilligan: That's great. Thank you very much. Is the trial still open for accrual? Can patients still go on it? Dr. Agarwal: Yes. Yes. Trial actually just opened for accrual, which is good news for our patients. And I would like to highlight that patients who have been diagnosed with newly diagnosed metastatic prostate cancer and they have started hormonal therapy like androgen suppression therapy, they still have 3 months to enroll in the trial. So if you have been diagnosed with metastatic prostate cancer and if you have started the treatment with testosterone blockade therapy, you can still go on the trial. You have 3 months to go on this clinical trial. And if you have started chemotherapy with docetaxel, which is a standard of care for our patients with this diagnosis, you can still go on the trial after receiving up to 6 cycles of chemotherapy with docetaxel. So this trial allows actually patients to go on the trial for up to 3 to 6 months after being diagnosed with metastatic prostate cancer. Dr. Gilligan: So that's very helpful to know. At the conclusion of chemotherapy, they would then start the enzalutamide and either the pembrolizumab or placebo? Dr. Agarwal: That's correct. Dr. Gilligan: Well, great. And when do we expect to see results from the study? Dr. Agarwal: So as we know this, which is great news for our patients, survival has gone up by almost 2 to 3 fourths over the last 10, 15 years, and in this disease setting, any trial takes up to 5 to 6 years to show results. So I estimate based on the available information on the ClinicalTrials.Gov website, the trial is scheduled to finish in 2026. Dr. Gilligan: I see. Well, great. So thank you very much. Thank you all 3. That's hopefully a helpful summary of these 3 important new trials. Dr. Agarwal: Yes, it's a pleasure to be here, Tim. Dr. Grivas: Thank you so much. Dr. Gilligan: Thank you. Thank you for listening to this podcast. There are many different clinical trials currently enrolling people with genitourinary cancers. If you're wondering whether participating in a clinical trial might be right for you, please talk to your health care team. ASCO: Thank you, Drs. Gilligan, Zhang, Grivas, and Agarwal. Visit www.cancer.net/clinicaltrials to learn more about participating in clinical trials. All treatments have side effects—please talk to your health care team about possible side effects to watch out for. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play.

The treatment landscape for men with advanced prostate cancer keeps on shifting and expanding. As new therapy options continue to emerge, it is important to understand which treatment options are currently available and how they work in fighting the disease. To highlight a few of the new options, we have Dr. Natasha Kyprianou, an award-winning prostate cancer investigator, joining us on the podcast today to help you get up to speed. Stay tuned for more! Dr. Natasha Kyprianou completed her fellowship in molecular oncology at Johns Hopkins University and in molecular biology at the Imperial Cancer Research Fund in London, UK. She is a professor in the Department of Urology in Oncological Sciences at Mount Sinai Medical Center in New York City and a member of the National Cancer Institute-designated Tisch Cancer Institute. She has also been active nationally and internationally in several leadership positions, including being a board member of the International Prostate Health Council, member of the American Urologic Association Education Council, and honorary board member of the EAU Council, and has served as President of the Society for Basic Urologic Research. It is also worth noting that she was also the Chair of the Department of Defence Congressional Directed Program for Prostate Cancer Research, and was the first female to be elected to this position. Her research focuses on the molecular mechanisms underlying prostate cancer progression to metastasis and apoptosis-driven molecular therapeutics that are targeting urologic tumors. During her career, she has received numerous awards, including being the first female to be awarded by the American Urologic Association for her contribution to urology research. Be sure to listen in to find out what Dr. Kyprianou has to say about the new treatment options that are currently available for advanced prostate cancer. Disclaimer: The Prostate Health Podcast is for informational purposes only. Nothing in this podcast should be construed as medical advice. By listening to the podcast, no physician-patient relationship has been formed. For more information and counseling, you must contact your personal physician or urologist with questions about your unique situation. Show highlights: Dr. Kyprianou explains what motivated her to follow the path she has taken to get to where she is today. More than thirty-thousand men will die of prostate cancer in 2021. The survival rates for prostate cancer drop dramatically once cancer has metastasized to distant sites. Dr. Kyprianou explains what it means for a man to undergo Androgen Deprivation Therapy (ADT). Dr. Kyprianou discusses the novel agents developed in recent years for the treatment of advanced prostate cancer. Dr. Kyprianou talks about the role of the androgen receptor in driving advanced prostate cancer. Dr. Kyprianou explains how the new novel medication, Enzalutamide, also known as Xtandi, works in helping men with advanced prostate cancer. Dr. Kyprianou explains from a research perspective how a treatment like Enzalutamide gets discovered and then ultimately brought to the point where it becomes available to the consumer. Dr. Kyprianou talks about some of the more commonly reported side-effects of Enzalutamide. How the novel agent, Abiraterone, or Azteca, works in helping men with advanced prostate cancer. Dr. Kyprianou explains why men need to keep getting their ADT injections with the new therapy once their prostate cancer has become resistant to the standard hormonal therapy. Dr. Kyprianou discusses what the next ten years hold for the advancement of treatment options for men with advanced prostate cancer. Links and resources: Follow Dr. Pohlman on Twitter and Instagram - @gpohlmanmd  Get your free What To Expect Guide (or find the link here, on our podcast website)   Join our Facebook group  Follow Dr. Pohlman on Twitter and Instagram  Go to the Prostate Health Academy to sign up for the wait-list for our bonus video content.  You can access Dr. Pohlman's free mini webinar, where he discusses his top three tips to promote men's prostate health, longevity, and quality of life here.

Joel T Nowak from Cancer ABCs discusses with Dr. Rana McKay, Associate Professor of Medicine at the Moores Cancer Center at the University of California in San Diego, her recently published article that analysizes real world data that demonstrates that Provenge (sipuleucel-T), an immune therapy for castrate resistant metastatic prostate cancer (CRMPC), can reduce the risk of death over and above the newer hormone treatments that have been FDA approved . Dr, McKay evaluated a large medicare data base and determined that despite the addition of the many second generation hormone treatments like Zytiga, Xtandi and Nubequa Provenge continues to lower the risk of death for men with CRMPC. She also discussed research that she has ben involved in that has been evaluating survival risks for men with prostate cancer who get the COVID-19 virus. Support the show (https://www.cancerabcs.org/new-page-2/)

This episode of PROSTATE PROS reviews and summarizes the year’s advancements in prostate cancer as well as looks forward to future updates. Beyond prostate cancer, the episode examines how COVID-19 has impacted the healthcare landscape and discusses news of the vaccine. Catch up on the latest and stay tuned for an exciting announcement. Liz:  [00:00] We have an exciting prostate cancer update.  Since recording this episode, the FDA recently approved the PSMA PET scan.  Keep that in mind when listening to the episode.  If you’d like further information, visit fda.gov. Dr. Scholz: [00:18] We’re guiding you to treatment success and avoiding prostate cancer pitfalls. I’m your host, Dr. Mark Scholz. Liz: [00:24] And I’m your cohost, Liz Graves. Dr. Scholz: [00:28] Welcome to the PROSTATE PROS podcast. Liz: [00:31] A lot has happened this year and we’ve covered many topics on the podcast. This episode we wanted to highlight a couple of exciting advancements and talk about some updates. Dr. Scholz: [00:44] The elephant in the living room of course, is the COVID situation. That’s impacted the way we do business. It’s impacted our patients. It’s impacted all of you dramatically. I thought I’d give a little update on what’s happened in our over 2000 clients. As you know, we serve a population of men between fifty and ninety plus our oldest patient just turned one hundred. This is a high risk group. Men are at higher risk for COVID complications and as we get older, particularly over 80, the complication rate goes up and the mortality rate goes up. We’ve actually lost one patient to COVID in our whole practice in 2020. It was an unfortunate individual that was traveling in Egypt in the January, February timeframe and when he came back to the United States he was ill. This was before people were really clear of what was going on, went to the hospital with pneumonia, and unfortunately passed away. We’ve had other patients, perhaps a dozen or so that have caught the COVID. They’re sort of evenly divided between men who really report that it wasn’t much of anything at all and others, the other half, they got pretty darn sick, a really bad flu. None of them fortunately had to go to the hospital. They all recovered. This is rather remarkable considering our vulnerable demographic. It shows that if people are careful and they isolate, they wash their hands, keep their hands off their face, most people aren’t going to catch this. Of course, when I talk to patients, I’m impressed by how much isolation is going on out there, how much care they are taking. Many men have come to the office and said that I am the first out of the house experience that they’ve had in 2020. So people are being very careful and clearly being careful does work. Liz: [02:49] Yeah. I remember early on in the pandemic, our office had way less traffic and was almost empty. Now it seems like things are picking back up and people are checking back in on their health. Dr. Scholz: [03:01] We’ve had a bunch of people come to the office who maybe had some cold symptoms, everyone’s on edge, and we’ve tested them for the COVID antibody to see if they did indeed have previous exposure. These tests are almost always coming back negative. We’re told by the scientists that these tests are probably 80% to 90% accurate. They’re not 100% accurate when you do the antibody test. That’s the test to determine if you’ve had previous exposure to COVID. We believe, and some people disagree, that if you’ve had previous exposure and your antibody test is positive, that it’s as if you’ve had a vaccination and you can’t catch COVID and you can’t transmit it. That of course would be good news. We’ve tested several hundred people now and almost all of them are negative. The ones that are positive are the ones that told us previously that they knew they had COVID. These antibody tests confirm it. This is a different test than the nasal swab, where doctors are trying to determine if you actively have the COVID virus. Those tests are more accurate, perhaps approaching 99% accurate. Patients who think that they have symptoms need to find a place to get tested, to rule in or rule out whether they are infectious. After they’ve been sick, they want to be tested again, to make sure that the infection risk has gone away. Liz: [4:38] We’ve had inquiries about where to get tested. We usually just send whoever across the street to Cedar Sinai, and they’ll do it there. The turnaround on these test is quick enough that people can just wait for their results and they should know within an hour. All right, Dr. Scholz, I think the biggest information about COVID right now is news of a vaccine. I think one thing a lot of people are concerned about is how quickly this has developed vaccines usually take years, if not a decade to get developed. This has happened within a year, which is pretty incredible. Do you think it will be safe? Dr. Scholz: [05:15] So there’s been debates, everyone’s heard them, that will the vaccine work, will it have durability? At this point, the preliminary science suggests that it will work and it will have durability. There’s three different companies that are putting forth a new product. The hope is that by the end of the year we will be having people getting vaccinated. Of course, there’ll be selective preference for the elderly people in healthcare. How this is all going to roll out is a big question. But it seems at this point, there’s no doubt that by early 2021 a vaccine is to be available and it will be effective. Liz: [06:00] It is changing really quickly. I know we were just talking about this last week and when I went back to review, I almost had to research it all again. So it’s important to stay up to date on this. Dr. Scholz: [06:14] Yeah everything that we do in the oncology realm and in this realm as well is predicated on what we call a risk-benefit ratio. We give dangerous medicine sometimes in oncology, but we are treating life-threatening cancers and sometimes rolling the dice and taking a chance with a treatment makes a lot of sense if the disease is much worse and very dangerous. So it’s going to be different for different people, for myself as a physician, meeting people all day long and basically in a high-risk situation, it seems to me that I’ll be lining up early for the vaccination. For those of you out there that are comfortable in your isolated state and are willing to sustain that, 2020 showed us that people can remain pretty safe if they’re very careful, but the social isolation is taking a big cost in our patients’ mentalities, their lifestyles, their social lives. It’s been painful and difficult when people have to make a personal choice as to whether the relatively small risk of getting a vaccine is too great to consider as opposed to continuing in their existing lifestyle. We’ll have more information every month as this vaccine rolls out as to how dangerous or how many risks there’ll be associated with it. That is unknown at this point. But as a lot of people are going to be getting this vaccine, we should have very good information within a few months. I think one last thing to emphasize is that we’ve learned that the COVID virus complication rate goes up astronomically in men over 80. Men over 80 and the elderly are at the very highest risk and mortality rates start to become very significant in this group. It would seem to me that these elderly men are going to want to try and get a vaccine, even if there are some risks associated with the vaccine, because the virus for them is very dangerous. Liz: [08:22] So another paradigm shift that occurred this year was the shift towards telehealth. It seems like about half of our visits now are being conducted over the phone or via FaceTime or Skype. Dr. Scholz: [08:36] This has been a really big change. In trying to understand it and wrap my brain around it, it seems that it’s a radical shift in accessibility. In the past, phone visits were discouraged because the impetus was to get people into the office and be able to bill for your services. Now, both private and Medicare insurance has essentially mandated insurance coverage for telehealth. This has rapidly been accepted by patients due to the accessibility, the ease of communication. It’s even been nice to be able to take off my face mask and see the body language of my patients and communicate non-verbally with Skype and FaceTime. In the office employees, patients alike are all wearing masks and we’re making eyes at each other, using our voices and trying to overcome the muffled communication that has become routine now in our lives. Liz: [09:44] I think something else that the telehealth has brought is connection. Right now people are feeling kind of anxious and separated. If they are skipping doctor’s appointments to avoid waiting rooms and being close to other people, it’s such a great way to catch up on the latest in prostate cancer and catch up with you. Your face appears in their living rooms and it’s like they’re right in your office. Dr. Scholz: [10:10] Yeah it is very personal. It’s as you all have experienced now, your face fills the screen and it’s not as disconnected as people might think. The risk to patients with telehealth is obviously reduced. But one component of the way we do medicine, of course, is blood tests, injections, and treatments, and certain in office visits are still unavoidable. If patients go to a remote facility for blood testing, they’re still going to have some contact. But so far as has been demonstrated, the COVID infection rate for our patients has been very low, whatever precautions people are taking seem to be working quite well. One thing about telehealth is it appears to be here to stay. I’ve talked to high-level insurance people about the future of telehealth asking, will it go away once the COVID risk disappears? The general consensus is that there’s no going back. This increased accessibility seems to be the future of medicine. Liz: [11:19] So even big topics that are maybe a little more involved or confusing are easily addressed over Skype or FaceTime or a phone appointment. Let’s start talking about a couple of those that are new developments for 2020. Dr. Scholz: [11:34] We already covered PARP inhibitors but they, being brand new treatments for advanced prostate cancer, merit a quick review. PARP is an enzyme that helps repair DNA. About 10% to 15% of men with advanced prostate cancer have a mutation that causes their DNA repaired to work less efficiently. One application of this mutation, which is called BRCA, is that there’s a little higher risk of getting prostate cancer. The men who get prostate cancer that have BRCA tend to have a more aggressive form. The PARP inhibitors exploit this mutation and men that have this mutation respond much, much better to PARP inhibitors. PARP inhibitors are pills that make it even more difficult to replicate or duplicate DNA. These already impaired cancer cells then die more easily and more quickly than your normal cells of your body. We’re always looking for a differential effect with cancer treatments, a treatment that focuses more on the cancer, then your cells killing cancer without causing a lot of side effects. So the medicines we’re talking about are Olaparib and Rucaparib two new pills that help men with BRCA mutated cancer and are now FDA approved. Liz: [13:01] These two approvals really highlight how important using genetic testing is. This will help men with prostate cancer find treatments that may have only been FDA approved for another cancer. Doing genetic testing is very easy. It can be accomplished with a mouth swab or a blood test, and it’s almost always covered by insurance. So we briefly covered some updates and genetic testing. Let’s review the PSMA PET scan really quick. Dr. Scholz: [13:32] We did a whole podcast on this because it’s a big breakthrough. Most of you have heard of it by now, but for the first time we can accurately locate the prostate cancer wherever it is in the body and the prostate and the lymph nodes in the bones with one single scan. This scan may be five times more accurate, ten times more accurate than any previous scan that was available. What a wonderful addition to our diagnostic armamentarium. This is going to have an impact for people with early stage disease, late stage disease. Unfortunately, the FDA has not yet approved it, but we’re anticipating approval within the next six months or so. In that situation, it will be covered by insurance and it will be very popular. Liz: [14:18] Some companies are investigating using PSMA as a therapeutic target rather than just a diagnostic target. Dr. Scholz: [14:28] Exactly. So the diagnostic scanning is incredibly useful reconnaissance for figuring out where the cancer is and helping design a treatment protocol. But if we’re able to accurately locate the cancer with these scans, wouldn’t it be possible to use this same target, to make therapies stick to the surface of the cancer cells? There are two very exciting types of treatment. One we’ve talked about before uses an antibody to stick to PSMA and draw a high energy radioactive molecule right next to the cancer cell and kill the cancer cell. This is called Lutetium- 177. The phase three trials in prostate cancer have been completed. We’ve had patients on trial or outside the country, get this treatment with very nice responses. We’re talking about a treatment for men that have already had chemotherapy, become hormone resistant to Zytiga and Xtandi, and who perhaps have limited treatment options getting nice PSA declines with relatively little, if any, toxicity. There is a PSMA antibody on the salivary glands, so some people get a little bit of a dry mouth. Some people with radiation, it can cause some lowering of blood counts, but for the most part, there’s practically no side effects with dramatic responses to Lutetium-177. The phase three trials are completed and they’re waiting for them to mature to validate that there is a survival advantage. Once that happens and the study results are released, the FDA has six months to approve or disapprove the treatment for broad spectrum dispersal amongst the population for therapy and insurance coverage. Liz: [16:14] So it seems like there’s a lot to look forward to with PSMA being used as a diagnostic test as well as its role in therapeutics, especially for men with advanced prostate cancer. There are a couple immunotherapies that are exciting on the horizon. Can we talk a little bit about those? Dr. Scholz: [16:36] Amgen has developed a connector molecule that instead of linking a radioactive moiety to the antibody that clips to PSMA, it’s sort of like a pheromone tag that draws in your T-cells. I don’t know how many of you are familiar with how the immune system works, but the soldier cells of the immune system are called the T-cells and the T-cells are the component of your immune system to go in and attack the cancer cells and kill them directly. Theoretically, if you can get the T-cells in close approximation with the cancer cells, they will attack and kill them. There is new technology from Amgen, a very large pharmaceutical company, that has developed this and is doing phase two testing in men with advanced prostate cancer and responses are indeed occurring. So the patients are injected with a substance that clips onto PSMA i.e. the surface of the cancer cells and draws the patient’s immune system close to the cancer cells so that it will attack it. Liz: [17:49] As you can see, there’s so much information about prostate cancer this year alone, we’ve covered focal therapy, brachytherapy, radiation, immunotherapy, chemotherapy; the list goes on and on. So looking forward, it’s important to always stay in touch and stay up to date and keep sharing and keep listening. You might find it useful to go back and review old episodes of PROSTATE PROS. You can find us on your favorite player. So Dr. Scholz, another exciting thing 2020 was the 10th anniversary of your first book Invasion of the Prostate Snatchers. Something you may not know is that this year, Dr. Scholz and I have been working hard to update his first book Invasion of the Prostate Snatchers. So about 10 years ago, when the first edition was published, it was really the first introduction to active surveillance. I think Dr. Scholz received a little flak from that, and now it’s more widely accepted, but with that, there’s still a lot of the industry that patients need to be careful of. That includes over-treatment. That includes dangers of surgery and random biopsies. So we’re really looking to restart the conversation, and get patients to be their own advocates. Dr. Scholz: [19:16] There’s a theme in the prostate cancer world that you have to educate yourself. I hope that both of my books encourage people to do their own research, to take responsibility for their health and to double check the information, rather than just accepting the first pitch you hear from a doctor. Prostate cancer is big business. It’s a multi-billion dollar world, and people are trying to make a profit. Ethically, no doubt, there’s so many gray areas in the prostate cancer world. You need to double-check and you need to find the original, basic information that leads you to the truth. Liz:  [19:59] So this new completely rewritten second edition of Invasion of the Prostate Snatchers will be out in 2021.  We’re really excited to share it with you.  Telehealth has really connected us this year, and we’re looking forward to staying connected in 2021.  Remember to tune into the podcast and share with your friends.  If you have any topics you want us to cover in the upcoming year, you can email us at podcast@prostateoncology.com.

Dr. Lynn Seeley is the CEO of Myovant Sciences. She is an endocrinologist with over 20 years of drug development and biopharmaceutical company leadership experience. Prior to joining Myovant, she served as Chief Medical Officer of Medivation for 10 years where she led the development of XTANDI® (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer. Today Lynn and Donnica are taking a break from talking about the pandemic to go back to the basics of the ladies' room:  period talk. Women don't talk about their periods enough so often women are silently suffering from really harsh period pains. Lynn encourages women to be more open about their periods so that they can know their period better. So they open up and share their own period horror stories so you can feel ready to share your own!

Here are the links for everything discussed in Episode 14. Xtandi added indication Xeljanz XR added indication Approval of Padcev for urothelial cancer Approval of Vyondys 53 for Duchenne Muscular dystrophy Vascepa approval to reduce the risk of cardiovascular events. Connect with The Rx Daily Dose:Twitter      Instagram      YouTube      Linkedin       WebsiteEmail: therxdailydose@gmail.comConnect with Ian Parnigoni PharmD. on social media:Twitter       Instagram       Linkedin  ★ Support this podcast on Patreon ★

Hormone therapy, or Testosterone Inactivating Pharmaceuticals, work to either stop testosterone’s production or limit testosterone’s activity in promoting prostate cancer growth. These powerful anti-cancer drugs can put men with prostate cancer in remission for years and in some cases even decades! Discover hormone therapy treatment protocol and monitoring, get insight to hormone resistance, and learnContinue reading

In this podcast Anson Tharayanil, a Meical Science Liaison from Genomic Health, Inc. talks with Joel Nowak about their test, the Oncotype DX ARV-7 Nucleus Detect Test for men with castrate resistant metastatic prostate cancer. The test is used to determine if the second line hormone therapies like Xtandi, Zytiga and Erleada will be an effective treatment for men who have the diagnosis of prostate cancer that has left the gland (if they have metastases) and are no longer responding to the first line hormone (ADT) treatments like Lupron, Eligard, Prostap and Casodex. Initially, Anson gives an explanation about what is castrate resistant metastatic prostate cancer so that everyone can clearly understand the disease process that happens as prostate cancer progresses. Afterwards, he describes how the Oncotype DX ARV-7 Nucleus Detect Test works so that you can know if you are a candidate for any of the new second line hormone therapy drugs (Zytiga, Xtandi and Erleada). Anson also describes how it might be possible to re-sensitive some men who have stopped responding to thee drugs. Support the show (https://www.cancerabcs.org/new-page-2/)

PharmaPills - Pillole dal farmaceutico: Novità, Curiosità e Lavoro dal mondo del farmaceutico. A cura di Stefano LagravineseIn questa puntata parliamo di:Aziende: Merck, AstraZeneca, Teva, Kolinpharma, EMA, Pfizer, Astellas, Opis.Persone: Donato Bonifazi (AICRO), Fabio Giordano (AICRO), Stefano Marini (AICRO), Antoinette Van Dijk (AICRO).Nuove terapie: olaparib, fremanezumab, Xtandi, nivolumab, ipilimumab, palbociclib.Patologie: emicrania, tumore alla prostata, tumore del polmone, tumore al seno.Lavoro: GCP auditor, Clinical Trial Administrator, Clinical Development and Operations Senior Manager.Ogni mercoledì alle h 12.00 su Spreaker.com e iTunes.Seguici su: www.telegram.me/pharmapillswww.facebook.com/pharmapills/Hai un dispositivo Apple? Seguici e abbonati al podcast tramite la app iPod http://nelfarmaceutico.link/pharma-apple

PharmaPills - Pillole dal farmaceutico: Novità, Curiosità e Lavoro dal mondo del farmaceutico. A cura di Stefano LagravineseIn questa puntata parliamo di:Aziende: Merck, AstraZeneca, Teva, Kolinpharma, EMA, Pfizer, Astellas, Opis.Persone: Donato Bonifazi (AICRO), Fabio Giordano (AICRO), Stefano Marini (AICRO), Antoinette Van Dijk (AICRO).Nuove terapie: olaparib, fremanezumab, Xtandi, nivolumab, ipilimumab, palbociclib.Patologie: emicrania, tumore alla prostata, tumore del polmone, tumore al seno.Lavoro: GCP auditor, Clinical Trial Administrator, Clinical Development and Operations Senior Manager.Ogni mercoledì alle h 12.00 su Spreaker.com e iTunes.Seguici su: www.telegram.me/pharmapillswww.facebook.com/pharmapills/Hai un dispositivo Apple? Seguici e abbonati al podcast tramite la app iPod http://nelfarmaceutico.link/pharma-apple

Today in FirstWord:

How those living with mCRPC, a fatal form of prostate cancer, can explore this new treatment option.

How those living with mCRPC, a fatal form of prostate cancer, can explore this new treatment option.

Today in FirstWord:

New option available for men with advanced prostate cancer

New option available for men with advanced prostate cancer