Prasad’s “deceit,” plus, ODAC’s tough decision against biomarker-based progression assessment

In last week’s issue of The Cancer Letter, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, each had a big story: Jacquelyn wrote about the April 30 meeting of the Oncologic Drugs Advisory Committee, and Paul wrote about Vinay Prasad’s inaccurate claims on his CV. In this week’s episode of The Cancer Letter Podcast, Jacquelyn and Paul talk more about these stories. In a document dated June 23, 2023, Prasad, who is described as a social media star, inaccurately claims to have served as a “Member” of “U.S. President’s Cancer Panel” between 2016 and 2017. “The President's Cancer Panel is one of those interesting institutions created in the National Cancer Act of 1971, which is, and its function is to inform the president of the United States about barriers towards implementation of the National Cancer Act of 1971 and the National Cancer Program,” Paul said. “And one of the great honors in oncology is to be placed on this panel and it's had some really illustrious members. The first chair of the president's cancer panel was none other than Ben Schmidt. I mean, I'm pretty sure that Mrs. Lasker was on it. I mean, this is a big deal—it's also three members at a time, and they're actually advising the president of the United States. “So, when you have three of them, there's not much room to hide.” Later in the episode, Jacquelyn and Paul talked about AstraZeneca’s new drug application for camizestrant, a next-generation oral selective estrogen receptor degrader, or SERD, in metastatic breast cancer, appearing before the FDA Oncologic Drugs Advisory Committee. The application, with a Breakthrough Therapy designation from FDA, an ASCO plenary, and publication in The New England Journal of Medicine under its belt, might have seemed set to sail smoothly through the FDA approval process. But ultimately, the application got a thumbs down from the committee. In this disease setting, patients develop resistance to first-line treatment, and “a primary way it develops is through this one mutation called ESR1,” Jacquelyn said. “Basically, this mutation, we know, is a resistance mutation and it leads to progression. What we don't know is that between that mutation being acquired and the progression actually happening on scans, or radiographic progression, we don't know whether it's better for patients to continue on the aromatase inhibitor or to switch to a new drug. “So, that's basically the big question about this trial, about this drug and this approach, this biomarker-driven progression approach. And that's why this was such a bigger question than just the ODAC. This approach is going to be coming up in other indications. It's a technological advancement that is coming for the field, whether we're ready or not.” Stories mentioned in this podcast include: Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC Vinay Prasad’s CV inaccurately claims past membership on the President’s Cancer Panel J. Craig Venter’s work was foundational to cancer advancement of the past 25 years Trump changes pick for Surgeon General, nominating Nicole Saphier A transcript of this podcast is available: https://cancerletter.com/podcastc/202...