As Dr. Vinay Prasad takes over the very important Center for Biologics Evaluation & Research at the FDA, It's important to note that this is the first Digital Opinion Leader Physician to hold this role, (and the first digital opinion leader to hold any major role in the FDA) A prior FDA Commissioner Dr. Scott Gottlieb was a healthcare stock picker similar to Jim Cramer. (SELL SELL SELL !!), but his depth of content doesn't compare to Dr. Prasad's over 500 professional publications and wealth of social media content dissecting cancer clinical trials and FDA decisions.
As a Digital Opinion Leader, Dr. Prasad has been a frequent content creator and contributor across multiple platforms including X, YouTube, Substack, and his plenary podcast platform. As such, many of his thoughts about currently approved drugs and their associated FDA registration trials are available on the web. Many Pharma Leaders may be scrambling to determine Dr. Prasad's sentiments on their products, trials, and their competitors. For healthcare providers and professionals in Oncology, here is a breakdown of Dr. Prasad's major sentiments for key Breast Cancer Trials. I'll follow up with other tumor types this week.
NOTE: these are YouTube Video Clips below. Although the thumbnails are the same, the clips are different time points in the YouTube Videos
Breast Cancer Trials:
Kisqali (ribociclib) by Novartis
Ribociclib plus Endocrine Therapy in early Breast Cancer
FDA Approval, September 17, 2024:
Plenary Session at ASCO24
I"f you can fit a laser pointer between the curves...."
"That's a very marginal difference in a surrogate endpoint"
"...For most of the curve you can't even fit a laser pointer"
"...You start with 2500 people and you show me outcomes for 12 people..."
"...there may be differences in the outcomes that have nothing to do with the treatment, that have to do with who happened to stay and who happened to go."
"...This whole trial goes from one where you can barely fit a laser pointer to one where you can't fit a laser pointer"
"The effect size was already so marginal, that it doesn't take much to make it wither away entirely"
"Some of these ultra low risk women are going to take this for three years, take huge risks in infection, and have almost no reduction in IDFS"
"But it's not a well done study. It's got all these problems,"
ENHERTU (Trastuzumab deruxtecan, T-DXd) by AstraZeneca, Daiichi-Sankyo
Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer
Presented at ASCO22 with a standing ovation!
FDA Approval: August 6, 2022
"Endocrine Therapy for Hormone Receptor Negative Breast Cancer 23% 40%, WTF!"
What's going on that endocrine therapy's being given here?"
"Either there's something wrong with the math or something wrong with these docs"
Lack of Data Transparency:
"How can I deconstruct a paper when you don't let me have any of the facts? OK, it's very difficult."
"If only there was a moment in Breast Cancer history when we learned that progression free survival wasn't a good endpoint in metastatic breast cancer..."
"Nested vs adjacent subgroup analyses..."
"So these are the primary endpoints and they are going to hit the ball out of the park on all of them."
"The ILD, the ILD. It's no joke. It's no joke. 12% ILD..."
"Nausea, 73%, and this is in a clinical trial where you know, these patients are getting exquisite management and care for nausea"
"I think these toxicity issues may play a big role, especially if this wants to claim all this market share."
"Budgetary impact is gonna blow the budget, and 12% ILD, how much will ILD management count?
"Why did someone Hormone Receptor Negative get Hormonal Therapy?"
"Standing Ovation I think is wrong"
"I don't see any red flags here"
"It's super active, that response rate is blowing it out of the water. So, they don't have any reason to hide, they can tell us what went on."
Verzenio (abemaciclib) by Eli Lilly + fulvestrant
Abemaciclib Plus Fulvestrant in Advanced Breast Cancer After Progression on CDK4/6 Inhibition
Presented at ASCO24
"If you just look at the curves it's pathetic"
"It's a pretty pathetic result"
"The BICR has way more censoring"
"This tells me that investigators are trigger happy to call progression"
"The investigator just wants to get them off this f'n trial and get them on something else"
There is toxicity."
"People want to be off this g'dam study and get them on something that's actually working"
More explanation from Dr. Olivier(from the video discussion) regarding postMONARCH and the censoring issue. Click the Tweet to Follow the Thread.
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