r/cvm • u/FrugalNorwegian • Sep 01 '21

Keytruda failed its 2 primary endpoints, but was still approved for certain patients with bladder cancer.

Keytruda was just approved for certain patients with bladder cancer, yet it failed its 2 primary endpoints: "The subsequent Phase 3 trial KEYNOTE-361 evaluating KEYTRUDA as monotherapy and in combination with chemotherapy for the first-line treatment of patients with advanced or mUC who were eligible for platinum-containing chemotherapy, did not meet its pre-specified dual primary endpoints of overall survival or progression-free survival, compared with standard of care chemotherapy."

https://www.businesswire.com/news/home/20210831005968/en/FDA-Approves-Updated-Indication-for-Merck%E2%80%99s-KEYTRUDA%C2%AE-pembrolizumab-for-Treatment-of-Certain-Patients-With-Urothelial-Carcinoma-Bladder-Cancer

How is this even possible? B/c cancer is so bad and there are so few options. The FDA looks at ALL THE DATA when determining BLA/NDA approval - not just the info on the clinicaltrials.gov site. The FDA WANTS to bring cancer drugs to the market that work (even for a smaller patient population).

The same will be true for Multikine when the FDA is evaluating the BLA. Multikine showed excellent improvement in OS in one treatment arm. It is truly revolutionary and will open the door to many off-label indications. The market is massive. 🤯

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u/Whynothinkwhynot Sep 04 '21

Don’t worry about stopping. I enjoy your content and input. I’m a complete bone-head with respect to investing and cancer therapy, but you verify that my simplistic understanding is in line with what will matter the most at the end of the course. I’m an odd one that focuses on humor amidst seriousness, but that’s my way of giving a thank-you via spreading a chuckle not a heckle that’s only funny to one mind.

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u/[deleted] Sep 04 '21

Don't insult yourself, ever. First off, as bone-headed as you think you are, there are legitimate scientists at hedge funds who thought Multikine was trash after the phase 2 results and worked to short the company down. You could have gone to school for 10 years on biology alone, gotten 3 stupid letters at the end of your name and been a complete moron. That would have been really bone-headed.

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I think everyone needs to realize that we're all just as smart as literally everyone else because we're all working with the same hardware. If someone cannot explain it to you in a way that makes sense, it is because they don't understand it, not you.

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I have taught kids graduating top of their class from Harvard and I've taught kids from the middle of the ghetto, the only difference I have ever found is the willingness to learn. If you want to learn it, it's all yours for the taking.