Another agnostic approval.
#Pembrolizumab
🧬 #TMB⬆️
🟢TMB⬆️ cutoff >=1️⃣0️⃣

Though I’m overall very supportive of agnostic approvals overall, not sure if TMB⬆️ is the same across tissue types.
@US_FDA #OncoAlert #PrecisionMedicine
https://seekingalpha.com/news/3583617-fda-oks-mercks-keytruda-for-second-application-based-on-biomarker?source=tweet https://seekingalpha.com/news/3583617-fda-oks-mercks-keytruda-for-second-application-based-on-biomarker
TMB⬆️ is part of the story. Cutoff of 1️⃣0️⃣ not sure if that even is applicable to a lot of GI tumors including MSI⬆️. Even within MSI⬆️ seems like the cutoff appears to be a lot higher in responders🆚non-responders. The 10-18ish in the intermediate TMB ❓benefit at least in GI.
Even the patients accrued don’t meet definition of agnostic:

“158 trial accrued patients with anal, biliary, cervical, endometrial, salivary, thyroid, or vulvar carcinoma, mesothelioma, a neuroendocrine tumor, or small cell lung cancer.”

🚩Also baffling: OS worse in TMB⬆️.
More on spectrum of #cancers in #Keynote158 & the tale of crossing curves similar to most #Immunotherapy studies. ✅tail of prolonged benefit noted in a subset of patients. As noted ☝🏽🧵 concern is “agnostic” approval is missing:
❌breast
❌colorectal
❌NSCLC
❌Prostate
@GerkIvan
More on spectrum of #cancers in #Keynote158 & the tale of crossing curves similar to most #Immunotherapy studies. tail of prolonged benefit noted in a subset of patients. As noted concern is “agnostic” approval is missing:breastcolorectalNSCLCProstate @GerkIvan
More on spectrum of #cancers in #Keynote158 & the tale of crossing curves similar to most #Immunotherapy studies. tail of prolonged benefit noted in a subset of patients. As noted concern is “agnostic” approval is missing:breastcolorectalNSCLCProstate @GerkIvan
More on spectrum of #cancers in #Keynote158 & the tale of crossing curves similar to most #Immunotherapy studies. tail of prolonged benefit noted in a subset of patients. As noted concern is “agnostic” approval is missing:breastcolorectalNSCLCProstate @GerkIvan
More on spectrum of #cancers in #Keynote158 & the tale of crossing curves similar to most #Immunotherapy studies. tail of prolonged benefit noted in a subset of patients. As noted concern is “agnostic” approval is missing:breastcolorectalNSCLCProstate @GerkIvan
You can follow @pashtoonkasi.
Tip: mention @twtextapp on a Twitter thread with the keyword “unroll” to get a link to it.

Latest Threads Unrolled:
Those who think consciousness raising & movement building are disconnected, or even a distraction from electoral politics have not paid attention to the history of social change.In this thread, we
Read more
The 2020s will be known as the Remote Work decadeA few predictions of what is likely to emerge[ a thread ] Third Space: Office and Working from Home will
Read more
1/29: Have you ever had a concept explained to you that helps frame complex issues you’ve been wrestling with and opens your eyes to new possibilities? A concept that I
Read more
By continuing to use the site, you are consenting to the use of cookies as explained in our Cookie Policy to improve your experience.