Merck News
Those slippery rascals at Merck have the fawning, BP loving, FDA right where they want them... Highly toxic Keytruda plus highly toxic chemo equals - yeah lots of patient toxicity and marginal extensions of life expectancy. Too bad our, thus far proven, safe and effective little bio constructs can't get the same accelerated consideration. G.B.
"Last night, Merck (MRK) announced that not only had it filed for regulatory approval for its combination of Keytruda and chemotherapy but that the FDA had accepted the filing. The news caught the market by surprise, and has sent share of Merck soaring–they’re up 4.6% at $62.65 at 10:20 a.m. Bernstein’s Tim Anderson explains why the announcement was such a big deal:
Before [yesterday's] news, it seemed that Merck’s chemo combo filing would not likely occur until Q4-2017, contingent on successful completion of the ongoing phase 3 trial, KEYNOTE-189. Today’s disclosure therefore appears to pull the timeline forward by ~9-12 months.
The basis for the filing is the impressive Keynote-021 data (cohort G) that was presented in October-2016 at ESMO. This was only a phase 2 trial, but importantly it was randomized, meaning Keytruda+chemotherapy was compared to chemotherapy alone. An “all comer” population was studied and results (specifically, response rate and PFS) were strikingly positive for the combination, with efficacy seen across all levels of PDL1 expression…There was no overall survival benefit but the interpretation of this particular finding is challenged by the degree of patient “crossover” that occurred. By contrast, Checkmate-012 – the primary basis for investor enthusiasm towards CTLA4 combinations – has had no true comparator arm which likely makes it un-fileable (at least by itself; Bristol-Myers Squibb (BMY) continues to explore other ways to file Opdivo+Ipilimumab sometime in 2017)."