The application seeks accelerated approval of KEYTRUDA monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) =10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options.
I wrongly thought TMB as a cancer biomarker was dead after BMY made a mess of it in the CHECKMATE-227 study (#msg-153308881). I doubt that MRK knows anything consequential about TMB that BMY doesn’t; however, MRK might have better results than BMY did because the trial described above has a simple design, compared to the unwieldy monster that BMY’s CHECKMATE-227 turned into.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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