Merck and Co Inc (MRK)

[DewDiligence]

MRK—Keytruda-monotherapy BLA in TMB-high tumors has 6/16/20 PDUFA (with FDA priority review):

https://www.mrknewsroom.com/news-release/oncology-newsroom/merck-receives-priority-review-fda-second-application-keytruda-pembro

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.