Wednesday, March 18, 2015

Merck Shares Rise 2 Per Cent -- After Announcing "Late-Breaking" NSCLC Keytruda® Data Presentation: Mid April 2015

While we don't yet know how the data reads out, we may infer fairly safely that it will put Kenilworth in the hunt for an NSCLC FDA label expansion/approval -- on Keytruda® -- in late 2015 or early 2016. And that is a good thing, given the immense burden that lung cancer represents -- as a disease state.
Expect more later, as I am road-blogging here. Here is a bit from the press release, out of Kenilworth at around 4 PM EDT today:

. . . .The NSCLC data will be the first presentation of new efficacy and safety findings for KEYTRUDA from 495 patients, including validation of PD-L1 expression (abstract #CT104). These data are from the largest, multi-center Phase 1b (KEYNOTE-001) study of an anti-PD-1 therapy. With the mesothelioma findings (abstract #CT103), data evaluating KEYTRUDA will have been presented in eight different types of cancer. . . .

Graphics will follow. Even if the NSCLC data doesn't allow for/get granted a priority review at FDA, this is materially good news. Maybe Merck is now only six to nine months behind BMS -- maybe. Not nine to twelve. And maybe a little under six, if FDA grants Merck a priority review designation. We shall see.

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