Monday, October 24, 2016

[U] 'Twas Expected -- For The Night Before Christmas, 2016 -- But It Arrived Tonight: Keytruda® NSCLC First Line Approval

UPDATED -- 10.25.2016 @ 7 AM EDT: In early morning (wee hours) commentary, a smart anonymous viewer has pointed out that I am not giving enough credit here. This is materially good news. As is the overall "beat" on Q3 2016 results -- just announced. I expect Merck will rise, on the NYSE this morning. And Dr. Tim Anderson of Sanford Bernstein concurs with my anonymous commenter -- he thinks this shifts the entire map in immuno-oncology in Merck's favor. I certainly think it makes the testing a non-issue -- since all NSCLC patients will now have the test first. Thanks again go out to my smart, fair and balanced comment crew! [So, to celebrate (the season's early arrival!), I've set those cute lil' elves a-workin', and they've given us an all new graphic, at right. And. . . speaking of early Christmases -- go Cubs go, tonight! End, updated portion.]

Going into earnings in the morning, Kenilworth has an early Christmas present -- very early, indeed.

The FDA's expected "approve by" date was to be on or before December 24, for this indication. But it arrived after the NYSE close, this evening. Two full months early -- which is a life saver for many many a cancer patient (as my commenter rightly points out). Good news for Merck -- even if the label will only be for patients whose lung cancer masses expresses high levels of a certain protein. [I would expect some off-label use, though -- truth be told.] It puts a real crimp in Roche's plans to dominate in the space (as its offering will run in third place, in lung cancer, now). BMS will be fine, but this is decidedly good Merck news, per Reuters:

. . . .Merck & Co Inc on Monday said the U.S. Food and Drug Administration has approved its immunotherapy Keytruda for use in certain previously untreated lung cancer patients, making it the only approved first-line treatment.

The drug has been approved for treating metastatic non-small cell lung cancer (NSCLC) patients with high-levels of a protein known for suppressing the immune system called PD-L1. . . .

Even so, I do not think this single announcement fundamentally changes the game, in the wide azure ocean of immuno-oncology, overall -- at least not in the ways that some pundits are claiming. Except, of course, in one quarter of first-line NSCLC patients. And that may well dissipate in time -- with more data. But none of us have that data yet. So. . . we wait -- for data from BMS and Roche. G'night, to all of good will. . . as I saw my own version of a toddling set of present(s), this morning. . . smile.



Anonymous said...

not doing it justice - first time in 40 years there is a drug available in first line NSCLC that gives patients a fighting chance to spend another christmas with grandchildren and live life with some dignity - Merck did the right thing by selecting those patients that can really benefit from this new therapy.

Anonymous said...

I'm sure you've seen this but, in case you didn't:

condor said...

Thanks so much. Indeed I did.

And for reasons I cannot disclose, I will not be making comment on it.

So each reader should follow Anon.'s thoughtful link, and draw their own conclusions.

Smile -- and Namaste!

Anonymous said...

The approval was early for KN-026 but in line with the PDUFA date for KN-010 approval, which was also approved at the same time. Kudos to the FDA for working flexible and quickly to approve all 3 of the key items (Keytruda approval for 1L NSCLC in high expressers, 2L NSCLC for all expressers, and the 200mg fixed dose for 1L/2L NSCLC).