Replies to post #207850 on Biotech Values

[DewDiligence]

It's mystifying that MRK's KEYNOTE-021 data were not accepted for a compendia listing (#msg-126043338).

[ciotera]

Re: MRK

Even with a broad label, patients will still need to be tested to see if they can get Keytruda mono (if they have >50% expression). The OS curve in KN021G did not separate - so, whether one uses carbo+pem upfront followed by PD1 or combines them together in 1L may not matter. And considering that some patients can get BEV+carbo+pem, followed by BEV/PEM maintenance (and their only chance to get it would be in 1L), it's not going to be easy for PD1+chemo to penetrate 1L (esp. <1%/PD-L1 negative). People like to preserve options for sequencing, so it's a tough ask to shoot both bullets (platinum and PD1) together in 1L. I better be getting a big OS separation for this.

[DewDiligence]

MRK—FDA approves Keytruda/chemo in first-line NSCLC—regardless of PD-L1 expression level:

$MRK FDA approves Keytruda chemo combo in 1L NSCLChttps://t.co/hgP8hGAPIq
H/T @TradeHawk $BMY $AZN $RHHBY pic.twitter.com/FnWrTK1ABd

— Andy Biotech (@AndyBiotech) May 10, 2017

Today was the PDUFA date.

[DewDiligence]

MRK withdraws EU application for Keytruda/chemo in first-line NSCLC:

http://www.mrknewsroom.com/news-release/corporate-news/merck-provides-update-european-application-keytruda-pembrolizumab-combin

MRK is -3% in AH trading and was -6% during regular trading—a cumulative loss of 10% relative to yesterday’s close, making today MRK's worst day since Vioxx.

Perhaps the EMA news leaked. Requesting withdrawal of an application is the polite way in which the EMA rejects an application.

MRK received FDA accelerated approval in this indication in May 2017 (#msg-131249474).

[DewDiligence]

MRK—Keytruda hit on OS/PFS in KEYNOTE-189 interim analysis:

https://www.businesswire.com/news/home/20180116005680/en/Mercks-KEYTRUDA-pembrolizumab-Significantly-Improved-Survival-Progression-Free

KEYNOTE-189 tested chemo ± Keytruda is first-line non-squamous NSCLC for patients with any PD-L1 status. The hazard ratio for OS/PFS and other details will be presented at an unspecified medical conference (probably ASCO).

Success in KEYNIOTE-189 allows MRK to convert the accelerated approval from the small KEYNOTE-021G study (#msg-131249474) into a full FDA approval.