Controversy over cemiplimab in NSCLC?! What now? Is REGN full of BS and HYPING Cemp intentionally and prematurely? Or, maybe they have *cracked the door* in Keytruda PSYCHOLOGICAL dominance in NSCLC??????
Because of my large finance interest in REGN (although, in all my 25 years of bios-investment never did I putted my personal interest over objectivity), my view may be distorted and unrealistic. Whoever have different or opposite view, is welcome to participate in discussion.
Keytruda FDA label, P54,P51/2, 1L NSCLC : accessdata.fda.gov
KEYNOTE-024 data
Data point to mPFS of 10.3 v 6.0 and mOS of 30.0 v 14.2 months. ORR was 45% v 28% with CR of 4% v 1%
KEYNOTE-042 data:
mPFS 7.1 v 6.4, mOS 20.0 v 12.2 months, ORR 39% v 32%.
In K-042, TPS>50%, CR rate for Keytruda is EQUAL to CHEMO, and not much difference (only 7%) in ORR!!!! So, DURATION OF RESPONSE and probably DURATION OF STABLE DISEASE, is main factor that contribute in mPFS and mOS observed benefit! General observation note, Keytruda CR rate frequently is lover that for Opdivo. Fact or fiction????
Note: K-042 is *maybe* more representative than K-024 on Keytruda clinical benefit in 1L NSCLC, PDL1>1%, >50%!.
In Cemp update PR (https://investor.regeneron.com/news-releases/news-release-details/regeneron-provides-updates-phase-3-libtayor-cemiplimab ), REGN reported *Investigator* ORR data from first 361 subjects after min 6 months follow up. I am sure that per protocol they did by blinded Independent review committee PFS-interim for those subjects, in addition to OS-interim. By event they are about 1/3 of the target, still too early to demonstrate *extreme* OS benefit, mostly generated from *DURATION* component of the anti-PD1 clinical activity.
While ORR data suggest equal or better efficacy v Ketruda, ORR is not surrogate end-points for frontline NSCLC. Nonetheless, if ORR is accompanied with *duration*, it is hard to project trial not achieving OS benefit at second interim. I will assume that investigator’s ORR data are close to IRC-data.
Without further details it is worthless to compare Cemp to Keytruda in NSCLC, but add data from CSCC to this interim NCLC-tidbit, I think that they did *crack the door*.
Market is sketchy, untrusty (BMS-fiver), and unfair.
Time (8/9-2020) will tell where REGN stand, ….they need this to work demonstrating that *me-too* approach is not just *me-too*!
For the chemo-combo NSCLC, part one, ORR was not reported. This ORR data would be indicative of the combo activity in PDL1+ positive, and data should be available at ASCO-2020. |
