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Biotech / Medical : Regeneron Pharmaceuticals

REGN 681.78

+1.0%

3:59 PM EST

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To: Miljenko Zuanic who wrote (2782)	11/7/2019 11:33:28 AM
From: CuttingEdge Bio	Read Replies (1) of 3557

It would seem that in all the haste to pare down their clinical program and satisfy the rapacious Wall St and the angry investor base about their R&D spend and their EPS numbers, The "part 1" trial was sabotaged. (Remember the wholesale changes made to Cemi clinical program as of JPM 2018). Because in all other cases so far (AZN Mystic, as well as BMY Opdivo+Yervoy) the PD1 (or PDL1) + CTLA4 combos were not significant on PFS but in the end they were stat sig on OS. So cutting part 1 short based on Response rates not looking superior or based on these competitor failures in PFS endpoints, has now left REGN unable to pursue that Part 1 design any further without massive delay/restart. (At least from what I can gather. Correct me if I'm wrong). That design was robust and informative - Chemo vs. Cemi+chemo, vs. Cemi+Yervoy+chemo, but now it's something less than informative because its endpoint is only ORR. The ORR could be non significant but it tells nothing about the OS, which is what matters and seems to be helped by CTL4 combos.

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