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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (2782)	11/7/2019 9:56:49 AM
From: DewDiligence_on_SI	Read Replies (1) \| Respond to of 3557

ORR together with duration of response is indeed a good predictor of OS for I-O regimens. This is somewhat tautological, however, insofar as OS is itself a duration metric.

To: Miljenko Zuanic who wrote (2782)	11/7/2019 11:33:28 AM
From: CuttingEdge Bio	Read Replies (1) \| Respond to 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.

To: Miljenko Zuanic who wrote (2782)	11/7/2019 11:49:28 AM
From: Miljenko Zuanic	Respond to of 3557

RE: anti-CTLA4 IO contribution to 1L NSCLC, is there any space left? Early enthusiasm disapeared as data from trials start to role in: ncbi.nlm.nih.gov and, there is additional concern... ncbi.nlm.nih.gov Severe toxicity pushed toward regime where Ipi is taight controled...still, data were short of expectation. Now, investigator (even with latest bit positive outcome) are rolling out anti-CTLA4 arm. for instance, in cemiplimab second 1L NSCLC ( clinicaltrials.gov ), ipi arm was not included in part-2 (randomized part) of the chemo-combination. In all, without good biomarker(s) that can predict benefit of the aCTLA4, due to severe toxicity and in same cases worse outcome...it may slowly disappear as option. BMY is looking at triple IO regime (214 + nivo + Ipi), including NSCLC (in addition to RCC, melanoma and UC), MRK is still silent on their aCTLA4 regime/molecule.