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Biotech / Medical : Regeneron Pharmaceuticals
REGN 695.46+2.0%3:59 PM EST
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To: Miljenko Zuanic who wrote (2770)10/28/2019 9:52:22 PM
From: CuttingEdge Bio  Read Replies (3) of 3557
 
REGN scaled back development efforts on ant-CTLA4/PD-1 combination, while we now have TWO confirmation that adding anti-CTLA4 to anti-PD1(L1) is beneficial for NSCLC.

This oversimplifies things to the point of drawing an unsupported conclusion.

NONE of these companies have shown that CTLA-4 blockade added to the anti-PD-1 mechanism has benefit in efficacy OVER PD-1 by itself in lung. (or aCTLA-4 +aPD-1 + chemo vs. PD-1 + chemo). The ONLY way any company can hope to market a CTLA4 + PD1 combo in the lung setting is by showing its efficacy is better than PD1 pathway alone. As of now, MRK's result was so good that it has set a new standard. PD1 + chemo in first line has taken over. They hit on OS and they did this with strong HR ratio's.
For some reason BMY PD-1 hasn't done as strongly as MRK PD-1 in first line lung as Part 1a of Checkpoint227 trial failed its primary endpoint of Op + chemo vs. chemo.

AZN is also limited here by the additional problem that aPD-L1 in lung looks weaker than aPD-1. They likewise showed no benefit of aPDL1+aCTLA4 over aPD-L1 alone, and what they did show so far is merely PFS. But not OS, not yet at least. They are chasing a ghost because the standard of care has become PD-1 + chemo in first line, and in SOME cases maybe PD-1 mono with >50% positive for PDL1 expression, but I think most consider the combo to have best efficacy. So why would it be meaningful to show that your PDL1 combo plus CTLA4 with chemo is better than chemo alone if you are lucky enough to have the PFS translate to OS, when your numbers are probably going to be weaker than MRK's anyway and therefore look like an inferior and less safe regimen, and why would a doc want to add a 3rd drug without knowing it adds benefit?
REGN was smart to go after the MRK leadership indications that dominate and will dominate the marketplace. By demonstrating similar-looking benefit in the same setting, it could become an additional option to do the same thing without sacrifice of efficacy or safety as in the other cases. If later it can be shown that adding CTLA4 on top makes for better efficacy than PD1 alone, great, but no one has demonstrated that and several have already failed to do so and redesigned their trials midstream and afterwards because of it.
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