FDA

Sanofi, Regeneron earn ‘breakthrough’ status for a fast-track drug out to prove PD-1 dominance

Can an experimental PD-1 drug still offer breakthrough potential?

The FDA today said yes, handing out its breakthrough therapy designation for the newly dubbed cemiplimab (REGN2810) from Regeneron and its longtime Big Pharma partner Sanofi.

Regulators handed out the title — good for opening doors at the FDA for development executives in a rush — in metastatic cutaneous squamous cell carcinoma and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma.

In an early-stage cohort with only 26 patients, the PD-1 drug was associated with a 46% overall response rate and a 69% disease control rate. The FDA, which now has considerable experience in shepherding the first 5 PD-(L)1 to their first approvals, did not overlook the implications here.

With the help of regulators, cancer-focused biopharma companies have revolutionized oncology programs. In this case, Regeneron and Sanofi are already gearing up for a regulatory filing within the next 7 months — on a new therapy already also in a late-stage study as a first-line drug for non-small cell lung cancer and a Phase II in metastatic and locally advanced basal cell carcinoma.

Researchers for these two companies tell me that this therapy has the potential to prove that a PD-1 is inherently superior to PD-L1. (Sanofi R&D chief Elias Zerhouni is reluctant to go that far at this point, but is happy to hint it may prove so.)

If they’re right, the companies have a chance of leapfrogging checkpoints already on the market as they look to grab the lead in key cancer types. Today’s BTD helps keep them in a spotlight at a time that PD-(L)1s have been multiplying in the clinic, with a host of companies looking to develop an in-house drug they can use for their own combinations.

Unless these drugs can clearly distinguish themselves from each other, as Sanofi and Regeneron plan to do, then we could be on the verge of seeing a commoditization of checkpoints.

Billions of dollars in revenue is at stake.


Image: Elias Zerhouni, Sanofi’s president of global R&D, speaks in Paris last year Vincent Isore/IP3/Getty


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