Regeneron, Sanofi are ready to debut the 6th PD-1/L1. Is it still possible to stand out from the growing crowd?

Regeneron $REGN and Sanofi $SNY rolled out an update on their PD-1 checkpoint cemiplimab this morning, demonstrating that the promising early data they had seen on a high response rate for a deadly skin cancer remained intact for close to half of all the patients enrolled in the pivotal Phase II trial.

Investigators came up with a 46.3% ORR for advanced cutaneous squamous cell carcinoma in the study, which is being taken to regulators in search of a quick OK for what will likely be the world’s sixth PD-1/L1 therapy to hit the market. According to recent research from the Cancer Research Institute, there are another 49 PD-1/L1 checkpoints in clinical development, with hundreds more in preclinical research.

Israel Lowy, Regeneron

This one, though, has been held up by the research team as potentially superior to much of the rest of the field. Top investigators in the program have highlighted their belief that PD-1 is a fundamentally superior approach than PD-L1 — though they have yet to prove that. The two big partners are also once again relying on Regeneron’s famous antibody factory to stand out from the crowd with a checkpoint that won the FDA’s breakthrough designation.

There’s still no final take on the duration of the response, with Sanofi saying that 32 of 38 responses among the 82 patients enrolled are continuing.

It’s no coincidence that Sanofi arranged to declare the pivotal data today, right at the beginning of its annual R&D day. For the pharma giant it’s a chance to demonstrate that it has the R&D firepower needed to come up with important new therapies — even if much of the innovation is still coming from its partners at Regeneron.

Skeptics, though, aren’t seeing anything new with today’s updates. Still, Sanofi can use this PD-1 to create its own combos as it sets the stage for a renewed R&D effort on the oncology front, after some serious setbacks forced an earlier reorganization. But Baird’s Brian Skorney says that at this point no-one should think a launch will be easy, or quickly profitable. He notes;

Sales of Keytruda and Opdivo are on track for $3.8B and $4.8B, respectively, this year. Tecentriq, the third to market two years later, is on track for about $500M, while Bavencio and Imfinzi, both approved this year, have sold close to nothing. Competing in the major PD-(L)1 indications such as melanoma, NSCLC, etc. will therefore likely be very difficult. Though we don’t disagree that front-line NSCLC is a huge opportunity, the plethora of disappointing data in NSCLC with approved agents presents an unrealistically high hurdle for management to expect to easily cross.

Israel Lowy, Regeneron’s lead scientist on the program, had this to say:

This is the largest prospective study ever conducted in this disease, and we are pleased that many people were able to achieve deep and durable responses with cemiplimab monotherapy. The high and durable response rates seen in this study are particularly notable given that the study enrolled patients regardless of biomarker status.

The rolling submission will be wrapped in Q1.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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