Immuno-oncology, Regulatory

Regeneron/Sanofi circle October 28 on the calendar as the FDA begins a speedy review of the world’s 6th PD-1/L1 checkpoint

A Regeneron/Sanofi team has a target date for launching the world’s 6th PD-1/L1 checkpoint inhibitor. And while they may be late to the growing league of rivals — dominated by Bristol-Myers Squibb and Merck — they plan to enter with a market splash, with considerable assistance from FDA regulators who are steel keen to expand the field.

The FDA has agreed to give the PD-1 cemiplimab a priority review, say the biopharma partners, offering a PDUFA date of October 28. That comes on top of the breakthrough therapy designation from last fall, underscoring that regulators will move fast here. The developers are pushing hard for an approval to use the drug as the first of the PD-1/L1 therapies for metastatic cutaneous squamous cell carcinoma, a non-melanoma skin cancer, who are not eligible for surgery.

That deadline gives the Regeneron/Sanofi team time to see if they can make a splash at ASCO in a few weeks with data from their single-arm Phase II trial. The EMA started their review earlier this month.

Assuming they get a quick OK — and given the experience regulators have with PD-1/L1s and the rep these developers are bringing to the table, that’s easy to do —  you can expect the team to start looking to make up for lost time as they expand the use of cemiplimab. Both Regeneron and Sanofi still have high hopes for the overall market opportunity, as a lineup of majors like Roche, AstraZeneca and Pfizer/Merck KGaA grapple with the two top players for a slice of a blockbuster market.

John Reed

At the beginning of the year Regeneron and Sanofi committed an extra billion dollars to their war budget for cemiplimab. It represents the latest in a series of big programs from the partners, who are winding down their antibody alliance. And it will likely line up as one of John Reed’s first wins as he replaces Elias Zerhouni at the helm of Sanofi’s global R&D team.

Behind them is a growing tsunami of PD-1/L1 cancer checkpoints, with a host of new combos looking to expand their use and widen their impact. The Cancer Research Institute ran a study that found 164 PD-1/L1s in the pipeline, from preclinical through marketing stages. Novartis has one in development solely for in-house use. And we may find a few thrown in as low-pried commodities, making checkpoint 2.0 more important than ever for the leaders.

Regeneron/Sanofi plan to be on the inside, looking out.


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