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Flying solo for a change, Sanofi says isatuximab scored an important success in first PhIII myeloma study

Maybe Sanofi can develop a major new oncology drug on its own.

Early Tuesday the pharma giant announced the successful — topline — Phase III outcome for isatuximab, its anti-CD38 treatment for multiple myeloma. Researchers said the drug hit the endpoint on progression-free survival among patients who had been treated with at least two earlier therapies.

There’s no data yet, but it will be closely watched when Sanofi does post the results as it hustles a new drug application to regulators.

John Reed

It’s hard to overestimate the importance of isatuximab for Sanofi. The Paris-based pharma giant has relied heavily on Regeneron for drug discovery and development. Isatuximab is an in-house program that’s coming to the goal line several years after a round of oncology work ended in bitter defeat at Sanofi, forcing a reorganization. And its long-running alliance with Regeneron is coming to a close.

This myeloma therapy stands as a potentially important effort in its own right, as well as evidence that the company — with an R&D organization now under John Reed — won’t always have to lean on partners for new blockbusters.

So far so good.

ICARIA-MM is one of four ongoing Phase III studies involving this drug. It’s also being studied as a combination therapy with their checkpoint cemiplimab, with investigators pursuing signs that the add-on could have an effect on PD-1 resistance.


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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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