Sanofi/Regeneron’s ‘Breakthrough’ PD-1 Positive In Skin Cancer

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Sanofi and Regeneron reported new topline data for their midstage checkpoint inhibitor in a certain form of skin cancer. The data focused on 82 patients with advanced cutaneous squamous cell carcinoma (CSCC), a type of skin cancer less deadly than melanoma.

Although, full details have not been shared, the PD-1 therapy indicated an overall response rate of 46.3%. The companies pointed out that median duration of response “had not yet been reached at the data cut-off point,” and added that 32 of 38 responses are ongoing. The single arm test was dubbed EMPOWER-CSCC 1. The drug, cemiplimab, is presently progressing through submission status in the U.S., which is anticipated to be complete in 2018. EMA submission is also on track for the same period.

“EMPOWER-CSCC 1 was initiated in 2016 and has enrolled rapidly, underscoring the serious unmet need in advanced CSCC,” said Elias Zerhouni, M.D., president of global R&D at Sanofi.

“We look forward to working with regulatory agencies globally to bring this important therapy to advanced CSCC patients as quickly as possible. We continue to rapidly advance a broad development program to evaluate cemiplimab both as monotherapy and combination across a number of solid tumor and blood cancers” Zerhouni added.

Currently not one of the PD-1/PD-L1 drugs have been approved to treat CSCC, a disease responsible for annual deaths between 4,000 and 8,000 people in the U.S. For those diagnosed with advanced CSCC, there is no standard of care and limited treatments.

Sanofi announced the submission of nine regulatory submissions over the next year and a half, including cemiplimab, and “at least 10 pivotal phase 3 studies expected to begin over next 12 months”.

In Wednesday’s R&D update, the biotech said: “Sanofi is committed to re-building its position in oncology and has made major progress in the past two years. This strategy is starting to deliver and we anticipate 14 new proof-of-concept studies to be initiated, four potential proof-of-concept readouts, six phase 1 starts and three BLA/ MAA submissions in 2018.”

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