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Regeneron : Data On Libtayo Shows Longer Durability, Higher Complete Response Rates In Skin Cancer

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi announced new, longer-term data for PD-1 inhibitor Libtayo from a pivotal Phase 2 trial in advanced cutaneous squamous cell carcinoma (CSCC), the deadliest non-melanoma skin cancer.

The results demonstrate both longer durability and higher complete response rates than previously reported. In addition, the data make up part of the largest and most mature prospective clinical dataset in patients with metastatic CSCC (mCSCC) or locally advanced CSCC who are not candidates for curative surgery or radiation.

"The three-year follow-up data demonstrate significant long-term outcomes with Libtayo, which is now standard-of-care for patients with advanced CSCC in many countries," said Danny Rischin, Director, Department of Medical Oncology at Peter MacCallum Cancer Centre, Victoria, Australia.

Results from the pivotal Phase 2 trial showed 46% of patients experienced substantial tumor shrinkage following Libtayo treatment, with a median time to response of 2 months. Furthermore, more patients (16%) saw their tumors disappear completely over time compared to previous analyses.

Among patients with metastatic disease who had the longest available follow-up, 20% of patients have now achieved a complete response, increasing from 7% in the 2017 primary analysis.

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