Phase 3 trial of cemiplimab monotherapy in advanced cervical cancer stopped early for positive result on overall survival

Regeneron Pharmaceuticals, Inc and Sanofi announced positive results demonstrating an overall survival (OS) benefit from the Phase 3 trial investigating the PD-1 inhibitor cemiplimab (Libtayo) monotherapy compared to chemotherapy, in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic. The trial will be stopped early based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), and the data will form the basis of regulatory submissions in 2021.

“Libtayo monotherapy is the first medicine to demonstrate an improvement in overall survival in women with recurrent or metastatic cervical cancer following progression on platinum-based chemotherapy in a Phase 3 trial,” said Krishnansu S. Tewari, MD, Professor and Director of the Division of Gynecologic Oncology at the University of California, Irvine and a trial investigator. “This landmark clinical achievement will bring hope to women with advanced cervical cancer who are often younger than patients with other cancers. This is reflected in this trial where the average age was 51.”

Read the full press release here.