Trial of Libtayo stopped early on strong Phase III data

Having just last month notched up two US regulatory approvals for Libtayo (cemiplimab), French pharma major Sanofi (Euronext: SAN) and US biotech Regeneron (Nasdaq: REGN) today had more positive news on their PD-1 inhibitor.

They said the Phase III study as a monotherapy compared to chemotherapy in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic, 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 III trial,” said Dr Krishnansu Tewari, Professor and director of the Division of Gynecologic Oncology at the University of California, Irvine and a trial investigator, adding: “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 the trial where the average age was 51.”