Positive Libtayo Phase III data in advanced cervical cancer

13 May 2021

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) and French partner Sanofi (Euronext: SAN) have announced positive results from the Phase III trial of their PD-1 inhibitor Libtayo (cemiplimab) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy.

The results, which were presented Wednesday at the European Society for Medical Oncology (ESMO) Virtual Plenary, make Libtayo the first immunotherapy to demonstrate an improvement in overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) compared to chemotherapy in second-line advanced cervical cancer. The data will form the basis of regulatory submissions in 2021.

"In this Phase III trial, Libtayo demonstrated a significant improvement in overall survival in women with advanced cervical cancer after progression on chemotherapy, reducing the risk of death by 31% compared to chemotherapy in the overall population," said Dr Krishnansu Tewari, Professor and Director of the Division of Gynecologic Oncology at the University of California, Irvine and a trial investigator.

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