Libtayo is the first immunotherapy to demonstrate an improvement in overall survival in advanced cervical cancer, as well as progression-free survival and objective response rate, compared to chemotherapy
Improvements in overall survival were seen in the overall population and both squamous cell carcinoma and adenocarcinoma subgroups
Additionally, the Phase 3 trial found significant differences in patient-reported outcomes favoring Libtayo over chemotherapy
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the presentation of positive results from the Phase 3 trial investigating the PD-1 inhibitor Libtayo® (cemiplimab) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy. The data were shared as part of a European Society for Medical Oncology (ESMO) Virtual Plenary and add to previously reported data showing an improvement in overall survival (OS) with Libtayo compared to chemotherapy. The data will form the basis of regulatory submissions in 2021.
"In this Phase 3 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 Krishnansu S. Tewari, M.D., Professor and Director of the Division of Gynecologic Oncology at the University of California, Irvine and a trial investigator. "Improvements in progression-free survival and objective response rate were also demonstrated in the overall population compared to chemotherapy. Taken together, this landmark trial – which enrolled patients regardless of PD-L1 expression status – helps support the use of Libtayo as a potential new second-line treatment for women with advanced cervical cancer who face a poor prognosis and limited treatment options."
https://finance.yahoo.com/news/positive-phase-3-libtayo-cemiplimab-173000783.html
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