Sanofi and Regeneron’s PD-1 inhibitor Libtayo has demonstrated positive overall survival (OS) results in a Phase III trial in advanced cervical cancer.
The Phase III trial, evaluating Libtayo (cemiplimab) compared to chemotherapy in recurrent/metastatic cervical cancer patients who had been previously treated with chemotherapy, will be stopped early based on a recommendation made by the Independent Data Monitoring Committee (IDMC).
The trial included women with advanced cervical cancer who had either squamous cell carcinoma or adenocarcinoma.
In the overall population, the median survival for patients receiving Libtayo was 12.0 months compared to 8.5 months for chemotherapy – a 31% reduction in the risk of death.
For patients with squamous cell carcinoma, Libtayo reduced the risk of death by 27% and for adenocarcinoma patients, the risk of death was reduced by 44%.
The IDMC recommended stopping the trial following a protocol-specified interim analysis, which found a highly significant effect on OS among patients with squamous cell carcinoma.
Sanofi and Regeneron said in a statement that the data will form the basis of regulatory submissions in 2021.
In addition, detailed results from the trial will also be presented at an upcoming medical meeting.
“Recurrent or metastatic cervical cancer is notoriously difficult to treat and has no approved standard of care after first-line chemotherapy,” said Israel Lowy, senior vice president, translational and clinical sciences, oncology at Regeneron.
“This trial, which enrolled patients regardless of their PD-L1 status, demonstrated that Libtayo helped patients with recurrent or metastatic cervical cancer live longer after progression on prior chemotherapy,” he added.