A phase III trial evaluating cemiplimab, compared to chemotherapy in recurrent/metastatic cervical cancer patients who had previously been treated with chemotherapy will be stopped early after an interim analysis found compelling efficacious results with the anti PD-1 therapy.
Including women with either squamous cell carcinoma or adenocarcinoma, the study reports a median overall survival of 12 months in patients who received cemiplimab, compared to 8.5 months with chemotherapy, resulting in a 31% reduction in the risk of death.
When assessed by histology type, the reduction in the risk of death was most profound in those with adenocarcinoma, with a risk reduction of 44%, whilst patients with squamous cell carcinoma had a reduction of 27%. The drug, developed by Sanofi and Regeneron, will be put forward for regulatory approval later this year. “Recurrent or metastatic cervical cancer is notoriously difficult to treat and has no approved standard of care after first-line chemotherapy”, says Israel Lowy, senior vice president, translational and clinical sciences, oncology at Regeneron. He adds “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”.