KENILWORTH, N.J. October 13, 2021 Eastern Daylight Time
The FDA approved combining Merck & Co.'s anti-PD-1 therapy Keytruda (pembrolizumab) plus chemotherapy, with or without Roche's Avastin (bevacizumab), for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1 with a combined positive score (CPS) ≥1.
The approval is based on the Phase III KEYNOTE-826 trial, which showed that adding Keytruda to chemotherapy, regardless of Avastin use, extended survival in first-line cervical cancer by eight months, compared to standard treatment, according to updated findings unveiled at the European Society for Medical Oncology (ESMO) congress last month. The hazard ratios for overall survival and progression-free survival, the trial's dual primary endpoints, were 0.64 and 0.62, respectively. Baynes called the 36% reduction in the risk of death "compelling."
The combination was also associated with an overall response rate (ORR) of 68%, compared to an ORR of 50% for chemotherapy, with or without Avastin.
Additionally, the FDA converted the accelerated approval of KEYTRUDA as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test, to a regular approval based on confirmatory data from KEYNOTE-826. This approval was originally granted in June 2018 based on results from the KEYNOTE-158 trial.