Dr. Tewari on the Trial Design With Cemiplimab in Cervical Cancer

Krishnansu Tewari, MD, associate professor, Division of Gynecologic Oncology, University of California, Irvine, discusses the trial design with cemiplimab (Libtayo) in recurrent or metastatic cervical cancer.

The GOG 3016/ENGOT-cx9 is a randomized, phase III trial that is examining the use of cemiplimab, an anti—PD-1 agent, versus investigator's choice chemotherapy in patients with recurrent or metastatic cervical cancer. Investigators are hoping to accrue approximately 450 patients across 8 different countries.

Patients do not have to be PD-1/PD-L1—positive to be eligible for the trial, though it is being tested for, notes Tewari. If the study is positive, it will need to be reviewed by the FDA. The trial is being conducted in partnership with Regeneron, the manufacturer of the anti–PD-1 agent. Investigators are hoping that if the trial reports positive findings, it will approved by the FDA as a second-line therapy for patients with recurrent and metastatic cancer who have either progressed on platinum or platinum plus bevacizumab (Avastin).

In September 2018, the FDA approved the PD-1 inhibitor for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation.