Dr. Tewari on Trial With Cemiplimab in Recurrent or Metastatic Cervical Cancer

Krishnansu Tewari, MD, associate professor, Division of Gynecologic Oncology, University of California, Irvine, discusses the GOG 3016/ENGOT-cx9 trial in patients with recurrent or metastatic cervical cancer.

Women with advanced cervical cancer have typically had no options, says Tewari. For thirty years, gynecologic oncologists were not able to make a significant dent in overall survival until they studied bevacizumab (Avastin). These results were reported at the 2013 Annual ASCO Meeting. That led to the regulatory approval of bevacizumab for patients with metastatic and recurrent cervical cancer in approximately 60 countries around the world, states Tewari.

However, there is no option for patients who progress on bevacizumab. There is a lot of interest in immunotherapy, adds Tewari. GOG 3016/ENGOT-cx9 is an open-label, multi-national, randomized, phase III trial of cemiplimab, an anti—PD-1 agent, versus investigator's choice of chemotherapy. The study will accrue approximately 450 patients, and 60 patients have already enrolled on the study.

The trial hopes to help women who have progressed on bevacizumab or who were not good candidates for bevacizumab. These patients are in need of a second-line therapy that is effective and tolerable as chemotherapy alone in the second-line setting is very ineffective.