According to Bradley J. Monk, MD, FACOG, FACS, cemiplimab achieved better response and a longer overall survival compared with chemotherapy in patients with cervical cancer.
Bradley J. Monk, MD, FACOG, FACS, gynecologic oncologist, Arizona Oncology, explains the rationale for the EMPOWER-Cervical 1 trial and the positive study results.
0:07 | Even though pembrolizumab [Keytruda] got approved in June of 2018, that was a single-arm accelerated approval with a very low response rate. And so, there was a need really to test the hypothesis what the activity of single agent chemotherapy would be in that second-line setting, and whether single agent checkpoint inhibitors would truly be more active than physician’s choice chemotherapy. And that's exactly what GOG 3016 did, otherwise known as EMPOWER.
0:40 | This is a randomized phase 2 trial done internationally of cemiplimab 350 milligrams every 3 weeks or investigator’s choice chemotherapy. And it worked. Immune therapy better than physicians choice chemotherapy in the second-line setting. In fact, not only is it better in response rate, it is better in overall survival, with an improvement from 8.5 months with physicians choice chemotherapy to 12 months with some cemiplimab, which has a hazard ratio of point six nine.
1:18 | Now, the controversy is what about PD-L1 status? You can't know. EMPOWER was not designed to test that. And so, as a result of that the primary endpoint and empower was squamous cell tumors, because we thought that there was more PD-L1 expression in squamous tumors, and we thought that the activity would be better. Well, the reality is that some cemiplimab works regardless of PD-L1 status in both squamous tumors, and adenocarcinomas.
Editor’s Note: On January 28, 2022, the supplemental biologics license application for cemiplimab as treatment of metastatic cervical cancer was voluntarily withdraw by the developer.