Final phase 3 trial results confirm a survival benefit with the immunotherapy cemiplimab (Libtayo) when used for the second-line treatment of recurrent or metastatic cervical cancer.
Cemiplimab is already approved in the United States for certain patients with non-small cell lung cancer and for the treatment of basal cell carcinoma. The drug's manufacturer, Regeneron, is now awaiting approval for the cervical cancer indication, having announced in September that Libtayo had been accepted by the US Food and Drug Administration for priority review (which means a decision within 6 months).
The results in recurrent cervical cancer were published online today in the New England Journal of Medicine.
They come from the phase 3 randomized, open-label EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 study comparing cemiplimab given at a dose of 350 mg every 3 weeks with investigator's choice of single-agent chemotherapy in 608 women who had disease progression after first-line, platinum-based chemotherapy.
Overall survival at median follow-up of 18.2 months was significantly longer among those in the cemiplimab group than in the chemotherapy group (median of 12.0 vs. 8.5 months; hazard ratio for death, 0.69). Progression-free survival was also improved (HR for disease progression or death, 0.75).
"In our randomized trial involving patients with recurrent cervical cancer who had disease progression after platinum-containing therapy, cemiplimab showed a benefit with respect to overall survival that was significant and clinically meaningful. The results suggested that some women with recurrent cervical cancer may benefit from therapy with cemiplimab," the authors conclude.
These newly published results mirror those released last year after a second planned interim analysis, as the trial's independent data monitoring committee recommended at that time that the trial be stopped early on the basis of efficacy. Those interim findings, as reported by Medscape Medical News, were presented last May at a virtual plenary session of the European Society of Medical Oncology and concurrently published online in Annals of Oncology.
Objective response rates (ORRs) in the overall population were 16.4% vs 6.3% in the cemiplimab and chemotherapy groups, respectively. The ORRs were 18% vs 11% in patients with PD ligand-1 expression ≥1% vs those with PD-L1 expression <1%, respectively.
Grade 3 or higher adverse events occurred in 45% vs 53.4% of those in the cemiplimab and chemotherapy groups, respectively.
"Cemiplimab can provide a new standard of care treatment option for this population associated with a very poor prognosis," first author Krishnansu S. Tewari, MD, commented when presenting the interim findings. Tewari is director of the Division of Gynecologic Oncology, Obstetrics and Gynecology at the University of California, Irvine,
Discussant Mansoor Raza Mirza, MD, chief oncologist at Copenhagen University Hospital, Copenhagen, Denmark, added that the "impressive" interim results marked "the beginning of a new era in cervical cancer drug development and improved patient outcomes."
The EMPOWER-Cervical trial was funded by Regeneron Pharmaceuticals, Inc and Sanofi. Tewari reported financial relationships with Genentech, Tesaro, Clovis, AstraZeneca, Merck, AbbVie, Morphotek, and Regeneron Pharmaceuticals, Inc.
N Engl J Med. Published online February 9, 2022. Abstract
Sharon Worcester is an award-winning medical journalist at MDedge News, part of the Medscape Professional Network.
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Cite this: Confirmed: Cemiplimab Ups Survival in Recurrent Cervical Cancer - Medscape - Feb 09, 2022.