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.
