Cemiplimab has been shown to significantly improve survival compared to physician’s choice of chemotherapy in patients with recurrent cervical cancer following first-line platinum-based chemotherapy.1 This article presents the final overall survival (OS) analysis from the phase III randomised EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial.2
METHODS
The trial enrolled 608 patients who had disease progression after first-line platinum containing chemotherapy, regardless of their programmed cell death-ligand 1 (PD-L1) status. They were randomly assigned (1:1) to receive either cemiplimab (350 mg every three weeks) or investigator’s choice of single-agent chemotherapy. The primary endpoint was OS.
RESULTS
After a median follow-up of 47.3 months, median OS was 11.7 months in the cemiplimab group compared to 8.5 months in the chemotherapy group (HR[95% CI]: 0.67[0.56–0.80], p< 0.00001). The survival benefit of cemiplimab was observed in both PD-L1 positive and negative populations, despite a higher proportion of patients with PD-L1 <1% having a poor performance status in the cemiplimab arm compared to the chemotherapy arm (61.4% vs 47.9%). Objective response rate was higher with cemiplimab compared to chemotherapy (17.1% vs 6.3%). The safety profile of cemiplimab remained consistent with prior data, with comparable rates of adverse events between treatment arms. Grade ≥3 adverse events occurred in 47% and 54% of patients treated with cemiplimab and chemotherapy, respectively.
CONCLUSIONS
The final analysis confirms that cemiplimab provides a sustained survival benefit over chemotherapy in recurrent cervical cancer after progression on first-line platinum-based therapy, regardless of PD-L1 expression. These findings support the use of cemiplimab as a second-line treatment option for patients with recurrent cervical cancer.
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