Survival with Cemiplimab in Recurrent Cervical Cancer

This phase 3 trial evaluated the efficacy and safety of cemiplimab, a PD 1 inhibitor, compared to investigator’s choice chemotherapy in 608 women with recurrent cervical cancer who had progressed after first line platinum based therapy. Patients were randomized 1:1 to receive cemiplimab (350 mg every 3 weeks) or chemotherapy (pemetrexed, gemcitabine, topotecan, irinotecan, or vinorelbine). The primary endpoint was overall survival (OS). Results showed a significant improvement in median OS with cemiplimab (12.0 months vs. 8.5 months; hazard ratio [HR] 0.69; 95% CI, 0.56–0.84; P<0.001). The survival benefit was consistent across histologic subtypes (squamous-cell carcinoma: HR 0.73; adenocarcinoma/adenosquamous carcinoma: HR 0.56). Progression-free survival (PFS) also favored cemiplimab (HR 0.75; P<0.001), and objective response rates were higher (16.4% vs. 6.3%). Grade ≥3 adverse events occurred in 45.0% (cemiplimab) vs. 53.4% (chemotherapy). The study concluded that cemiplimab significantly improved survival and had a manageable safety profile, supporting its use as a second-line treatment for recurrent cervical cancer.

This phase 3 trial evaluated the efficacy and safety of cemiplimab, a PD 1 inhibitor, compared to investigator’s choice chemotherapy in 608 women with recurrent cervical cancer who had progressed after first line platinum based therapy. Patients were randomized 1:1 to receive cemiplimab (350 mg every 3 weeks) or chemotherapy (pemetrexed, gemcitabine, topotecan, irinotecan, or vinorelbine). The primary endpoint was overall survival (OS). Results showed a significant improvement in median OS with cemiplimab (12.0 months vs. 8.5 months; hazard ratio [HR] 0.69; 95% CI, 0.56–0.84; P<0.001). The survival benefit was consistent across histologic subtypes (squamous-cell carcinoma: HR 0.73; adenocarcinoma/adenosquamous carcinoma: HR 0.56). Progression-free survival (PFS) also favored cemiplimab (HR 0.75; P<0.001), and objective response rates were higher (16.4% vs. 6.3%). Grade ≥3 adverse events occurred in 45.0% (cemiplimab) vs. 53.4% (chemotherapy). The study concluded that cemiplimab significantly improved survival and had a manageable safety profile, supporting its use as a second-line treatment for recurrent cervical cancer.