Second-Line Cemiplimab Yields Benefit in Improved OS vs Chemotherapy in Cervical Cancer
Treatment of cervical cancer patients who had disease progression after first-line platinum-containing chemotherapy with the programmed cell death 1 (PD-L1)-blocking antibody cemiplimab was associated with statistically significantly improved median overall survival (OS) compared to chemotherapy (12 months vs 8.5 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.84; two-sided P <.001), according to results from a phase 3 trial.
“An objective response (OR) occurred in 18% (95% CI, 11 to 28) of the cemiplimab-treated patients with PD-L1 expression greater than or equal to 1% and in 11% (95% CI, 4 to 25) of those with PD-L1 expression of less than 1%,” wrote lead author Krishnansu Tewari, MD, University of California-Irvine Medical Center, and colleagues.
In the study, investigators enrolled 608 women who were assigned (1:1) to receive either cemiplimab (350 mg every 3 weeks) or the investigator’s choice of single-agent chemotherapy. Cemiplimab is approved to treat skin cancers.
The OS benefit was consistent in subjects with squamous-cell carcinoma, adenocarcinoma, and adenosquamous carcinoma.
Progression-free survival was also longer in the cemiplimab group than in the chemotherapy group (hazard ratio for disease progression or death, 0.75; 95% CI, 0.63 to 0.89; two-sided P <.001). In the overall population, an OR occurred in 16.4% (95% CI, 12.5 to 21.1) of the patients in the cemiplimab group, as compared with 6.3% (95% CI, 3.8 to 9.6) in the chemotherapy group.
Adverse events (AEs) were also decreased in the treatment arm; grade 3 or higher AEs occurred in 45% of the patients who received cemiplimab and in 53.4% of those who received chemotherapy.
Source:
Tewari K, Monk B, Vergote I, et al. Survival with Cemiplimab in Recurrent Cervical Cancer. N Engl J Med. 2022 Feb 10;386(6):544-555.
