Survival with Cemiplimab in Recurrent Cervical Cancer.
The New England journal of medicine
california; sjo; orange; sjh; Adenocarcinoma; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, Immunological; Biomarkers, Tumor; Carcinoma, Adenosquamous; Disease Progression; Female; Humans; Middle Aged; Neoplasm Recurrence, Local; Programmed Cell Death 1 Receptor; Quality of Life; Survival Analysis; Uterine Cervical Neoplasms
BACKGROUND: Patients with recurrent cervical cancer have a poor prognosis. Cemiplimab, the fully human programmed cell death 1 (PD-1)-blocking antibody approved to treat lung and skin cancers, has been shown to have preliminary clinical activity in this population.
METHODS: In this phase 3 trial, we enrolled patients who had disease progression after first-line platinum-containing chemotherapy, regardless of their programmed cell death ligand 1 (PD-L1) status. Women were randomly assigned (1:1) to receive cemiplimab (350 mg every 3 weeks) or the investigator's choice of single-agent chemotherapy. The primary end point was overall survival. Progression-free survival and safety were also assessed.
RESULTS: A total of 608 women were enrolled (304 in each group). In the overall trial population, median overall survival was longer in the cemiplimab group than in the chemotherapy group (12.0 months vs. 8.5 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.84; two-sided P
CONCLUSIONS: Survival was significantly longer with cemiplimab than with single-agent chemotherapy among patients with recurrent cervical cancer after first-line platinum-containing chemotherapy. (Funded by Regeneron Pharmaceuticals and Sanofi; EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 ClinicalTrials.gov number, NCT03257267.).
Women & Children
Obstetrics & Gynecology
Tewari, Krishnansu S; Monk, Bradley J; Vergote, Ignace; Miller, Austin; de Melo, Andreia C; Kim, Hee-Seung; Kim, Yong Man; Lisyanskaya, Alla; Samouëlian, Vanessa; Lorusso, Domenica; Damian, Fernanda; Chang, Chih-Long; Gotovkin, Evgeniy A; Takahashi, Shunji; Ramone, Daniella; Pikiel, Joanna; Maćkowiak-Matejczyk, Beata; Guerra Alía, Eva M; Colombo, Nicoletta; Makarova, Yulia; Rischin, Danny; Lheureux, Stephanie; Hasegawa, Kosei; Fujiwara, Keiichi; Li, Jingjin; Jamil, Shaheda; Jankovic, Vladimir; Chen, Chieh-I; Seebach, Frank; Weinreich, David M; Yancopoulos, George D; Lowy, Israel; Mathias, Melissa; Fury, Matthew G; Oaknin, Ana; and Investigators for GOG Protocol 3016 and ENGOT Protocol En-Cx9, "Survival with Cemiplimab in Recurrent Cervical Cancer." (2022). Articles, Abstracts, and Reports. 6290.