Cemiplimab in recurrent cervical cancer: Final analysis of overall survival in the phase III EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial
- Author(s)
- Oaknin, A; Monk, BJ; de Melo, AC; Kim, HS; Kim, YM; Lisyanskaya, AS; Samouëlian, V; Lorusso, D; Damian, F; Chang, CL; Gotovkin, E; Takahashi, S; Ramone, D; Maćkowiak-Matejczyk, B; Polastro, L; Alia, EMG; Colombo, N; Makarova, Y; Goh, JC; Hasegawa, K; Mora, P; Pikiel, J; Srivastav, R; Rischin, D; Rubio, MJ; Perez, J; Yoo, SY; Gao, B; Jamil, S; Seebach, F; Lowy, I; Mathias, M; Fury, MG; Tewari, KS;
- Journal Title
- European Journal of Cancer
- Publication Type
- Research article
- Abstract
- AIM: Cemiplimab has demonstrated significantly longer survival than physician's choice of chemotherapy in patients with recurrent cervical cancer after first-line platinum-containing chemotherapy. We report the final survival analysis from the phase III randomized study (EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9). METHODS: Cemiplimab (n = 304) or chemotherapy (n = 304) were administered every 3 weeks. The primary endpoint was overall survival (OS). Patients were included regardless of programmed cell death-ligand 1 (PD-L1) status. RESULTS: At a median follow-up of 47.3 months (data cut-off: April 20, 2023), median OS was 11.7 versus 8.5 months for patients treated with cemiplimab and chemotherapy, respectively (hazard ratio 0.67, 95 % confidence interval 0.56-0.80, p < .00001). OS benefit was seen in PD-L1 positive and negative populations, even though more patients with PD-L1 < 1 % (n = 92), had poor performance status in the cemiplimab arm than the chemotherapy arm (61.4 % vs 47.9 %). CONCLUSION: This final analysis confirms that cemiplimab maintains survival benefit compared with chemotherapy in recurrent cervical cancer after progression on first-line platinum therapy, regardless of PD-L1 expression. The safety profile was consistent with published data; incidences of adverse events were similar between cemiplimab and chemotherapy groups. These results support the use of second-line cemiplimab for patients with recurrent cervical cancer.
- Publisher
- Elsevier
- Keywords
- Cemiplimab; Cervical cancer; Immunotherapy; Pd-1
- Department(s)
- Medical Oncology
- Publisher's Version
- https://doi.org/10.1016/j.ejca.2024.115146
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2025-04-08 07:34:53
Last Modified: 2025-04-08 07:35:28