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Clinical Trial
. 2025 Feb 5:216:115146.
doi: 10.1016/j.ejca.2024.115146. Epub 2025 Jan 10.

Cemiplimab in recurrent cervical cancer: Final analysis of overall survival in the phase III EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial

Ana Oaknin  1 , Bradley J Monk  2 , Andreia Cristina de Melo  3 , Hee Seung Kim  4 , Yong Man Kim  5 , Alla S Lisyanskaya  6 , Vanessa Samouëlian  7 , Domenica Lorusso  8 , Fernanda Damian  9 , Chih-Long Chang  10 , Evgeniy Gotovkin  11 , Shunji Takahashi  12 , Daniella Ramone  13 , Beata Maćkowiak-Matejczyk  14 , Laura Polastro  15 , Eva Maria Guerra Alia  16 , Nicoletta Colombo  17 , Yulia Makarova  18 , Jeffrey C Goh  19 , Kosei Hasegawa  20 , Paulo Mora  21 , Joanna Pikiel  22 , Ratnesh Srivastav  23 , Danny Rischin  24 , Maria Jesús Rubio  25 , Javier Perez  26 , Suk Young Yoo  26 , Bo Gao  26 , Shaheda Jamil  26 , Frank Seebach  26 , Israel Lowy  26 , Melissa Mathias  26 , Matthew G Fury  26 , Krishnansu S Tewari  27
Affiliations
Clinical Trial

Cemiplimab in recurrent cervical cancer: Final analysis of overall survival in the phase III EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial

Ana Oaknin et al. Eur J Cancer. .

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.

Keywords: Cemiplimab; Cervical cancer; Immunotherapy; PD-1.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ana Oaknin: Personal fees for advisory boards: AstraZeneca, Clovis Oncology, Deciphera, Genmab, GSK, Immunogen, Mersana Therapeutics, PharmaMar, MSD, Agenus, Sutro, Corcept Therapeutics, EMD Serono, Novocure, Shattuck Labs, iTeos, Eisai; travel and accommodation: AstraZeneca, PharmaMar, Roche; funding to institution: AbbVie Deutschland, Advaxis Inc., Aeterna Zentaris, Amgen, Aprea Therapeutics AB, Clovis Oncology Inc., Eisai Ltd, F. Hoffmann-La Roche Ltd, Regeneron Pharmaceuticals, Inc., ImmunoGen Inc, MSD de España SA, Takeda, PharmaMar SA, Tesaro Inc., Bristol Myers Squibb. Bradley J. Monk: Consulting fees: Acrivon, Adaptimune, Agenus, Akeso Bi, Amgen, Aravive, AstraZeneca, Bayer, Clovis Oncology, Eisai, Elevar, EMD Merck, Genmab/Seagen, GOG Foundation, Gradalis, Heng Rui, ImmunoGen, Karyopharm, Iovance, Laekna, Macrogenics, Merck, Mersana, Myriad, Novartis, Novocure, OncoC4, Panavance, Pieris, Pfizer, Puma, Regeneron Pharmaceuticals, Inc., Roche/Genentech, Sorrento, TESARO/GSK, US Oncology Research, VBL, Verastem, Zentalis; payment/honoraria: AstraZeneca, Eisai, Myriad Roche/Genentech, TESARO/GSK. Andreia Cristina de Melo: Funding to institution: Amgen, AstraZeneca, Bristol Myers Squibb, Clovis Oncology, GSK, MSD, Novartis, Regeneron Pharmaceuticals, Inc., Roche; personal fees for lectures, presentations, speaker bureaus, manuscript writing, or educational events, and personal fees for participation in a data safety monitoring board or advisory board: AstraZeneca, Bristol Myers Squibb, Daiichi, GSK, MSD, Novartis, Roche. Hee Seung Kim: Nothing to disclose. Yong Man Kim: Stock and other ownership interests: Genolution, Johnson & Johnson; research funding: Regeneron Pharmaceuticals, Inc., Roche. Alla S. Lisyanskaya: Nothing to disclose. Vanessa Samouëlian: Conferences: AstraZeneca, Eisai, GSK, Merck; advisory board: AstraZeneca, GSK, Merck. Domenica Lorusso: Funding: AstraZeneca, Clovis Oncology, Pharma&, Genmad, GSK, Immunogen, MSD, Pharmamar, Novartis, Seagen, Alkermes, Incyte, Roche, Corcept; consulting fees: AstraZeneca, Corcept, Clovis Oncology, Daiichi Sankyo, Genmad, GSK, Immunogen, MSD, Novartis, Oncoinvest, Novocure, Seagen, Sutro; honoraria: AstraZeneca, Corcept, Genmab, GSK, Immunogen, MSD, Seagen; advisory boards: AstraZeneca, Corcept, Clovis Oncology, Daiichi Sankyo, Genmab, GSK, Immunogen, MSD, Oncoinvest, Novocure, Seagen, Sutro. Fernanda Damian: Nothing to disclose. Chih-Long Chang: Payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing, or educational events: AstraZeneca and MSD. Evgeniy Gotovkin: advisory/consultancy honoraria: AstraZeneca-MSD, Clovis Oncology, GSK-Tesaro, PharmaMar, Roche; speaker bureau/expert testimony honoraria: AstraZeneca-MSD, PharmaMar, Roche, GSK-Tesaro, Clovis, Eisai; and travel/accommodation/expenses from Roche, GSK-Tesaro, Baxter. Shunji Takahashi: Honoraria for lectures, presentations, speaker bureaus, manuscript writing, or educational events: AstraZeneca, Bayer, Bristol Myers Squib, Chugai, Daichi−Sankyo, Eisai, MSD, Novartis, Ono Pharmaceutical, Taiho; institutional grants: AstraZeneca, Bayer, Bristol Myers Squib, Chugai, Daichi−Sankyo, Eisai, MSD, Novartis, Ono Pharmaceutical, Taiho; institutional grant/honoraria: Sanofi. Daniella Ramone: Medical Director at ICON plc. Beata Maćkowiak-Matejczyk: Honoraria for lectures: AstraZeneca, GSK; support for attending meetings and/or travel: AstraZeneca; advisory board roles: GSK, Seagen. Laura Polastro: Grant research: Eisai, GSK, Seagen, Pharmamar and Pfizer. Maria Jesús Rubio Pérez: Consulting or advisory role: AstraZeneca, Clovis, Eisai, GSK, MSD, PharmaMar, Roche; speaker bureau: AstraZeneca, Clovis, GSK, Roche, MSD, Pharmamar; travel/accommodation/expenses: AstraZeneca, MSD, PharmaMar, Roche. Eva Maria Guerra Alia: Advisory/consultancy honoraria: AstraZeneca-MSD, Clovis Oncology, GSK-Tesaro, PharmaMar, Roche; speaker bureau/expert testimony honoraria: AstraZeneca-MSD, PharmaMar, Roche, GSK-Tesaro, Clovis, Eisai; travel/accommodation/expenses: Roche, GSK-Tesaro, Baxter. Nicoletta Colombo: Consulting (personal) fees: AstraZeneca, Clovis Oncology, Eisai, GSK, ImmunoGen, Inc., Mersana, MSD Oncology, Novocure, Pieris, Pfizer, Roche/Genentech; personal fees, lectures, presentations, speaker bureaus, manuscript writing, or educational events: AstraZeneca, Clovis Oncology, Eisai, GSK, ImmunoGen, Inc., MSD Oncology, Novartis, Roche/Genentech; participation in a data safety monitoring board or advisory board: AstraZeneca, Clovis Oncology, Eisai, GSK, ImmunoGen, Inc., Mersana, MSD Oncology, Novocure, Roche/Genentech, Pfizer; immediate family member is an employee of Sarepta. Yulia Makarova: Nothing to disclose. Jeffrey C Goh: Consultant/advisory board member: MSD, AstraZeneca, BMS, GSK; speaker bureaus for: MSD, AstraZeneca, BMS, Ipsen, GSK, Janssen & Bayer; travel/accommodation expenses: Bayer. Kosei Hasegawa: Consulting or advisory role: Eisai, Merck KGaA, MSD, Sanofi, Takeda, Roche, Daiichi Sankyo, Genmab, GSK; honoraria: AstraZeneca, Chugai Pharma, Eisai, Genmab, MSD, Kyowa Kirin, Daiichi Sankyo, Sanofi, Takeda; research grants: Daiichi Sankyo, Eisai, MSD, Ono Pharmaceutical, Takeda; travel expenses: Regeneron Pharmaceuticals, Inc., Seagen. Paulo Mora: Payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing, or educational events: AstraZeneca, MSD; support for attending meetings and/or travel: AstraZeneca; participation in a data safety monitoring board or advisory board: Knight. Joanna Pikiel: Grants or contracts: Astra Zeneca, GSK, Labcorp Drug Development, MSD, Roche, Sichuan Kelun-Biotech Biopharmaceutical; payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing, or educational events: AstraZeneca, Elly Lily; support for attending meetings and/or travel: Elly Lily, Novartis. Ratnesh Srivastav: Nothing to disclose. Danny Rischin: Institutional research grant and funding: ALX Oncology, Bristol-Myers Squibb, GlaxoSmithKline, Kura Oncology, Merck Sharp & Dohme, Regeneron Pharmaceuticals, Inc., Roche, Sanofi; uncompensated scientific committee and advisory board roles: Eisai, Bicara, GlaxoSmithKline, Merck Sharp & Dohme, Regeneron Pharmaceuticals, Inc., Sanofi. Javier Perez, Suk Young Yoo, Bo Gao, Shaheda Jamil, Frank Seebach, Israel Lowy, Melissa Mathias, and Matthew G. Fury: employees and stockholders of Regeneron Pharmaceuticals, Inc. Krishnansu S. Tewari: financial relationships: AbbVie, AstraZeneca, Eisai, GSK, ImmunoGen, Karyopharm, Merck, Morphotek, Regeneron Pharmaceuticals, Inc., Roche/Genentech, Seagen/Genmab.

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