Sistema de Salut de Catalunya
Institut Català de la Salut
[Hasegawa K] Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan. [Takahashi S] Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. [Ushijima K] Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Japan. [Okadome M] Gynecology Service, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan. [Yonemori K] Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. [Yokota H] Saitama Cancer Center, Saitama, Japan. [Oaknin A] Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2024-11-05T13:42:40Z
2024-11-05T13:42:40Z
2024-09-26
Cervical cancer; Immunotherapy; Programmed cell death‐1
Càncer de coll uterí; Immunoteràpia; Mort cel·lular programada-1
Cáncer de cuello uterino; Inmunoterapia; Muerte celular programada‐1
Background In the phase 3 EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 study, cemiplimab significantly improved overall survival (OS) versus chemotherapy for patients with recurrent or metastatic cervical cancer who progressed after first-line platinum-based chemotherapy. We present a post hoc subgroup analysis of patients enrolled in Japan. Methods Patients were enrolled regardless of programmed cell death-ligand 1 status and randomized 1:1 to cemiplimab 350 mg intravenously every 3 weeks or investigator's choice single-agent chemotherapy for up to 96 weeks. Primary endpoint was OS. Key secondary endpoints were progression-free survival (PFS) and objective response rate (ORR). Results Overall, 608 patients were randomized, of whom 56 (9.2%) were in Japan (cemiplimab, n = 29; chemotherapy, n = 27). The median (range) duration of follow-up was 13.6 (6.0–25.3) versus 18.2 (6.0–38.2) months for patients in Japan and for the overall population, respectively. Median OS (95% confidence interval [CI]) was 8.4 (7.0-not evaluable) and 9.4 (5.4–14.9) months for cemiplimab versus chemotherapy (hazard ratio [HR]: 0.86; 95% CI: 0.43–1.68). Median PFS (95% CI) was 4.0 (1.4–8.2) versus 3.7 (1.8–4.2) months with cemiplimab and chemotherapy (HR: 0.90; 95% CI: 0.50–1.61), respectively. ORR was 17.2% for cemiplimab and 7.4% for chemotherapy (odds ratio, 2.47; 95% CI, 0.44–13.99). Incidence of treatment-emergent adverse events at any grade was 79.3% for cemiplimab and 100% for chemotherapy. Grade ≥3 adverse events were 37.9% versus 66.7% with cemiplimab and chemotherapy, respectively. Discussion While acknowledging limitations inherent to a small subgroup analysis, the HR of 0.86 observed in Japanese patients suggests an emerging survival benefit despite a 4.6-month shorter median duration of follow-up versus the overall study population.
This study was funded by Regeneron Pharmaceuticals, Inc., and Sanofi.
Article
Published version
English
Coll uterí - Càncer - Immunoteràpia; Anticossos monoclonals - Ús terapèutic; Japonesos; DISEASES::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Female::Uterine Neoplasms::Uterine Cervical Neoplasms; Other subheadings::Other subheadings::Other subheadings::/drug therapy; CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized; Other subheadings::Other subheadings::/therapeutic use; GEOGRAPHICALS::Geographic Locations::Asia::Far East::Japan; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales femeninos::neoplasias uterinas::neoplasias del cuello uterino; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados; Otros calificadores::Otros calificadores::/uso terapéutico; DENOMINACIONES GEOGRÁFICAS::localizaciones geográficas::Asia::Extremo Oriente::Japón
Wiley
Cancer Medicine;13(18)
https://doi.org/10.1002/cam4.70236
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
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