2026-04-13T02:51:17Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/121772024-11-09T02:41:50Zcom_2072_378070com_2072_378040col_2072_378092

2024-11-09T02:41:50Z urn:hdl:11351/12177 Cemiplimab monotherapy in Japanese patients with recurrent or metastatic cervical cancer Hasegawa, Kosei Takahashi, Shunji USHIJIMA, KIMIO Okadome, Masao Yonemori, Kan Yokota, Harushige OAKNIN, ANA 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 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. 2024-11-09T02:41:50Z 2024-11-09T02:41:50Z 2024-11-05T13:42:40Z 2024-11-05T13:42:40Z 2024-09-26 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://hdl.handle.net/11351/12177 Cancer Medicine;13(18) https://doi.org/10.1002/cam4.70236 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess Wiley Scientia