2026-04-17T02:02:36Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/121772024-11-09T02:41:50Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Hasegawa, Kosei
author
Takahashi, Shunji
author
USHIJIMA, KIMIO
author
Okadome, Masao
author
Yonemori, Kan
author
Yokota, Harushige
author
OAKNIN, ANA
2024-11-09T02:41:50Z
2024-11-09T02:41:50Z
2024-11-05T13:42:40Z2024-11-05T13:42:40Z2024-09-26
http://hdl.handle.net/11351/12177
Cervical cancer; Immunotherapy; Programmed cell death‐1Càncer de coll uterí; Immunoteràpia; Mort cel·lular programada-1Cáncer de cuello uterino; Inmunoterapia; Muerte celular programada‐1Background
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.
Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
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
Cemiplimab monotherapy in Japanese patients with recurrent or metastatic cervical cancer
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion