Evidence map›Paper›PMID 39325020›Full record

Trial reportCancer medicine2024

Cemiplimab monotherapy in Japanese patients with recurrent or metastatic cervical cancer.

Kosei Hasegawa, Shunji Takahashi, Kimio Ushijima, Masao Okadome, Kan Yonemori, Harushige Yokota, Ignace Vergote, Bradley J Monk, Krishnansu S Tewari, Keiichi Fujiwara and 15 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Trial
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  5. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Kosei HasegawaDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.ORCID https://orcid.org/0000-0002-1903-7001
Shunji TakahashiDepartment of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Kimio UshijimaDepartment of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Japan.
Masao OkadomeGynecology Service, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Kan YonemoriDepartment of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Harushige YokotaSaitama Cancer Center, Saitama, Japan.
Ignace VergoteDepartment of Gynecology and Obstetrics, University Hospitals, Katholieke Universiteit Leuven, Leuven, Belgium.
Bradley J MonkDivision of Gynecologic Oncology, University of Arizona and Creighton University, Phoenix, Arizona, USA.
Krishnansu S TewariDepartment of Gynecology and Obstetrics, University of California, Irvine, California, USA.
Keiichi FujiwaraDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.
Jingjin LiRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Shaheda JamilRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Anne PaccalyRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Kazuhiro TakeharaDepartment of Gynaecologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.ORCID https://orcid.org/0000-0001-8808-3338
Tomoka UsamiDepartment of Obstetrics and Gynaecology, Ehime University School of Medicine, Toon, Japan.
Yoichi Aoki *Department of Obstetrics and Gynaecology, University of the Ryukyus Hospital, Okinawa, Japan.
Nao SuzukiDepartment of Obstetrics and Gynaecology, St Marianna University School of Medicine, Kawasaki, Japan.
Yoichi KobayashiDepartment of Obstetrics and Gynaecology, Faculty of Medicine, Kyorin University, Tokyo, Japan.
Yoshio YoshidaDepartment of Obstetrics and Gynaecology, University of Fukui, Fukui, Japan.
Hidemichi WatariDepartment of Obstetrics and Gynaecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Frank SeebachRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Israel LowyRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Melissa MathiasRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Matthew G FuryRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Ana OakninGynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.

Funding

Regeneron PharmaceuticalsSanofi
6 · The paper itself

Abstract

backgroundIn 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.

methodsPatients 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).

resultsOverall, 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.

Indexed as

Antibodies, Monoclonal, HumanizedNeoplasm Recurrence, LocalUterine Cervical NeoplasmsAdultAgedAntineoplastic Agents, ImmunologicalEast Asian PeopleFemaleHumansJapanMiddle AgedProgression-Free SurvivalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalcemiplimabcemiplimabcervical cancerchemotherapyimmunotherapyprogrammed cell death‐1

Identifiers

PMID39325020
PMCPMC11426160

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.