Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Randomised Phase III Trial Data on the Efficacy and Safety of Cemiplimab as Opposed to Chemotherapy in Patients with Progressive Advanced Cervical Cancer

ESMO Virtual Plenary

Session date: 12-13 May 2021

Abstract

VP4-2021: EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9: Interim analysis of phase III trial of cemiplimab vs. investigator’s choice (IC) chemotherapy (chemo) in recurrent/metastatic (R/M) cervical carcinoma

Authors

K.S. Tewari1, B.J. Monk2, I. Vergote3, A. Miller4, A.C. de Melo5, H.S. Kim6, Y.M. Kim6, A. Lisyanskaya7, V. Samouëlian8, D. Lorusso9, F. Damian10, C-L. Chang11, E.A. Gotovkin12, S. Takahashi13, D. Ramone14, J. Pikiel15, J. Li16, M. Mathias16, M.G. Fury16, A. Oaknin17 
Affiliations

DOI: 10.1016/j.annonc.2021.04.009

Background

Salvage chemo is ineffective for patients (pts) with R/M cervical cancer following progression on first-line (1L) platinum-based chemo + bevacizumab.

Methods

EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 is an open-label, randomised (1:1), multi-centre, phase III trial of anti-programmed cell death (PD)-1 cemiplimab vs. IC single agent chemo in R/M cervical cancer that has progressed after 1L platinum-based treatment (tx). Pts were enrolled regardless of PD-L1 expression; received cemiplimab 350 mg IV every 3 wks or IC chemo (pemetrexed, vinorelbine, gemcitabine, irinotecan or topotecan), up to 96 wks; and were stratified by histology (squamous cell carcinoma [SCC] / adenocarcinoma or adenosquamous [AC]). Primary endpoint was overall survival (OS), analysed hierarchically in pts with SCC followed by total population (SCC + AC). Additional endpoints included progression-free survival (PFS), objective response rate (ORR), quality of life (QoL) and safety. Interim analysis was scheduled when 85% events occurred among SCC pts.

Results

608 pts were randomised: median age, 51 years [range, 22‒87]; 477 SCC, 131 AC; ECOG performance score: 0 [46.5%], 1 [53.5%]. Median cemiplimab exposure was 15 wks (range, 1.4‒100.7). At interim analysis, OS (Table), PFS, ORR in overall and SCC populations, and mean change from baseline QoL in SCC, favoured cemiplimab. Most common tx emergent adverse events (AEs) of any grade for cemiplimab vs. IC chemo were anaemia (25% vs. 45%), nausea (18% vs. 33%) and vomiting (16% vs. 23%). Discontinuation due to AEs occurred in 8% (cemiplimab) and 5% (IC chemo).

Conclusions

Cemiplimab significantly improves OS over single agent chemo for pts with R/M cervical cancer after 1L platinum-based tx regardless of PD-L1 status or histology. No new safety signals were observed.

Clinical trial identification

NCT03257267.

Editorial acknowledgement

Writing support was provided by Randall Janairo, PhD, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc. and Sanofi.

Legal entity responsible for the study

Regeneron Pharmaceuticals, Inc., Sanofi, and GOG and ENGOT.

Funding

Regeneron Pharmaceuticals, Inc. and Sanofi.

Author affiliations

1Department of Obstetrics & Gynecology, University of California Irvine, Orange, CA, USA, 2Arizona Oncology (US Oncology Network) University of Arizona, Creighton University, Division of Gynecologic Oncology, Arizona, AZ, USA, 3Department of Obstetrics and Gynecology and Gynecologic Oncology, University Hospitals, Leuven, Belgium, 4Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA, 5Division of Clinical Research, Brazilian National Cancer Institute, Rio de Janeiro, Brazil, 6Department of Obstetrics and Gynecology, Seoul National University Hospital, Seoul, Republic of Korea, 7Department of Gynaecological Oncology, St. Petersburg State Budgetary Institution of Healthcare, St. Petersburg, Russian Federation, 8Gynecology Oncology, CHUM, CRCHUM, Université de Montréal, Montreal, QC, Canada, 9Gynaecology Oncology Unit, Fondazione Policlinico Universitario A Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy, 10Gynaecology, Hospital Sao Lucas PUCRS, Porto Alegre, Brazil, 11Gynaecology, MacKay Memorial Hospital, Taipei, Taiwan, 12Gynaecology, State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation, 13Department of Medical Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan, 14Clinical Research Department, Barretos Cancer Hospital (Pio XII Foundation), Barretos, Brazil, 15Gynaecology, Szpitale Pomorskie, Gdynia, Poland, 16Clinical Sciences Oncology, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA, 17Gynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain

Disclosures

K.S. Tewari: Financial Interests, Personal, Other, Honoraria: Tesaro, Clovis Oncology; Financial Interests, Personal, Advisory Role, Consulting or advisory roles: Genentech, Tesaro, Clovis, AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Genentech, AstraZeneca, Merck, Tesaro, Clovis; Financial Interests, Institutional, Research Grant: AbbVie, Genentech, Morphotek, Merck, Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Other, Travel, accommodations, expenses: Genentech.
B.J. Monk: Financial Interests, Personal, Other, Consulting honoraria: Aravive, Asymmetric Therapeutics, Boston Biomedical, ChemoCare, ChemoID, Circulogene, Conjupro Biotherapeutics, Eisai, Geistlich, Genmab/Seattle Genetics, Gynecologic Oncology Group Foundation, ImmunoGen, Immunomedics, Incyte, Laekna Health Care; Financial Interests, Personal, Other, Consulting honoraria: Mateon/Oxigene, Merck, Mersana, Myriad, Nucana, Oncomed, Oncoquest, Oncosec, Perthera, Pfizer, Precision Oncology, Puma, Regeneron, Samumed, Takeda, VBL, Vigeo; Financial Interests, Personal, Speaker’s Bureau, Consulting/speaker honoraria: AstraZeneca, Clovis, Janssen/Johnson & Johnson, Roche/Genentech, Tesaro/GSK.
I. Vergote: Financial Interests, Personal, Other, Consulting fees: AstraZeneca, Elevar Therapeutics, Genmab, GlaxoSmithKline, Immunogen, Merck Sharp & Dohme, Oncoinvent; Financial Interests, Personal, Research Grant: Genmab, F. Hoffmann-La Roche.
A.C. de Melo: Financial Interests, Personal, Advisory Board: MSD, BMS, Libbs; Financial Interests, Personal, Other, Support for travel or accommodation: AstraZeneca, MSD, BMS,d Roche; Financial Interests, Institutional, Research Grant: Clovis Oncology, BMS, Roche, Novartis, Amgen, MSD, Lilly, Pierre Fabre, Sanofi, Pfizer.
Y.M. Kim: Financial Interests, Personal, Stocks/Shares: Johnson & Johnson, Genolution; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Research Grant: Regeneron Pharmaceuticals, Inc., Roche.
D. Lorusso: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Clovis Oncology, Genmab, Immunogen, Merck Serono, MSD, PharmaMar, Roche, GSK; Financial Interests, Institutional, Research Grant: Clovis Oncology, MSD, PharmaMar, Roche, GSK; Financial Interests, Personal, Expert Testimony: Clovis Oncology; Financial Interests, Personal, Principal Investigator: AstraZeneca, Clovis Oncology, Genmab, Immunogen, MSD, PharmaMar, Roche, GSK; Financial Interests, Personal, Other, Travel support: AstraZeneca, PharmaMar, Roche, GSK; Non-Financial Interests, Personal, Other, Nonfinancial member interests: European Network for Gynaecological Oncological Trial groups (ENGOT), European Society of Gynaecological Oncology (ESGO), European Society for Medical Oncology (ESMO), Gynecologic Cancer Intergroup (GCIG; Board of Directors); Non-Financial Interests, Personal, Other, Nonfinancial member interests: Italian Association of Medical Oncology (AIOM), Multicenter Italian Trials in Ovarian Cancer (MITO).
S. Takahashi: Financial Interests, Personal, Other, Honoraria: Daiichi Sankyo, Eisai, Bayer, Taiho Pharmaceutical, MSD, Novartis, Chugai Pharma, AstraZeneca, Bristol-Myers Squibb Japan, Ono Pharmaceutical, Nihonkayaku, Pfizer, Lilly Japan; Financial Interests, Personal, Advisory Role: Bayer; Financial Interests, Personal, Research Grant: Daiichi Sankyo, Sanofi, Eisai, Bayer, Taiho Pharmaceutical, MSD, Novartis, Chugai Pharma, AstraZeneca, Bristol-Myers Squibb, Lilly, Ono Pharmaceutical, PharmaMar, Pfizer/EMD Serono; Financial Interests, Personal, Other, Travel, accommodation, and expenses: Daiichi Sankyo, Novartis.
J. Li: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.
M. Mathias: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.
M.G. Fury: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.
A. Oaknin: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, PharmaMar, Clovis Oncology, Tesaro, Inmunogen, Genmab, Mersana Therapeutic, GSK, Deciphera Pharmaceuticals; Financial Interests, Personal, Other, Support for travel or accommodation: Roche, AstraZeneca, PharmaMar.
All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.