519MO - Phase III EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial of cemiplimab in recurrent or metastatic (R/M) cervical cancer: Long-term survival analysis

Background

Interim overall survival (OS) analysis from the Phase 3 EMPOWER-Cervical 1 study showed that cemiplimab monotherapy significantly improved OS vs investigator’s choice (IC) single-agent chemotherapy (chemo) in patients (pts) with R/M cervical cancer after progression on first-line (1L) platinum-based chemo (median follow-up: 18.2 months). Cemiplimab had an acceptable safety profile, with Grade ≥3 adverse events occurring in 45.0% of cemiplimab-treated pts vs 53.4% of chemo-treated pts. We report the final survival analysis after a further 1-year of follow-up.

Methods

608 pts enrolled regardless of programmed cell death ligand 1 (PD-L1) status were randomised (1:1) to cemiplimab 350 mg IV Q3W or IC single-agent chemo for up to 96 weeks. Randomisation was stratified by histology (squamous cell carcinoma [SCC] or adenocarcinoma including adenosquamous carcinoma [AC]), ECOG performance status score, prior bevacizumab use, and geographic region. Primary endpoint was OS, analysed hierarchically in pts with SCC followed by overall population. Exploratory analyses of OS in pts with AC and OS by PD-L1 expression were performed. In this analysis, 371 (61.0%) pts had tumor samples evaluable for PD-L1 expression vs 254 (41.8%) pts in the prior analysis. We report OS for both PD-L1 populations. Data cutoff is Jan 4, 2022.

Results

Median (range) duration of follow-up was 30.2 (18.0–50.2) months. Cemiplimab significantly improved OS vs chemo, lowering risk of death by 31% and 34% in SCC and overall populations, respectively (Table). In the AC population, cemiplimab increased OS vs chemo with 45% lower risk of death. In the n=254 and n=371 PD-L1 populations, those with PD-L1 ≥1% and PD-L1 <1% had longer OS vs chemo. Table: 519MO

*Analysis of OS in the AC population and PD-L1 population subsets were exploratory with no adjustments for multiplicity.

Conclusions

With long-term follow-up, cemiplimab continues to show, in the overall population, a statistically significant and clinically meaningful improvement in OS vs chemo in pts with R/M cervical cancer after 1L platinum-based chemo.

Clinical trial identification

NIH: NCT03257267 EudraCT: 2017-000350-19.

Editorial acknowledgement

Medical writing support was provided by Atif Riaz, PhD, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc. and Sanofi.

Legal entity responsible for the study

Regeneron Pharmaceuticals Inc. and Sanofi.

Funding

Regeneron Pharmaceuticals Inc. and Sanofi.

Disclosure

A. Oaknin: Financial Interests, Personal, Advisory Board: Roche, PharmaMar, Clovis Oncology, Tesaro Inc., ImmunoGen, Genmab, Mersana Therapeutics, GlaxoSmithKline, Deciphera Pharmaceuticals, AstraZeneca; Financial Interests, Personal, Other, Support for travel or accommodation: Roche, AstraZeneca, PharmaMar. B.J. Monk: Financial Interests, Personal, Other, Consulting honoraria: Aravive, Inc., Asymmetric Therapeutics, Boston Biomedical, Inc., ChemoCare, ChemoID, Circulogene, Conjupro Biotherapeutics, Inc., Eisai, Geistlich, Genmab/Seattle Genetics, Gynecologic Oncology Group Foundation, ImmunoGen, Immunomedics, Incyte, Laekna Health Care, Mateon/Oxigene, Merck, Mersana Therapeutics, Myriad, NuCana, OncoMed Pharmaceuticals, Inc., OncoQuest Inc., OncoSec, Perthera, Pfizer, Precision Oncology, Puma Biotechnology, Regeneron Pharmaceuticals, Inc., Samumed, Takeda, VBL Therapeutics , Vigeo Therapeutics; Financial Interests, Personal, Speaker’s Bureau, Consulting/speaker honoraria: AstraZeneca, Clovis Oncology, Janssen/Johnson & Johnson, Roche/Genentech, Tesaro/GSK. A. Cristina de Melo: Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme Corp., Bristol-Myers Squibb, Libbs Farmaceutica; Financial Interests, Institutional, Research Grant: Clovis Oncology, Bristol-Myers Squibb, Roche, Novartis, Amgen, Merck Sharp & Dohme Corp. , Lilly, Pierre Fabre, Sanofi, Pfizer; Financial Interests, Personal, Other, Support for travel or accommodation: AstraZeneca, Merck Sharp & Dohme Corp. , Bristol-Myers Squibb, Roche. Y.M. Kim: Financial Interests, Personal, Other, Consulting honoraria: Merck Sharp & Dohme Corp; Financial Interests, Institutional, Research Grant: Regeneron Pharmaceuticals, Inc. , Roche; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson, Genolution. V. Samouëlian: Financial Interests, Personal, Advisory Board: Merck, GlaxoSmithKline; Financial Interests, Personal, Other, Consultancy role: Merck, GlaxoSmithKline. D. Lorusso: Financial Interests, Personal, Other, Consultancy fees: Amgen, PharmaMar; Financial Interests, Personal, Advisory Board: AstraZeneca, Clovis Oncology, GlaxoSmithKline, Merck, Sharp & Dohme; Financial Interests, Institutional, Research Grant: Clovis Oncology, Genmab, GlaxoSmithKline, Merck, Sharp & Dohme; Non-Financial Interests, Personal, Other, Member of the Board of Directors: Gynecologic Cancer InterGroup. S. Takahashi: Financial Interests, Personal, Other, Consulting honoraria: Daiichi Sankyo, Eisai, Bayer, Taiho Pharmaceutical, Merck Sharp & Dohme, Novartis, Chugai Pharma, AstraZeneca, Bristol-Myers Squibb Japan, Ono Pharmaceutical, Nihonkayaku , Pfizer , Eli Lilly Japan; Financial Interests, Institutional, Research Grant: Daiichi Sankyo, Sanofi, Eisai, Bayer, Taiho Pharmaceutical, Merck Sharp & Dohme, Novartis, Chugai Pharma, AstraZeneca, Bristol-Myers Squibb, Eli Lilly Japan, Ono Pharmaceutical, PharmaMar, Pfizer/EMD Serono; Financial Interests, Personal, Other, Support for travel and accommodation: Daiichi Sankyo, Novartis. B. Maćkowiak-Matejczyk: Financial Interests, Personal, Other, Honoraria: Roche, GlaxoSmithKline, AstraZeneca; Financial Interests, Personal, Advisory Board: Seagen Inc., GlaxoSmithKline; Financial Interests, Institutional, Research Grant: Seagen Inc., Mersana Therapeutics, Merck Sharp & Dohme Polska Sp.zo.o., AstraZeneca AB, AstraZeneca Pharma Poland Sp. z o.o., Parexel International Limited , Tesaro Bio Netherlands BV, Tesaro, Inc., Clovis Oncology, Seagen Inc., Quiniles Eastern Holdings, Regeneron Pharmaceuticals, Inc. J. Li: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. S. Jamil: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. M.D. 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, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc. K.S. Tewari: Financial Interests, Personal, Other, Honoraria: Tesaro Inc., Clovis Oncology; Financial Interests, Personal, Other, Consulting fees: Genentech, Tesaro Inc., Clovis Oncology, AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Genentech, AstraZeneca, Merck, Tesaro Inc., Clovis Oncology; Financial Interests, Institutional, Research Grant: AbbVie, Genentech, Morphotek, Merck, Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Other, Support for travel and accommodation: Genentech. All other authors have declared no conflicts of interest.