EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer

Abstract

Background: In a phase III, randomised, active-controlled study (EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9; R2810-ONC-1676; NCT03257267) and cemiplimab significantly improved survival versus investigator's choice of chemotherapy among patients with recurrent cervical cancer who had progressed on platinum-based therapy. Here we report patient-reported outcomes in this pivotal study.

Methods: Patients were randomised 1:1 to open-label cemiplimab (350 mg intravenously every 3 weeks) or investigator's choice of chemotherapy in 6-week cycles. Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 during cycles 1-16. Least-squares mean changes from baseline in global health status (GHS)/quality of life (QoL) and physical functioning (PF) were secondary end-points in the statistical hierarchy.

Results: Of 608 patients (304/arm), 77.8% patients had squamous cell carcinoma and 22.2% patients had adenocarcinoma. Questionnaire completion rates were ∼90% throughout. In the squamous cell carcinoma population, overall between-group differences statistically significantly favoured cemiplimab in GHS/QoL (8.49; 95% confidence interval [CI]: 3.77-13.21; P = 0.0003) and PF (8.35; 95% CI: 4.08-12.62; P < 0.0001). Treatment differences favoured cemiplimab in both histologic populations by cycle 2. Overall changes from baseline in most functioning and symptom scales favoured cemiplimab, with clinically meaningful treatment differences in role functioning, appetite loss and pain in both populations. The sensitivity analyses, responder analyses and time to definitive deterioration favoured cemiplimab in both populations.

Conclusions: Cemiplimab conferred favourable differences in GHS/QoL and PF compared with chemotherapy among patients with recurrent cervical cancer, with benefits in PF by cycle 2, and clinically meaningful differences favouring cemiplimab in role functioning, appetite loss, and pain.

Keywords: Cemiplimab; Chemotherapy; Functioning; Patient-reported outcomes; Quality of life; Symptoms.

Conflict of interest statement

Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: A.O. reports serving on advisory boards for Roche, AstraZeneca, MSD/Merck, PharmaMar, Clovis Oncology, Tesaro, Immunogen, Genmab, Mersana Therapeutic, GSK, SUTRO, AGENUS and Deciphera Pharmaceuticals; and support for travel or accommodation from Roche, AstraZeneca and PharmaMar. B.J.M. reports consulting honoraria from 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, Mateon/Oxigene, Merck, Mersana, Myriad, Nucana, Oncomed, Oncoquest, Oncosec, Perthera, Pfizer, Precision Oncology, Puma, Regeneron, Samumed, Takeda, VBL and Vigeo; and consulting or speaker honoraria from AstraZeneca, Clovis, Janssen/Johnson & Johnson, Roche/Genentech and Tesaro/GSK. I.V. reports consulting fees from AstraZeneca, Elevar Therapeutics, Genmab, GSK, Immunogen, Merck Sharp & Dohme and Oncoinvent; and contracted research from Genmab and Hoffmann-La Roche. A.C.M. has served on advisory boards for Merck Sharp & Dohme, Bristol-Myers Squibb and Libbs; has received support for travel or accommodation from AstraZeneca, Merck Sharp & Dohme, Bristol-Myers Squibb and Roche; and reports institutional research grant support from Clovis Oncology, Bristol-Myers Squibb, Roche, Novartis, Amgen, Merck Sharp & Dohme, Lilly, Pierre Fabre, Sanofi and Pfizer. Y.M.K. reports ownership of stock at Johnson & Johnson and Genolution for self and spouse; consulting or advisory role at Merck Sharp & Dohme; and research funding from Regeneron Pharmaceuticals, Inc., and Roche. A.S.L., V.S., H.S.K., E.A.G., F.D. and C.-L.C. declare no conflict of interest. S.T. reports honoraria from Daiichi Sankyo, Eisai, Bayer, Taiho Pharmaceutical, Merck Sharp & Dohme, Novartis, Chugai Pharma, AstraZeneca, Bristol-Myers Squibb Japan, Ono Pharmaceutical, Nihonkayaku, Pfizer and Lilly Japan; advisory role at Bayer; research funding from Daiichi Sankyo, Sanofi, Eisai, Bayer, Taiho Pharmaceutical, Merck Sharp & Dohme, Novartis, Chugai Pharma, AstraZeneca, Bristol-Myers Squibb, Lilly, Ono Pharmaceutical, PharmaMar and Pfizer/EMD Serono; and travel, accommodation and expenses from Daiichi Sankyo and Novartis. J.L., M.M., M.G.F., I.L., J.H. and C.C. are employees and shareholders of Regeneron Pharmaceuticals, Inc. C.I. and M.R. report employment at IQVIA and institutional research funding from Regeneron Pharmaceuticals, Inc. P.R.L. is an employee of, and may hold shares and stock options in Sanofi. K.T. reports honoraria from Tesaro and Clovis Oncology; consulting or advisory roles for Genentech, Tesaro, Clovis and AstraZeneca; serving on a speaker's bureau for Genentech, AstraZeneca, Merck, Tesaro and Clovis; institutional research funding from AbbVie, Genentech, Morphotek, Merck and Regeneron Pharmaceuticals, Inc.; and travel, accommodation and expenses from Genentech.

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