Abstract 783P
Background
Cemiplimab significantly improved overall survival in pts with R/M cervical cancer after first-line (1L) platinum-based chemotherapy (chemo) (NCT03257267; ESMO-VP-2021). We now report patient-reported QoL, functioning and symptoms from the trial.
Methods
Pts with R/M cervical cancer who progressed after 1L chemo were randomised (1:1) to cemiplimab 350 mg Q3W IV (N=304) or investigator’s choice chemo for up to 96 weeks (N=304). At baseline (BL) and Day 1 of each 6-week treatment cycle (up to 16), pts were administered the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. Mixed-effects repeated measures models estimated overall least squares (LS) mean change from BL for global health status (GHS)/QoL and physical functioning (PF); results reported for the squamous cell carcinoma (SCC) and the overall (SCC + adenocarcinoma [AC]) populations were formally defined per statistical hierarchy for multiplicity adjustment. Other analyses for QoL were not adjusted for multiplicity and nominal P-values were reported.
Results
BL scores showed moderate‒high functioning and low‒moderate symptom burden with minimal differences across groups. For SCC, cemiplimab generally maintained GHS/QoL (1.2 [95% CI, ‒2.0 to 4.3] vs ‒7.3 [95% CI, ‒11.5 to ‒3.1]; difference, 8.5; P=0.00025) and PF (LS mean change 1.0 [95% CI, ‒ 1.9 to 3.9] vs ‒7.3 [95% CI, ‒ 11.1 to ‒ 3.6]; difference, 8.4; P=0.00008) vs generally worsened with chemo. Findings were consistent in the overall population. Significant differences in LS mean changes favored cemiplimab for other functioning and key symptom scales (Table).
Conclusions
In pts with R/M cervical cancer, cemiplimab provided significant benefit vs chemo in GHS/QoL and physical functioning, along with other functioning and key symptom scales. Table: 783P
Overall difference between cemiplimab and chemo in LS mean change from BL (95% CI)a
| Overall* | SCC* | ACb | |
| Role functioning | 13.1 (8.3; 17.9) | 11.4 (6.3; 16.6) | 8.3 (–0.0; 16.6) |
| Emotional functioning | 7.2 (3.0; 11.4) | 5.3 (1.1; 9.4) | 11.2 (3.8; 18.6) |
| Social functioning | 7.6 (3.0; 12.3) | 6.1 (1.0; 11.2) | 9.3 (0.2; 18.4) |
| Fatigue | –9.1 (–14.1; –4.0) | –8.6 (–14.0; –3.3) | –5.9 (–13.9; 2.2) |
| Pain | –10.2 (–16.2; –4.3) | –10.4 (–16.9; –3.8) | –7.6 (–17.1; 1.9) |
| Appetite loss | –11.3 (–16.6; –6.0) | –10.9 (–16.6; –5.2) | –8.7 (–19.8; 2.4) |
*Two-sided nominal P<.05. aPositive numbers favour cemiplimab except for symptom scale, negative numbers favour cemiplimab. bFormal statistical test was not pre-specified.CI, confidence interval.
Clinical trial identification
NCT03257267.
Editorial acknowledgement
Medical writing support was provided by Imogen Francis, 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, AstraZeneca, PharmaMar, Clovis Oncology, Tesaro, Inmunogen, Genmab, Mersana Therapeutic, GSK and Deciphera Pharmaceuticals; Financial Interests, Personal, Other, Support for travel or accommodation: Roche, AstraZeneca, and PharmaMar. 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, and Vigeo; Financial Interests, Personal, Invited Speaker, Consulting/speaker honoraria: AstraZeneca, Clovis, Janssen/Johnson & Johnson, Roche/Genentech, and Tesaro/GSK. I. Vergote: Financial Interests, Personal, Other, Consulting fees : AstraZeneca, Elevar Therapeutics, Genmab, GlaxoSmithKline, Immunogen, Merck Sharp & Dohme and Oncoinvent; Financial Interests, Personal, Research Grant: Genmab and Hoffmann-La Roche. A.C. de Melo: Financial Interests, Personal, Advisory Board: MSD, BMS and Libbs; Financial Interests, Personal, Other, Support for travel or accommodation: AstraZeneca, MSD, BMS and Roche; Financial Interests, Institutional, Research Grant: Clovis Oncology, BMS, Roche, Novartis, Amgen, MSD, Lilly, Pierre Fabre, Sanofi and Pfizer. Y.M. Kim: Financial Interests, Personal, Stocks/Shares, For self and spouse: Johnson & Johnson and Genolution; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Research Grant: Regeneron Pharmaceuticals, Inc. and Roche. 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 and 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 and Pfizer/EMD Serono; Financial Interests, Personal, Other, Travel, accommodation, and expenses: Daiichi Sankyo and 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. C. Ivanescu: Financial Interests, Personal, Full or part-time Employment: IQVIA ; Financial Interests, Institutional, Research Grant: Regeneron Pharmaceuticals, Inc. M. Reaney: Financial Interests, Personal, Full or part-time Employment: IQVIA ; Financial Interests, Institutional, Research Grant: Regeneron Pharmaceuticals, Inc. J. Harnett: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. C. Chen: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. K.S. Tewari: Financial Interests, Personal, Other, Honoraria: Tesaro and Clovis Oncology; Financial Interests, Personal, Advisory Role: Genentech, Tesaro, Clovis and AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Genentech, AstraZeneca, Merck, Tesaro and Clovis; Financial Interests, Institutional, Research Grant: AbbVie, Genentech, Morphotek, Merck and Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Other, Travel, accommodations, expenses: Genentech. All other authors have declared no conflicts of interest.