722P - Long-term patient-reported outcomes (PROs) with atezolizumab (atezo) + bevacizumab (bev) and chemotherapy (CT) for metastatic, persistent or recurrent cervical cancer (R/M CC): BEATcc (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030) randomised phase III trial

Background

In the open-label randomised phase 3 BEATcc trial (NCT03556839), adding atezo to bev + CT for R/M CC significantly improved dual primary endpoints of progression-free and overall survival [Oaknin, Lancet 2024]. The impact of atezo on PROs in R/M CC is unknown.

Methods

Patients were randomised 1:1 to standard 1st-line therapy (bev, platinum, paclitaxel) ± atezo. Secondary objectives included evaluation of global health status/health-related quality of life (GHS/HRQoL) and functional (physical, role) scales of EORTC QLQ-C30; additional PRO objectives were exploratory. PROs were assessed using QLQ-C30, QLQ-CX24, FACT-G GP5 and EQ-5D-5L administered q9w for the 1st year and then q12w until 2nd progression/death or for up to 3 y. QLQ-C30 mean change from baseline (BL) was analysed by linear mixed-effect models up to wk 90. Deterioration was defined as a ≥10-point decrease (confirmed by a 2nd evaluation) or death to estimate time to deterioration (TTD).

Results

Of 410 randomised patients, 387 (94%) filled ≥1 PRO questionnaire, including >90% at BL (189 atezo, 185 standard arm). Across scales, BL scores were similar in the 2 treatment arms. At wk 90, mean change from BL GHS/HRQoL score was –8.3 vs –6.7 points in the atezo vs standard arms, respectively (difference –1.6; 95% CI –8.4 to 5.1). The TTD hazard ratio was 0.83 (95% CI 0.66–1.05; median 11.3 mo with atezo vs 10.3 mo with standard therapy). Similar patterns were observed for most function and symptom scales with no meaningful difference between treatment arms (table). In both arms, the most severe symptoms were fatigue, pain and insomnia, which showed no clinically relevant change from BL at wk 90. Table: 722P

Conclusions

Adding atezo to 1st-line bev + CT did not impair GHS/HRQoL. These results further support the role of atezo combined with standard therapy as a new 1st-line treatment option for R/M CC.

Clinical trial identification

NCT03556839; EudraCT 2018-000367-83; ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030/BEATcc.

Editorial acknowledgement

Jennifer Kelly (Medi-Kelsey Ltd).

Legal entity responsible for the study

GEICO.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

L. Gladieff: Financial Interests, Personal, Other, Congress funding: Viatris, Roche; Financial Interests, Institutional, Invited Speaker: MSD, Clovis, GSK, Eisai; Financial Interests, Institutional, Advisory Board: Clovis, GSK; Financial Interests, Personal, Invited Speaker: AstraZeneca. J. Martinez-Garcia: Financial Interests, Personal, Advisory Board: AstraZeneca, Clovis, GSK-Thesaro, PharmaMar; Financial Interests, Institutional, Research Grant: Roche, GSK; Other, Travel/accommodation/expenses for oncology meeting: PharmaMar, GSK-Thesaro, Pfizer. G. Villacampa: Financial Interests, Personal, Invited Speaker, Invited speaker in a course: MSD; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker, Invited speaker in an internal training: Pierre Fabre, GSK; Financial Interests, Personal, Invited Speaker, Internal discussion about the interpretation of some published results: Pfizer; Financial Interests, Personal, Other, Collaborations with specific projects: Reveal Genomics. U. De Giorgi: Financial Interests, Personal, Advisory Board: Pfizer, BMS, MSD, PharmaMar, Astellas, Bayer, Ipsen, Novartis, Eisai, Janssen; Financial Interests, Personal, Invited Speaker: Roche, BMS, AstraZeneca, Merck; Financial Interests, Institutional, Research Grant: AstraZeneca, Sanofi, Roche. P. Harter: Financial Interests, Personal, Advisory Board, Value includes honoraria for lectures: AstraZeneca; Financial Interests, Personal, Advisory Board, includes honoraria for lectures: GSK, Roche, MSD; Financial Interests, Personal, Invited Speaker: Amgen, Stryker, Zailab, Eisai, Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Clovis, ImmunoGen, Novartis, Mersana, Miltenyi, Exscientia; Financial Interests, Personal, Other, IDMC member: Sotio; Financial Interests, Institutional, Trial Chair: AstraZeneca, Roche, GSK, ImmunoGen; Financial Interests, Institutional, Local PI: Genmab; Financial Interests, Institutional, Funding: Seagen, Clovis; Financial Interests, Institutional, Other, Co-investigator: Novartis; Non-Financial Interests, Principal Investigator: AstraZeneca; Other, Travel support for conference: AstraZeneca. L. Duska: Financial Interests, Personal, Advisory Board, Scientific advisory board: Aadi Bioscience; Financial Interests, Personal, Royalties, I write expert content for UpToDate: UpToDate; Financial Interests, Personal, Other, I serve on the Editorial Board: British Journal of Obstetrics and Gynecology; Financial Interests, Institutional, Research Grant, Merck has provided funding for investigator initiated trials to my institution: Merck; Non-Financial Interests, Advisory Role, Acted as an expert advisor for: Merck. A. Godoy Ortiz: Financial Interests, Personal, Invited Speaker: Novartis, AstraZeneca; Non-Financial Interests, Principal Investigator, I'm PI in several clinical trials in breast and gynecological cancers: Novartis, AstraZeneca, Roche, GSK, Merck; Non-Financial Interests, Member: CIBERONC. C. Bellier: Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Institutional, Local PI: Roche. L. Fariñas Madrid: Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Institutional, Invited Speaker: AstraZeneca & MSD, Pharma&; Financial Interests, Personal, Invited Speaker: Eisai, GSK. J.D. Alarcon: Financial Interests, Institutional, Advisory Board: GSK, Clovis, AstraZeneca, MSD; Financial Interests, Institutional, Invited Speaker: Roche, GSK, Eisai; Other, educational grant for congress (ESMO): GSK; Other, grant for virtual congress SGO, ESGO: GSK. J.E. Kurtz: Financial Interests, Personal, Advisory Board, Participation to Advisory Boards: GSK; Financial Interests, Personal, Other, Travel Incentives: AstraZeneca; Financial Interests, Personal, Other, Travel incentives: GSK, Eisai; Financial Interests, Personal, Advisory Board, Advisory Board: Eisai, MSD; Other, Family member is an employee of MDS: MSD. L.M. Randall: Financial Interests, Personal, Other, Honoraria: Per, CurioScience; Financial Interests, Personal, Advisory Board, Consulting or Advisory Role: AstraZeneca, GOG Foundation, Merck, Mersana, Seagen, Eisai, Aadi Biosciences, ImmunoGen; Financial Interests, Personal, Invited Speaker, Speakers' Bureau: Genmab/Seagen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca, Seagen, Genmab, GOG Foundation; Financial Interests, Institutional, Funding: AstraZeneca, Merck, GEICO; Financial Interests, Institutional, Local PI: Karyopharm, ImmunoGen, Acrivon; Financial Interests, Institutional, Coordinating PI: Zentalis; Non-Financial Interests, Member of Board of Directors: GOG Foundation. A. Oaknin: Financial Interests, Personal, Advisory Board: Agenus, AstraZeneca, Clovis Oncology, Corcept Therapeutics, Deciphera Pharmaceuticals, Eisai, F. Hoffmann-La Roche, GSK, Genmab, ImmunoGen, Itheos, MSD, Mersana Therapeutics, Novocure, OncoXerna Therapeutics, Inc, PharmaMar, Regeneron, Shattuck Labs, Seagen/Pfizer, Sutro Biopharma, Exelisis, DaIichi Sankyo, Debiopharm International, Myriad Genetics, Zentalis; Financial Interests, Personal, Other, Travel and accommodation: AstraZeneca, PharmaMar, Roche; Financial Interests, Institutional, Funding: Amgen, AbbVie Deutschland, Advaxis Inc., Aeterna Zentaris, Aprea Therapeutics AB, Regeneron Pharmaceuticals, Clovis Oncology Inc, Eisai Limited Ltd, F. Hoffmann –La Roche LTD, ImmunoGen Inc, Merck, Sharp & Dohme de España SA, Millennium Pharmaceuticals Inc, PharmaMar SA, Tesaro Inc., Bristol Myers Squibb; Non-Financial Interests, Leadership Role, on behalf of GEICO: GCIG; Non-Financial Interests, Officer, Chair of Gynaecological Track ESMO 2019. Scientific Track Member Gynaecological Cancers ESMO 2018, ESMO 2020, ESMO 2022. Member of Gynaecological Cancers Faculty and Subject Editor Gyn ESMO Guidelines.: ESMO; Non-Financial Interests, Leadership Role, ESMO GYN Co-Chair 2023 - 2025: ESMO; Non-Financial Interests, Leadership Role, Chair de Cervix Committee. 2022-2024: GCIG; Non-Financial Interests, Member: ESMO, ASCO, GCIG, SEOM, GOG. All other authors have declared no conflicts of interest.