712MO - Final overall survival (OS) from the phase III ATALANTE/ENGOT-ov29 trial evaluating atezolizumab (Atz) versus placebo with standard chemotherapy (Cx) plus bevacizumab (bev) in ovarian cancer (OC) patients (pts) with platinum-sensitive relapse (PSR)

Background

In the ATALANTE trial, adding Atz to standard therapy for PSR pts modestly increased median PFS in the ITT (13.5 vs 11.2 months [m]); HR 0.83, 95% CI, 0.69-0.99) and PD-L1-positive pts (15.2 vs 13.1 m; HR 0.86, 95% CI, 0.63 to 1.16), without reaching statistical significance. We report the exploratory final OS analysis at 5 years.

Methods

PSR OC pts were randomised 2:1 to Atz (1200 mg, d1, q3w or 800 mg, d1&15, q4w or placebo (Pbo) with carboplatin and PLD, gemcitabine or paclitaxel at investigator-choice (6 cycles) plus bev (15 mg/kg, d1, q3w or 10 mg/kg, d1&15, q4w), followed by Atz/Pbo plus bev maintenance for up to 24 months. OS analysis required at least 60% data maturity and it was performed two years after the primary endpoint completion date.

Results

614 pts were randomized to Atz (n=410) or Pbo (n=204). Median follow-up and OS data maturity were 60.1 m and 72.8%. In the ITT population, the median OS in the Atz and Pbo arms were 35.8 m (95% CI, 32.9-41.0) and 30.6 m (95% CI, 27.8-33.2) (HR, 0.79; 95% CI, 0.65 to 0.96) respectively. The 5-year OS rate favoured Atz: 27% (95% CI, 23-32) vs Pbo: 17% (95% CI, 12-23). In the PD-L1 positive population (>1% IC;38% of pts in both arms) the median OS in Atz and Pbo arms respectively were 43.0 m (95% CI, 38.1-50.2) vs 33.7 m (95% CI, 30.6-50.8) (HR, 0.84; 95% CI, 0.60 to 1.17) in Pbo. The 5-year OS rates were: Atz: 36% (95% CI, 29-45): 28% (95% CI, 19-42). There was no significant difference between both arms regarding the percentage of patients receiving first subsequent therapy (83.0 vs 86.8%) with Cx (74.4 vs 74.5%) including platinum (52.2 vs 52.9%), and/or PARP inhibitor (23.9 vs 22.1%), and/or bev (3.4 vs 3.4%) and/or immunotherapy (0 vs 1.9%).

Conclusions

In this exploratory analysis of the ATALANTE trial, with a 5-year follow-up, the median OS was prolonged by 5+ months in PSR OC pts when Atz is added to standard therapy. First subsequent therapy was similar in both arms. PD-L1 status was not predictive of Atz efficacy. More research is needed to better identify patients who benefit from this extended survival.

Clinical trial identification

EudraCT 2015-005471-24; NCT02891824 (last update 14 December 2023).

Editorial acknowledgement

Legal entity responsible for the study

ARCAGY-GINECO.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

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. E. Pujade-Lauraine: Financial Interests, Personal, Advisory Board, Speaker, Writing engagements: AZ, GSK; Financial Interests, Personal, Advisory Board, Speaker: Roche; Financial Interests, Personal, Other, IDMC: Incyte; Financial Interests, Personal, Full or part-time Employment: Arcagy. 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. C. Grimm: Financial Interests, Personal, Speaker, Consultant, Advisor: AZ, Eisai, GSK, MSD, Roche. H. Denys: Financial Interests, Institutional, Advisory Board: Pfizer, Seagen, Eli Lilly, roche, MSD, GSK; Financial Interests, Institutional, Invited Speaker: Roche, GSK, AstraZeneca, MSD, Pfizer, Amgen, Novartis; Financial Interests, Institutional, Research Grant: Gilead; Other, travel/accommodations/meeting subscription fee support for meeting organisation (institutional): Pfizer; Other, Travel/accommodations/meeting subscription fee support for meeting organisation (institutional): PharmaMar, Roche, Teva, GSK, AstraZeneca; Other, Travel/accommodations/meeting subscription support for meeting organisation (institutional): MSD; Other, travel/accommodations/ meeting subscription fee/support for meeting organisation: Gilead, Novartis. P. Follana: Financial Interests, Personal, Invited Speaker: GSK, Eisai, MSD; Financial Interests, Personal, Advisory Board: AZ, Novartis; Financial Interests, Personal, Other, Congress invitation: Gilead. J. Sehouli: Financial Interests, Personal, Advisory Board: Roche, GSK, AstraZeneca, MSD, Tesaro, ImmunoGen, Tubulis, Novocure, Incyte; Financial Interests, Personal, Invited Speaker: Eisei; Financial Interests, Institutional, Funding: Roche, GSK, AstraZeneca; Financial Interests, Institutional, Coordinating PI: Novocure; Non-Financial Interests, Institutional, Proprietary Information: ENGOT/NOGGO; Non-Financial Interests, Leadership Role, Council Member: ESGO; Non-Financial Interests, Leadership Role: North-Eastern German Society of Gynecological Oncology (NOGGO), Arbeitsgemeinschaft für Gynäkologische Onkologie (AGO), Pab-Arabian Research Society of Gynecological Oncology (PARSGO). 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. J. Alexandre: Financial Interests, Personal, Advisory Board: Eisai, MSD, GSK, Janssen, Pfizer, Seagen; Financial Interests, Personal, Invited Speaker: Eisai, MSD, AstraZeneca, GSK, Novartis; Financial Interests, Institutional, Research Grant: Janssen, GSK, MSD; Financial Interests, Institutional, Local PI: MSD, Eisai, Agenus, GSK, ImmunoGen, Incyte; Financial Interests, Institutional, Coordinating PI: Kartos. A. Hardy-Bessard: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Daiichi, Eisai, Novartis, Pfizer, Seagen; Non-Financial Interests, Principal Investigator: GSK. J. Frenel: Financial Interests, Personal, Advisory Board: Pfizer, Novocure, Pierre Fabre, Eisai Seagen, Gilead; Financial Interests, Personal, Invited Speaker: GSK, Amgen, Eisai; Financial Interests, Institutional, Advisory Board: Exactscience, Lilly, Daiichi Sankyo, AstraZeneca, Clovis Oncology; Financial Interests, Institutional, Invited Speaker: Novartis, MSD; Financial Interests, Coordinating PI: AstraZeneca, Seagen; Financial Interests, Local PI: MSD, Daiichi; Non-Financial Interests, Principal Investigator: Novartis, Lilly, AstraZeneca, Pfizer, Daiichi, MSD. R. Sabatier: Financial Interests, Personal, Other, Consulting: GSK, MSD; Financial Interests, Personal, Invited Speaker: Eisai, Clovis Oncology, GSK; Financial Interests, Personal, Advisory Board: Seagen Oncology; Financial Interests, Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Other, Travel fees: MSD, Novartis; Non-Financial Interests, Other, Congress fees: GSK. 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. T.-De La Motte Rouge: Financial Interests, Personal, Advisory Board: Pfizer, AstraZeneca, GSK, Clovis Oncology, Roche, MSD, Mylan, Tesaro, Gilead, Sanofi, Seagen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Institutional, Research Grant: Novartis, Pfizer, MSD, Seagen; Financial Interests, Institutional, Local PI: Roche, AstraZeneca, GSK, MSD, Pfizer, Netris Pharma; Financial Interests, Personal, Steering Committee Member: MSD; Non-Financial Interests, Advisory Role: French National Cancer Institute, Unicancer; Non-Financial Interests, Principal Investigator: Arcagy, Unicancer; Non-Financial Interests, Other, Co-Principal Investigator: Unicancer; Non-Financial Interests, Other, partnership using a Natera solution for a clinical trial funded by academic grant: Natera. E. Kalbacher: Financial Interests, Personal, Speaker, Consultant, Advisor: GSK, Seagen, MSD, AZ, Eisai, Daiichi, Roche, Leo Pharma, PharmaMar. F. Heitz: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, GSK, NovoCure; Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK. All other authors have declared no conflicts of interest.