Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial - Archive ouverte HAL
Article Dans Une Revue Journal of Clinical Oncology Année : 2023

Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial

Jean-Emmanuel Kurtz
Eric Pujade-Lauraine
Ana Oaknin
Lisa Belin
  • Fonction : Auteur
Katharina Leitner
David Cibula
Hannelore Denys
Ora Rosengarten
  • Fonction : Auteur
Manuel Rodrigues
Nikolaus de Gregorio
  • Fonction : Auteur
Jeronimo Martinez García
Edgar Petru
  • Fonction : Auteur
Roman Kocián
Ignace Vergote
Patricia Pautier
  • Fonction : Auteur
Barbara Schmalfeldt
  • Fonction : Auteur
Lydia Gaba
Stephan Polterauer
Jalid Sehouli
  • Fonction : Auteur
Cristina Churruca
  • Fonction : Auteur
Frédéric Selle
  • Fonction : Auteur
Florence Joly
Véronique d'Hondt
Émilie Bultot-Boissier
  • Fonction : Auteur
Coriolan Lebreton
Jean-Pierre Lotz
Rémy Largillier
  • Fonction : Auteur
Pierre-Etienne Heudel
Florian Heitz

Résumé

PURPOSE Platinum-based doublets with concurrent and maintenance bevacizumab are standard therapy for ovarian cancer (OC) relapsing after a platinum-free interval (PFI) >6 months. Immunotherapy may be synergistic with bevacizumab and chemotherapy. PATIENTS AND METHODS ATALANTE/ENGOT-ov29 (ClinicalTrials.gov identifier: NCT02891824 ), a placebo-controlled double-blinded randomized phase III trial, enrolled patients with recurrent epithelial OC, one to two previous chemotherapy lines, and PFI >6 months. Eligible patients were randomly assigned 2:1 to atezolizumab (1,200 mg once every 3 weeks or equivalent) or placebo for up to 24 months, combined with bevacizumab and six cycles of chemotherapy doublet, stratified by PFI, PD-L1 status, and chemotherapy regimen. Coprimary end points were investigator-assessed progression-free survival (PFS) in the intention-to-treat (ITT) and PD-L1–positive populations (alpha .025 for each population). RESULTS Between September 2016 and October 2019, 614 patients were randomly assigned: 410 to atezolizumab and 204 to placebo. Only 38% had PD-L1–positive tumors. After 3 years' median follow-up, the PFS difference between atezolizumab and placebo did not reach statistical significance in the ITT (hazard ratio [HR], 0.83; 95% CI, 0.69 to 0.99; P = .041; median 13.5 v 11.3 months, respectively) or PD-L1–positive (HR, 0.86; 95% CI, 0.63 to 1.16; P = .30; median 15.2 v 13.1 months, respectively) populations. The immature overall survival (OS) HR was 0.81 (95% CI, 0.65 to 1.01; median 35.5 v 30.6 months with atezolizumab v placebo, respectively). Global health-related quality of life did not differ between treatment arms. Grade ≥3 adverse events (AEs) occurred in 88% of atezolizumab-treated and 87% of placebo-treated patients; grade ≥3 AEs typical of immunotherapy were more common with atezolizumab (13% v 8%, respectively). CONCLUSION ATALANTE/ENGOT-ov29 did not meet its coprimary PFS objectives in the ITT or PD-L1–positive populations. OS follow-up continues. Further research on biopsy samples is warranted to decipher the immunologic landscape of late-relapsing OC.

Domaines

Cancer

Dates et versions

hal-04205951 , version 1 (13-09-2023)

Identifiants

Citer

Jean-Emmanuel Kurtz, Eric Pujade-Lauraine, Ana Oaknin, Lisa Belin, Katharina Leitner, et al.. Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial. Journal of Clinical Oncology, In press, ⟨10.1200/JCO.23.00529⟩. ⟨hal-04205951⟩
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