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

2023; Lippincott Williams & Wilkins; Volume: 41; Issue: 30 Linguagem: Inglês

10.1200/jco.23.00529

1527-7755

Jean‐Emmanuel Kurtz, Éric Pujade-Lauraine, Ana Oaknin, Lisa Belin, Katharina Leitner, David Cibula, Hannelore Denys, Ora Rosengarten, Manuel Rodrigues, Nikolaus de Gregorio, Jerónimo Martínez, Edgar Petru, Roman Kocián, Ignace Vergote, Patricia Pautier, Barbara Schmalfeldt, Lydia Gaba, Stephan Polterauer, Marie‐Ange Mouret‐Reynier, Jalid Sehouli, Cristina Churruca, Frédèric Selle, Florence Joly, Véronique D’Hondt, Émilie Bultot-Boissier, Coriolan Lebreton, Jean‐Pierre Lotz, Rémy Largillier, Pierre-Étienne Heudel, Florian Heitz, Jean‐Emmanuel Kurtz, Sophie Abadie‐Lacourtoisie, Cyril Abdeddaim, J. Alexandre, P. Augereau, D. Avenin, M. Azémar, Nabil Baba-Hamed, Olivia Bally, Jérôme Barrière, Fernando Bazán, Dominique Berton, Nathalie Bonichon-Lamichhane, Nathalie Bonnin, Elouen Boughalem, R. Boustany Grenier, Pierre-Emmanuel Brachet, Fabien Brocard, Émilie Bultot-Boissier, Maria Cappiello-Bataller, Hélène Castanie, L. Chaigneau, Camille Chakiba, Dorothée Chocteau-Bouju, Pierre Combe, Aurélie Comte, Elodie Coquan, Cristina Costan, P. Cottu, L. Crouzet, H. Curé, Jérôme Dauba, Hussain Dawood, Laure De Cock, T. De La Motte Rouge, C. Debelleix, Catherine Delbaldo, Martin Demarchi, Marion Deslandres, Raymond Despax, Véronique D’Hondt, Anne Françoise DILLIES-LEGRAIN, A Donnadieu, C. Dubot, Jean Marc Extra, Michel Fabbro, Claire Falandry, F. Fiteni, Anne Floquet, Philippe Follana, Jean‐Sébastien Frenel, G. Freyer, D. Garbay-Decoopman, Céline Gavoille, V. Girre, Laurence Gladieff, F. Goldwasser, Alain Gratet, Jean‐Christophe Grenier, Anne‐Claire Hardy‐Bessard, Pierre-Étienne Heudel, Florence Joly, A. Jouinot, Emilie Kalbacher, Marie‐Christine Kaminsky, Laurence Lancry-Lecomte, R. Largillier, Fanny Le Du, Alexandra Léary, Coriolan Lebreton, C. Lefeuvre-Plesse, Anne Lesoin, T. L'Haridon, Jérôme Long, Alain Lortholary, Jean‐Pierre Lotz, Luigi Mansi, J. Martin-Babau, Mathilde Martinez, J. Medioni, Émeline Meriaux, Juliette Meunier, Laura Moise, J.-F. Moulin, Marie‐Ange Mouret‐Reynier, M. Mousseau, Patricia Pautier, J. Peron, Christophe Perrin, Thierry Petit, Daniela Petran, Frank Priou, Magali Provansal, Nadia Raban, Isabelle Ray‐Coquard, P. Régnault de la Mothe, Christopher C. Riedl, Manuel Rodrigues, C. Roemer-Bécuwe, R. Sabatier, Francesco Savinelli, Clara Sebbag, Frédèric Selle, P Soulié, D. Spaëth, Robert Sverdlin, M. Timar-David, Olivier Trédan, Patricia Tresca, V. Trillet-Lenoir, Thomas Valentin, Yann Vano, Benoît You, Florian Heitz, Holger Bronger, Paul Buderath, Nikolaus de Gregorio, Tanja Fehm, Eva‐Maria Grischke, M. Gropp-Meier, A. Hartkopf, C. Jackisch, Matthias Koegel, Andreas Mueller, Tjoung‐Won Park‐Simon, Ingo B. Runnebaum, Fabienne Schochter, Barbara Schmalfeldt, Benjamin Schnappauf, Jalid Sehouli, Fabian Trillsch, Pauline Wimberger, Ana Oaknin, Jesús Alarcón, Sonsoles Alonso, Ana Herrero, Maria-Pilar Barretina-Ginesta, Antonio Casado, Cristina Churruca, Iria Fernández, Lydia Gaba, Jesús García-Donás, Sergio González, Gloria Marquina, Jerónimo Martínez-García, Andrés Redondo, Diego Vicente, Christian Marth, Stefanie Aust, Edgar Petru, Alexander Reinthaller, Christian Schauer, David Cibula, Ignace Vergote, Sevilay Altıntaş, Hannelore Denys, Els Van Nieuwenhuysen, Ora Rosengarten,

Lymphoma Diagnosis and Treatment

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.