Bevacizumab, olaparib, and durvalumab in patients with relapsed ovarian cancer: a phase II clinical trial from the GINECO group

Gilles Freyer (), Anne Floquet, Olivier Tredan, Aurore Carrot, Carole Langlois-Jacques, Jonathan Lopez, Frédéric Selle, Cyril Abdeddaim, Alexandra Leary, Coraline Dubot-Poitelon, Michel Fabbro, Laurence Gladieff and Michele Lamuraglia
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Gilles Freyer: Lyon 1 University
Anne Floquet: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire
Olivier Tredan: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire
Aurore Carrot: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire
Carole Langlois-Jacques: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire
Jonathan Lopez: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire
Frédéric Selle: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire
Cyril Abdeddaim: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire
Alexandra Leary: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire
Coraline Dubot-Poitelon: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire
Michel Fabbro: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire
Laurence Gladieff: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire
Michele Lamuraglia: GINECO (Groupe d’Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire

Nature Communications, 2024, vol. 15, issue 1, 1-11

Abstract: Abstract Most patients with advanced ovarian cancer (AOC) ultimately relapse after platinum-based chemotherapy. Combining bevacizumab, olaparib, and durvalumab likely drives synergistic activity. This open-label phase 2 study (NCT04015739) aimed to assess activity and safety of this triple combination in female patients with relapsed high-grade AOC following prior platinum-based therapy. Patients were treated with olaparib (300 mg orally, twice daily), the bevacizumab biosimilar FKB238 (15 mg/kg intravenously, once-every-3-weeks), and durvalumab (1.12 g intravenously, once-every-3-weeks) in nine French centers. The primary endpoint was the non-progression rate at 3 months for platinum-resistant relapse or 6 months for platinum-sensitive relapse per RECIST 1.1 and irRECIST. Secondary endpoints were CA-125 decline with CA-125 ELIMination rate constant K (KELIM-B) per CA-125 longitudinal kinetics over 100 days, progression free survival and overall survival, tumor response, and safety. Non-progression rates were 69.8% (90%CI 55.9%-80.0%) at 3 months for platinum-resistant relapse patients (N = 41), meeting the prespecified endpoint, and 43.8% (90%CI 29.0%-57.4%) at 6 months for platinum-sensitive relapse (N = 33), not meeting the prespecified endpoint. Median progression-free survival was 4.1 months (95%CI 3.5–5.9) and 4.9 months (95%CI 2.9–7.0) respectively. Favorable KELIM-B was associated with better survival. No toxic deaths or major safety signals were observed. Here we show that further investigation of this triple combination may be considered in AOC patients with platinum-resistant relapse.

Date: 2024
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DOI: 10.1038/s41467-024-45974-w

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