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

• DOI: 10.1038/s41467-024-45974-w
• Publication Date: 2024-03-05T08:02:22Z
• Authors: Gilles Freyer; Anne Floquet; Olivier Tredan; Aurore Carrot; Carole Langlois-J...; Jonathan Lopez; Frédéric Selle; Cyril Abdeddaim; Alexandra Leary; Coraline Dubot-Po...; Michel Fabbro; Laurence Gladieff; Michele Lamuraglia
• Keywords: Olaparib; Durvalumab

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