Durvalumab with paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm): Results from the randomized, placebo (pbo)-controlled phase III DUO-O trial.

作者：Philipp Harter, Fabian Trillsch, Aikou Okamoto, Alexander Reuß, Jae‐Weon Kim, María Jesús Rubio-Pérez, Mehmet Ali Vardar, Giovanni Scambia, Olivier Trédan, Gitte‐Bettina Nyvang, Nicoletta Colombo, Anita Monika Chudecka-Glaz, Christoph Grimm, Stéphanie Lheureux, Els Van Nieuwenhuysen, Florian Heitz, Robert Michael Wenham, Kimio Ushijima, Emily Day, Carol A Aghajanian · 发表于：Journal of Clinical Oncology · 年份：2023 · DOI：10.1200/jco.2023.41.17_suppl.lba5506 · 被引用次数：55 · 研究领域：PARP inhibition in cancer therapy、Ovarian cancer diagnosis and treatment、BRCA gene mutations in cancer

LBA5506 Background: Olaparib (ola) maintenance (mtx) improved outcomes in pts with newly diagnosed AOC and a BRCAm (DiSilvestro J Clin Oncol 2023;41:609–17) or with bev in pts with homologous recombination deficiency (HRD+) tumors (Ray-Coquard Ann Oncol 2022: LBA29) in response to 1L treatment, but an unmet need remains. Combining an immune checkpoint inhibitor with an antiangiogenic agent and a PARP inhibitor may enhance antitumor effect (Banerjee Ann Oncol 2022: 529MO). The Phase III DUO-O trial (NCT03737643) evaluates PC + bev + durva, followed by mtx bev + durva + ola, in pts with non-tBRCAm AOC in the 1L setting. Methods: Pts had newly diagnosed FIGO stage III or IV, high-grade epithelial, non-tBRCAm AOC and had completed upfront, or were planned to receive interval, debulking surgery and 1 cycle of PC ± bev. At Cycle 2, pts were randomized 1:1:1 to Arm 1: PC + bev (15 mg/kg IV q3w) + durva pbo (up to 6 cycles) followed by mtx bev (15 mg/kg IV q3w; total 15 months [mo]) + durva pbo (total 24 mo) + ola pbo (total 24 mo); Arm 2: PC + bev + durva (1120 mg IV q3w) followed by mtx bev + durva (1120 mg IV q3w) + ola pbo; or Arm 3: PC + bev + durva followed by mtx bev + durva + ola (300 mg bid tablets). The primary endpoint, progression-free survival (PFS; modified RECIST 1.1 per investigator) in Arm 3 vs Arm 1, was tested first in the non-tBRCAm HRD+ population (GIS ≥42, Myriad MyChoice CDx) and then the intent-to-treat (ITT) population. Results: 1130 pts were randomized: 378 ...