Triplet maintenance therapy of olaparib, pembrolizumab and bevacizumab in women with BRCA wild-type, platinum-sensitive recurrent ovarian cancer: the multicenter, single-arm phase II study OPEB-01/APGOT-OV4

Yoo-Na Kim, Boram Park, Jae Weon Kim, Byoung Gie Kim, Sang Wun Kim, Hee Seung Kim, Chel Hun Choi, Myong Cheol Lim, Natalie YL Ngoi, David SP Tan and Jung-Yun Lee ()
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Yoo-Na Kim: Yonsei University College of Medicine
Boram Park: Samsung Medical Center
Jae Weon Kim: Seoul National University
Byoung Gie Kim: Sungkyunkwan University School of Medicine
Sang Wun Kim: Yonsei University College of Medicine
Hee Seung Kim: Seoul National University
Chel Hun Choi: Sungkyunkwan University School of Medicine
Myong Cheol Lim: National Cancer Center
Natalie YL Ngoi: National University of Singapore
David SP Tan: National University of Singapore
Jung-Yun Lee: Yonsei University College of Medicine

Nature Communications, 2023, vol. 14, issue 1, 1-8

Abstract: Abstract In this multicenter, open-label, single-arm, Phase II study with Simon two-stage optimum design (NCT04361370), we investigate the efficacy and safety of triplet maintenance (olaparib, pembrolizumab, bevacizumab) in patients with platinum-sensitive recurrent ovarian cancer who are wild-type for BRCA 1/2. A total of 44 patients were enrolled, and the median follow-up duration was 22.9 months (interquartile range: 17.4–24.7). The primary outcome was 6-months progression-free survival (PFS), which was 88.6% (95% confidence interval [CI] 75.4–96.2), meeting the pre-specified primary endpoint. The secondary outcomes reported here include median PFS, 12-months PFS, and overall survival and safety. The median PFS was 22.4 months (20.4–∞), with a 12-months PFS rate of 84.0% (95% CI 69.3–92.0). The median overall survival was 28.6 months (27.3–∞). The combination demonstrated tolerable toxicity with manageable side effects. Other secondary outcomes include time-to-progression, time to subsequent treatment, time to second treatment and PFS2; however, this data is not reported, as treatment is still ongoing in a majority of patients. Exploratory analysis shows that patients who were homologous recombination deficiency-positive or had a programmed death-ligand 1 combined positive score ≥1 showed a favorable response (P = 0.043 and P

Date: 2023
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DOI: 10.1038/s41467-023-40829-2

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