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Clinical Trial
. 2025 Aug:199:96-102.
doi: 10.1016/j.ygyno.2025.06.014. Epub 2025 Jul 1.

A phase 2 trial of niraparib plus bevacizumab maintenance therapy following first-line platinum-based chemotherapy with bevacizumab in advanced ovarian cancer: final analysis and overall survival results from OVARIO

Melissa M Hardesty  1 , Thomas C Krivak  2 , Gail S Wright  3 , Erika Hamilton  4 , Evelyn L Fleming  5 , Jimmy Belotte  6 , Shelby Gorman  7 , Natalie Compton  8 , Aine Clements  9 , Heidi J Gray  10 , Gottfried E Konecny  11 , Richard G Moore  12 , Debra L Richardson  13
Affiliations
Free article
Clinical Trial

A phase 2 trial of niraparib plus bevacizumab maintenance therapy following first-line platinum-based chemotherapy with bevacizumab in advanced ovarian cancer: final analysis and overall survival results from OVARIO

Melissa M Hardesty et al. Gynecol Oncol. 2025 Aug.
Free article

Abstract

Objective: To report long-term outcomes from the OVARIO trial of niraparib plus bevacizumab maintenance following first-line platinum-based chemotherapy with bevacizumab in advanced ovarian cancer.

Methods: The phase 2, single-arm, open-label trial enrolled adult patients with stage IIIB-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer (NCT03326193). Patients were required to have attempted debulking surgery and have a complete or partial response or no evidence of disease following first-line, platinum-based chemotherapy with ≥3 cycles of bevacizumab. The primary endpoint was 18-month progression-free survival (PFS) rate, per RECIST. Secondary endpoints included PFS, overall survival (OS), safety, and health-related quality of life (HRQOL) as assessed by the Functional Assessment of Cancer Therapy-Ovarian Symptoms Index (FOSI). Final analysis cutoff date, August 12, 2024.

Results: The median duration of follow-up was 65.7 months. Among evaluable patients (N = 105), PFS results were consistent with the primary analysis. Median OS (95% CI) was 61.1 months (44.9 months-not evaluable [NE]; 52.4% maturity) in the overall population, NE (58.2 months-NE) in the homologous recombination-deficient, 38.7 months (21.9-63.8 months) in the homologous recombination-proficient, and 39.8 months (21.7 months-NE) in the homologous recombination status not determined subgroups. Most patients (73.3%) received subsequent anticancer therapy; 30.5% received subsequent PARP inhibitor therapy. No new safety signals were identified; safety remained consistent with the primary analysis. Per FOSI, HRQOL was not negatively affected.

Conclusion: In OVARIO, median OS was 61.1 months in the overall population. Safety was consistent with known safety profiles of niraparib and bevacizumab as monotherapies.

Keywords: Bevacizumab; Maintenance therapy; Niraparib; Ovarian cancer.

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Conflict of interest statement

Declaration of competing interest MM Hardesty reports consulting fees from AstraZeneca, Daiichi Sankyo, Eisai, GSK, ImmunoGen/AbbVie, MSD, Takeda, and Yanuvia; speaker fees from MSD; and uncompensated membership on the National Ovarian Cancer Coalition (NOCC) Medical & Scientific Advisory Board and various committees of the Society of Gynecologic Oncology (SGO). TC Krivak reports consulting and speakers' bureau fees from AbbVie, AstraZeneca, Genmab, GSK, and Pfizer; speaking fees from MSD and Myriad Genetics; and research support from AstraZeneca, MSD, and Myriad Genetics. GS Wright reports institutional grants from AbbVie, AstraZeneca, Daiichi Sankyo, Dana Farber Cancer Institute, G1 Therapeutics, Genentech, Genmab, Gilead, H3 Biomedicine, HUTCHMED, ImmunoGen/AbbVie, Lilly, MacroGenics, Merrimack Pharmaceuticals, NanoString Technologies, Novartis, Odonate Therapeutics, Pfizer, Roche, Sarah Cannon Research Institute, Seagen/Pfizer, Taiho Oncology, and Tesaro/GSK and advisory board fees from Novartis. E Hamilton reports institutional research funding from AbbVie, Acerta Pharma, Accutar Biotechnology, ADC Therapeutics, Akeso, Amgen, Aravive, ArQule/MSD, Artios Pharma, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond Therapeutics, BlissBio, Boehringer Ingelheim, Bristol Myers Squibb, Cascadian Therapeutics/Seagen/Pfizer, Clovis Oncology, Compugen, Context Therapeutics, Cullinan Therapeutics, Curis, CytomX Therapeutics, Daiichi Sankyo, Dana Farber Cancer Institute, Dantari, Deciphera, DualityBio, eFFECTOR Therapeutics, Ellipses Pharma, Elucida Oncology, EMD Serono, Eisai, Fochon Pharmaceuticals, Fosun Orinove, Fujifilm, G1 Therapeutics, Gilead Sciences, H3 Biomedicine, Harpoon Therapeutics/MSD, HUTCHMED, ImmunoGen/AbbVie, Immunomedics/Gilead Sciences, Incyte, Infinity Pharmaceuticals, Inspirna, InventisBio, Jacobio Pharma, Karyopharm Therapeutics, K-Group Beta, Kind Pharmaceuticals, Leap Therapeutics, Lilly, LOXO Oncology/Lilly, Lycera, Mabspace Biosciences, MacroGenics, MedImmune/AstraZeneca, Mersana Therapeutics, Merus, Millennium, Molecular Templates, Myriad Genetics, Novartis, NuCana, Olema Oncology, OncoMed Pharmaceuticals/Mereo BioPharma, ORIC Pharmaceuticals, Orum Therapeutics, Pfizer, PharmaMar, Pieris Pharmaceuticals, Pionyr Immunotherapeutics/Ikena Oncology, Plexxikon, Prelude Therapeutics, Profound Bio/Genmab, Radius Health, Regeneron, Relay Therapeutics, Repertoire Immune Medicine, Roche/Genentech, Seagen/Pfizer, Sermonix Pharmaceuticals, Shattuck Labs, Silverback Therapeutics/ARS Pharmaceuticals, StemCentRx/AbbVie, Stemline/Menarini Group, Sutro Biopharma, Syndax, Syros Pharmaceuticals, Taiho Oncology, TapImmune/Marker Therapeutics, Tesaro/GSK, Tolmar, Torque Therapeutics/Repertoire Immune Medicines, Treadwell Therapeutics, Verastem Oncology, Zenith Epigenetics, and Zymeworks; and consulting fees from Accutar Biotechnology, Arvinas, AstraZeneca, Circle Pharma, Daiichi Sankyo, Entos Pharmaceuticals, Gilead Sciences, IQVIA, Janssen/Johnson & Johnson Innovative Medicine, Jazz Pharmaceuticals, Jefferies, Johnson & Johnson, Lilly, Medical Pharma Services (MphaR), Mersana Therapeutics, Olema Oncology, Pfizer, Roche/Genentech, Shorla Oncology, Stemline/Menarini Group, Tempus, Theratechnologies, Tubulis, and Zentalis Pharmaceuticals. EL Fleming has nothing to disclose. J Belotte is employed by GSK and holds financial equities in GSK. S Gorman is employed by GSK and holds financial equities in GSK. N Compton is a former employee of, owns stock in, and is currently receiving consulting fees from GSK. A Clements has nothing to disclose. HJ Gray reports royalites from UpToDate and fees from OncLive. GE Konecny reports clinical trial funding from Lilly and MSD and speaker fees from AbbVie, AstraZeneca, and MSD. RG Moore reports consulting fees from Fujirebio. DL Richardson reports institutional research support from A2A Pharmaceuticals, Aadi Bioscience, Acrivon Therapeutics, Allorion Therapeutics, AstraZeneca, Blueprint Medicines, CanariaBio, Celsion/Imunon, DualityBio, GSK, HOOKIPA Pharma, ImmuoGen/AbbVie, Karyopharm Therapeutics, Lilly, Mersana Therapeutics, Nimbus Therapeutics, Nurix Therapeutics, OnCusp Therapeutics, PMV Pharmaceuticals, Profound Bio, Scorpion Therapeutics, Shattuck Labs, Syros Pharmaceuticals, and Valerio Therapeutics; consulting fees from Mersana Therapeutics; speaker fees from Zentalis Pharmaceuticals; travel support from Genmab; advisory board fees from Daiichi Sankyo, Eisai, Genmab, GSK, ImmunoGen/AbbVie, Incyclix Bio, and Profound Bio; and membership on the SGO Board of Directors and the NOCC Board of Directors.

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