OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab

Author(s): Melissa M.Hardesty^a Thomas C.Krivak^b Gail S.Wright^c ErikaHamilton^d Evelyn L.Fleming^e JimmyBelotte^f Erika K.Keeton^g PingWang^f DivyaGupta^f AineClements^h Heidi J.Grayⁱ Gottfried E.Konecny^j Richard G.Moore^k Debra L.Richardson^l

Source: https://doi.org/10.1016/j.ygyno.2022.05.020

FCS hematologist and medical oncologist Gail Wright, MD, FACP, FCCP co-authored a recent phase II study assessing the safety and efficacy of niraparib + bevacizumab as a first-line maintenance therapy for patients with newly diagnosed advanced ovarian cancer. The promising results found the majority to be progression-free in the first 18 months.

HIGHLIGHTS

OVARIO enrolled patients with primary advanced-stage ovarian cancer, including high-risk cases.
In the overall population, 62% of patients were progression-free at the 18-month primary endpoint.
After a median follow-up of 28.7 months, median PFS was 19.6 months (overall), 28.3 months (HRd), and 14.2 months (HRp).
The most common any-grade adverse events related to niraparib and/or bevacizumab were thrombocytopenia, fatigue, and anemia.

ABSTRACT

OBJECTIVE

To assess safety and efficacy of niraparib + bevacizumab as a first-line maintenance therapy for patients with newly diagnosed advanced ovarian cancer.

METHODS

This multicenter, phase II, single-arm, open-label study enrolled adult patients with stage IIIB to IV ovarian, fallopian tube, or primary peritoneal cancer (NCT03326193). Patients were required to have an attempt at debulking surgery and have a complete response, partial response, or no evidence of disease following first-line, platinum-based chemotherapy with ≥3 cycles of bevacizumab. The primary endpoint was the progression-free survival (PFS) rate at 18 months. Secondary endpoints included PFS, overall survival, and safety.

RESULTS

Among the 105 evaluable patients, the PFS rate at 18 months was 62% (95% CI 52–71%) in the overall population and 76% (95% CI 61–87) in the homologous recombination deficient (HRd), 47% (95% CI 31–64%) in the HR proficient (HRp), and 56% (95% CI 31–79%) in the HR not determined (HRnd) subgroups (December 24, 2020, cutoff). After a median follow-up time of 28.7 months (IQR, 23.9–32.5 months), median PFS was 19.6 months (95% CI 16.5–25.1) in the overall population (N = 105) and 28.3 months (95% CI 19.9–NE), 14.2 months (95% CI 8.6–16.8), and 12.1 months (95% CI 8.0–NE) in the HRd, HRp, and HRnd subgroups, respectively (June 16, 2021, cutoff). The most common any-grade treatment-related adverse events (related to niraparib and/or bevacizumab) were thrombocytopenia (74/105), fatigue (60/105), and anemia (55/105; December 24, 2020, cutoff).

CONCLUSION

Niraparib + bevacizumab first-line maintenance therapy displayed promising PFS results. Safety was consistent with the known safety profiles of niraparib and bevacizumab as monotherapy.

Author Affiliations

^a Alaska Women’s Cancer Care, Anchorage, AK, USA ^b Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Western Pennsylvania Hospital, Pittsburgh, PA, USA ^c Florida Cancer Specialists and Research Institute, New Port Richey, FL, USA ^d Medical Oncology, Sarah Cannon Research Institute, Tennessee Oncology, Nashville, TN, USA^e Division of Gynecologic Oncology, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA ^f GlaxoSmithKline, Waltham, MA, USA ^g GlaxoSmithKline, Waltham, MA, USA at the time the analysis was conducted ^h Department of Gynecologic Oncology, Riverside Methodist Hospital, Columbus, OH, USAⁱ Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA ^j University of California, Los Angeles, Los Angeles, CA, USA^k Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA ^l Division of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA

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