Dr Matulonis on Second-line Maintenance Therapy With Niraparib in Ovarian Cancer

Ursula A. Matulonis, MD, chief, Division of Gynecologic Oncology, Brock-Wilson Family Chair, Dana-Farber Cancer Institute; professor, medicine, Harvard Medical School, discusses final overall survival (OS) results from the phase 3 NOVA trial (NCT01847274) in patients with ovarian cancer.

The NOVA trial studied niraparib (Zejula) vs placebo in patients with platinum-sensitive, recurrent ovarian cancer with or without germline BRCA mutations, with a primary end point of progression-free survival (PFS).

Primary findings from NOVA, which were published in the New England Journal of Medicine in 2016, showed that patients who received niraparib had improved PFS, regardless of their underlying BRCA mutation status or homologous recombination repair status, Matulonis says. With niraparib, the median PFS was 21.0 months and 9.3 months in the germline BRCA mutated and non–germline BRCA mutated cohorts, respectively, vs 5.5 months and 3.9 months with placebo, respectively. These findings supported the 2017 FDA approval of niraparib maintenance in adult patients with epithelial ovarian cancer who achieved complete or partial response to platinum-based chemotherapy.

The updated OS data, presented at the 2021 SGO Meeting of Women’s Cancer, showed that patients who received niraparib had a median OS of 43.8 months and 31.3 months vs 34.1 months and 35.9 months with placebo in the germline BRCA mutated and non–germline BRCA mutated cohorts, respectively. Based on these findings, the FDA restricted the approval of second-line maintenance niraparib in ovarian cancer to only patients with germline BRCA mutations.

Notably, the 2021 OS data were limited, as 17% of survival data were missing, Matulonis explains. To rectify this, the NOVA investigators obtained many of these missing data from the participating institutions, reducing the percentage of missing OS data to around 2%, Matulonis emphasizes. These final OS data show a median OS of 40.9 months in patients with germline BRCA mutations who received niraparib vs 38.1 months in those who received placebo, with a hazard ratio of 0.85, Matulonis concludes.

Editor’s Note: Dr Matulonis reports consulting fees from Agenus, AstraZeneca, Blueprint Medicines, Boehringer Ingelheim, GSK, Merck, NextCure, Novartis, and Trillium; and data and safety monitoring board participation for Advaxis, Alkermes, and Symphogen. This study was sponsored by GSK.