Chicago, Illinois—According to recent findings being presented at the 2019 ASCO Annual Meeting, niraparib administered in combination with bevacizumab had meaningful activity and led to significant improvements in progression-free survival (PFS) compared with niraparib alone in women with platinum-sensitive recurrent ovarian cancer.

“Standard treatment of platinum-sensitive recurrent ovarian cancer…is platinum-based combination chemotherapy ± bevacizumab,” explained Mansoor Raza Mirza, MD, Chief Oncologist at Rigshopitalet, Copenhagen University Hospital, Denmark, and colleagues.

“However, this treatment modality is hardly curative, and is associated with significant toxicity,” they added.

According to Dr Mirza et al, bevacizumab and PARP inhibitors have demonstrated efficacy in platinum-sensitive recurrent ovarian cancer. Furthermore, they note that there is preclinical evidence of enhanced activity with the combination treatment.

To determine the best line of treatment for patients with platinum-sensitive recurrent ovarian cancer, Dr Mirza and his colleagues conducted an open-label, phase 2 trial in which they observed women with measurable and evaluable, high-grade serous, or endometrioid platinum-sensitive recurrent ovarian cancer.

The study participants were randomized to receive niraparib 300 mg once daily or the combination of niraparib 300 mg once daily and bevacizumab 15 mg/kg every 3 weeks until disease progression. PFS was the primary end point of the study.

According to Dr Mirza and colleagues, patients were stratified based on homologous recombination-deficiency (HRD) status and chemotherapy-free-interval (ie, 6-12 months vs >12 months).

Of note, first-line maintenance therapy with bevacizumab was allowed.

The research team enrolled 97 patients who met study criteria; of these patients, 48 were given niraparib monotherapy and 49 received the combination treatment. Findings showed that the combined treatment significantly improved PFS compared with niraparib alone (median, 11.9 months vs 5.5 months, respectively; hazard ratio [HR], adjusted for stratification factors 0.35; 95% CI, 0.21-0.57; P <.001).

Of note, Dr Mirza et al observed differences in the treatment-emergent grade 3-4 adverse events (except for the rate of hypertension and neutropenia). In addition, patient-reported outcomes were similar in both treatment arms.

“Compared to niraparib alone, the chemotherapy-free regimen of niraparib and [bevacizumab] significantly improved PFS in women with PSROC [platinum-sensitive recurrent ovarian cancer], regardless of HRD status and duration of [chemotherapy-free-interval],” Dr Mirza and colleagues concluded.—Julie Gould

Mirza MR, Avall-Lundqvist E, Birrer MJ, et al. Combination of niraparib and bevacizumab versus niraparib alone as treatment of recurrent platinum-sensitive ovarian cancer: A randomized controlled chemotherapy-free study—NSGO-AVANOVA2/ENGOT-OV24. Presented at: the 2019 ASCO Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 5505.