The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Zejula (niraparib; GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
The approval was based on data from a multicenter, double-blind, placebo-controlled phase 3 study (PRIMA) that evaluated the efficacy of Zejula as maintenance treatment in 733 patients with advanced ovarian cancer following a complete or partial response to platinum-based chemotherapy. Patients were randomized 2:1 to receive either Zejula or placebo once daily. The primary end point was progression-free survival (PFS) analyzed sequentially in the homologous recombination deficient (HRd; defined by either presence of tumor breast cancer susceptibility gene mutation or genomic instability score ≥42) population, then in the overall population.
Results showed a statistically significant improvement in PFS for Zejula compared with placebo, regardless of biomarker status. The median PFS in the HRd population was 21.9 months for the Zejula arm compared with 10.4 months for placebo (HR 0.43; 95% CI, 0.31-0.59; P <.0001). In the overall population, the median PFS was 13.8 months for the Zejula arm compared with 8.2 months for placebo (HR 0.62; 95% CI, 0.50-0.76; P <.0001). In addition, findings from a 24-month interim analysis showed an 84% overall survival rate in the Zejula group vs 77% in the placebo group (hazard ratio 0.70; 95% CI, 0.44-1.11).
“The positive data observed regardless of biomarker status in this study is extremely encouraging and suggests benefit beyond the BRCAm population,” said PRIMA investigator Dr Bradley Monk, US Oncology, University of Arizona College of Medicine, Phoenix Creighton University School of Medicine at St. Joseph’s Hospital Phoenix. “In my opinion, maintenance treatment with niraparib should be considered an option for appropriate patients who responded to first-line platinum-based chemotherapy versus active surveillance.”
The safety profile of Zejula was consistent with that seen in previous trials. The most common adverse reactions of grade 3 or higher were thrombocytopenia (39%), anemia (31%) and neutropenia (21%).
Zejula, a poly(ADP-ribose) polymerase (PARP) inhibitor, is also approved for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. It is also indicated for the treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens and whose cancer is associated with HRd positive status.
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