GSK announces USFDA committee to review Zejula overall survival data from NOVA phase III trial in recurrent ovarian cancer
UK: GSK plc has announced that the US Food and Drug Administration (USFDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss overall survival (OS) data from the ENGOT-OV16/NOVA phase III clinical trial. NOVA is a randomised, double-blind, placebo-controlled phase III trial of Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the maintenance treatment of women with platinum-sensitive recurrent ovarian cancer.
The phase III NOVA trial met the primary endpoint of progression-free survival (PFS) in both the gBRCAm and non-gBRCAm cohorts, demonstrating a statistically significant and clinically meaningful treatment effect of Zejula in this patient population, regardless of biomarker status. These PFS results served as the primary basis for the USFDA approval for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Overall survival was a secondary endpoint. Updated final overall survival data was recently shared with the FDA.
Ovarian cancer is the eighth most common cancer in women worldwide. Despite high response rates to platinum-based chemotherapy in the front-line setting, approximately 85% of patients will experience disease recurrence. Once the disease recurs, it is rarely curable, with decreasing time intervals to each subsequent recurrence.
Hesham Abdullah, SVP, Global Head of Oncology Development, GSK said: "We believe PARP inhibitors, including Zejula, are important options for the maintenance treatment of patients with recurrent ovarian cancer, across all biomarker subgroups, who are in complete or partial response to platinum-based chemotherapy. We look forward to continuing our ongoing discussions with the FDA."
The ODAC meeting is scheduled for 22 November 2022. This is not related to the niraparib indication in 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.
