The Committee for Medicinal Products for Human Use (CHMP) has recommended Zejula (niraparib) as a first-line maintenance therapy for women with advanced ovarian cancer who responded to platinum-based chemotherapy.
This favorable opinion by the committee, a branch of the European Medicines Agency (EMA), is one of the final steps of Zejula’s marketing authorization procedure that may lead to its approval by the European Commission. If approved, Zejula will be the first PARP inhibitor used as a first-line maintenance therapy for women with advanced platinum-responsive ovarian cancer, regardless of whether their tumors are defective in DNA repair.
“Only 20% of women with ovarian cancer are currently eligible to be treated with a PARP inhibitor in the first-line maintenance setting,” Axel Hoos, MD, PhD, senior vice president and head of oncology research and development at GlaxoSmithKline (GSK), which is developing Zejula, said in a press release.
“Today’s positive opinion from the CHMP will give all women in response to platinum-based chemotherapy the option to receive Zejula in the maintenance setting, reinforcing our belief in the important role this innovative medicine may play in helping these patients and the physicians working to treat them,” he added.
The committee’s favorable recommendation was based on data from the PRIMA Phase 3 trial (ENGOTOV26/GOG-3012; NCT02655016), which is assessing the efficacy of Zejula maintenance therapy in women with newly diagnosed advanced ovarian cancer who responded to platinum-based chemo.
Approximately half of the women enrolled in the study had tumors that contained mutations in the BRCA DNA repair genes.
From the 733 women who enrolled in PRIMA, 487 were randomly assigned to receive Zejula and 287 to a placebo, both given once daily in 28-day cycles, for 36 months or until disease progression.
Top-line data from PRIMA showed that in the overall population, Zejula significantly prolonged the time women lived without disease worsening from 8.2 to 13.8 months, effectively lowering the risk of disease progression or death by 38%.
These benefits were even higher among women whose tumors were defective in DNA repair genes, with Zejula reducing their risk of death or disease progression by 57%, and increasing the time they lived without disease progression from a median of 10.4 to 21.9 months.
Responses to Zejula were found to be strong and durable in all women, regardless of whether their tumors contained BRCA mutations.
More recently, two new analyses from PRIMA, presented at the 2020 European Society for Medical Oncology virtual congress, demonstrated that Zejula was equally safe and effective in older women (age 65 and older), and did not result in a decrease in quality of life compared to women receiving a placebo.
Zejula is an oral PARP inhibitor marketed by Tesaro, a subsidiary of GSK. It works by blocking the activity of PARP enzymes, which are involved in DNA repair. By inhibiting these enzymes, Zejula prevents cancer cells from repairing their DNA, eventually killing them.
The treatment had previously been approved in the U.S. and in Europe as a maintenance therapy for women with recurrent and high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who responded at least partially to platinum-based chemo.