The European Commission has approved Tesaro‘s Zejula (niraparib) as a maintenance treatment for ovarian cancer, with or without BCRA mutations, in women who have shown a complete or partial response to platinum-based chemotherapy.
The treatment was approved as a stand-alone therapy for adult patients with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancers. This follows Zejula’s approval in the U.S. for the same indication in March 2017.
“With the introduction of Zejula, treatment of women with recurrent ovarian cancer will improve markedly,” Andreas Du Bois, MD, center director of gynecology and gynecologic oncology at Kliniken Essen-Mitte in Germany, and co-founder and past chair of the European Network of Gynecological Oncological Trial Groups (ENGOT), said in a press release. “Patients and their physicians are now empowered with an additional option to utilize after a response to chemotherapy, regardless of BRCA mutation status, where the previous alternative for most was a period of watching and waiting instead of actively controlling their disease.”
The approvals were based on results from the Phase 3 ENGOT-OV16/NOVA trial (NCT01847274), which tested if Zejula was better than a placebo at delaying disease progression in ovarian cancer patients who had responded to platinum-based chemotherapy.
The study enrolled 553 patients with recurrent ovarian cancer who received once-daily Zejula or placebo until their tumor progressed. Patients were divided into two groups, based on their inherited BRCA mutation status.
While progression-free survival (PFS) was the trial’s main goal, researchers also assessed overall survival, patient-reported outcomes, and chemotherapy-free interval as secondary measures.
The full results from the Phase 3 trial were presented last year during the ESMO Congress and simultaneously published in The New England Journal of Medicine.
Zejula was significantly better than the placebo at delaying disease progression. In women with BRCA-positive tumors, Zejula reduced the risk of disease progression by 74%. Those taking Zejula had a median PFS of 21 months compared to 5.5 months in the placebo arm.
For women with BRCA-negative tumors, the figures were 9.3 months for Zejula and 3.9 months for placebo, representing a 55% reduction in the risk of progression.
Significant improvements were also seen in chemotherapy-free interval and overall survival, but no differences were seen in measures of quality of life.
“We want to express our gratitude to all of the women who selflessly participated in the Zejula clinical development program. I would also like to thank our partners at ENGOT for their diligence in conducting the ENGOT-OV16/NOVA trial, which was carried out with the highest level of scientific rigor,” said Mary Lynne Hedley, PhD, president and chief operating officer of TESARO. “The unique design of this trial, which included women both with and without germline BRCA mutations, allowed us to independently determine that Zejula provides significant progression-free survival improvement in a very broad patient population.”
“The EC approval of Zejula marks TESARO’s second product approval in Europe this year. We are committed to working with healthcare providers, payers and patient groups to enable access to this paradigm-changing treatment as quickly as possible,” she added.
Zejula is a poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor taken orally once daily. It is currently the most frequently prescribed PARP inhibitor for patients with ovarian cancer in the U.S.