Tesaro will present three abstracts with results from the ENGOT-OV16/NOVA trial evaluating the effectiveness of Zejula (niraparib) in patients with recurrent ovarian cancer at the upcoming 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.
The company will also host an investor and analyst briefing to provide a business overview and an update on its product pipeline at the conference, being held June 2-6 in Chicago. The investor briefing will be recorded live and will be available online for 30 days on Tesaro’s website.
In March this year, the U.S. Food and Drug Administration (FDA) approved Zejula as a maintenance therapy for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
“We’re excited to see presentations of additional data from the landmark ENGOT-OV16/NOVA trial presented at this year’s ASCO Annual Meeting,” Mary Lynne Hedley, PhD, the president and chief operating officer of Tesaro, said in a press release.
“We also look forward to sharing initial data from the TOPACIO trial of niraparib plus pembrolizumab, as well as data from the Phase 1 trial of TSR-042, our anti-PD-1 antibody, at our ASCO investor briefing.”
Zejula is a PARP inhibitor and promotes cancer cell death by preventing proper repair of DNA damage. It has emerged as a promising therapy for ovarian cancer patients with low frequency of severe side effects.
The Phase 3 ENGOT-OV16/NOVA trial (NCT01847274) is a randomized, double-blind, placebo-controlled study evaluating the safety and effectiveness of Zejula maintenance therapy in 553 patients with recurrent ovarian cancer who responded to prior platinum-based therapy.
Participants were assigned to specific cohorts based on their BRCA mutation status, and were randomized to receive either Zejula (300 mg once daily) or placebo.
Results presented October 2016 at the ESMO Congress showed that Zejula more than tripled the time to disease progression or death in patients with BRCA mutations (21 months vs. 5.5 months). Among patients without BRCA mutations, Zejula also significantly improved progression-free survival, from 3.9 months to 9.3 months.
In Europe, maintenance therapy following response to platinum-based chemotherapy is standard, but in the U.S. it is only considered after a complete response.
But the study, “Efficacy of Niraparib on Progression-free Survival (PFS) in Patients (Pts) with Recurrent Ovarian Cancer (OC) with Partial Response to the Last Platinum-based Chemotherapy,” has shown that patients who exhibit only a partial response to chemotherapy also significantly benefit from Zejula maintenance.
In another study, titled “The Successful Phase 3 Niraparib ENGOT-OV16/NOVA Trial Included a Substantial Number of Patients with Platinum Resistant Ovarian Cancer,” researchers further characterized the ENGOT-OV16/NOVA trial population to determine platinum resistance status. Platinum resistance was defined as duration of response of six months or less to the most recent platinum regimen.
Their findings showed that nearly half of patients enrolled in the trial developed platinum resistance. Still, Zejula met its primary endpoint of progression-free survival, suggesting these patients also benefit from the maintenance therapy.
Finally, in the study “Long-Term Benefit of Niraparib Treatment of Recurrent Ovarian Cancer (OC),” researchers examined Zejula’s long-term effects and its impact on subsequent therapies after progression.
The study showed that patients treated with Zejula had long-term benefits compared to placebo, regardless of BRCA mutations or other mutations in DNA repair genes. The treatment did not reduce the ability of patients to benefit from subsequent therapies.
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