publication date: Aug. 4, 2016
Ovarian Cancer Niraparib Demonstrates Prolonged PFS In Phase III Trial, Achieving Primary Endpoint
Niraparib achieved its primary endpoint in a phase III ovarian cancer trial, demonstrating prolonged progression-free survival compared to placebo among patients who are germline BRCA mutation carriers; among patients who are not germline BRCA mutation carriers, but who have homologous recombination deficient tumors as determined by the Myriad myChoice HRD test; and overall in patients who are not germline BRCA mutation carriers.
The trial, NOVA, is a double-blind, international trial that enrolled more than 500 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. There is currently no therapy approved by FDA for maintenance treatment of patients with recurrent ovarian cancer following response to platinum, according to Tesaro Inc., niraparib’s sponsor. Niraparib is an oral, once-daily PARP inhibitor.
“Importantly, these results show activity of niraparib in a population of ovarian cancer patients beyond those with germline BRCA mutations,” said Mary Lynne Hedley, president and COO of Tesaro. The company expects to present the full data set at the annual congress of the European Society for Medical Oncology in October, and regulatory submissions are expected later this year.
Among patients who were germline BRCA mutation carriers, the niraparib arm demonstrated a median PFS of 21.0 months compared to 5.5 months in the placebo arm … Continue reading CCL July – Niraparib Demonstrates Prolonged PFS In Phase III Trial, Achieving Primary Endpoint
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