Oncology-focused biopharmaceutical company Tesaro has started patient enrolment in a Phase III trial of an inhibitor of poly ADP-ribose polymerase (PARP), niraparib, for ovarian cancer.
Referred to as Niraparib Ovarian (NOVA), the study is designed to assess a single daily 300mg dose of niraparib in 360 patients with high grade serous, platinum sensitive, relapsed ovarian cancer against placebo.
Tesaro president Dr Mary Lynne Hedley said: "This milestone represents a significant advance in the progression of TESARO’s pipeline and brings us closer to our goal of delivering new oncology therapies to patients."
The double blind, placebo-controlled, international trial of niraparib will enrol 360 patients into one of the two independent cohorts based on germline BRCA mutation status.
Patients will be randomised to receive niraparib or placebo in the ratio 2:1 within each cohort and the treatment will continue until progression.
The study’s primary endpoint is progression free survival and secondary endpoints include patient reported outcomes, chemotherapy free interval length, and overall survival.
At the recommended dose, Phase I trial of niraparib demonstrated that a RECIST response rate of 75% was observed with platinum sensitive high grade serous ovarian cancer, 46% in the population across all dose levels and 50% in patients with platinum sensitive ovarian cancer and germline BRCA mutations.
The study, in which Niraparib was well tolerated, noted a median duration of response of 431 days for platinum sensitive germline BRCA patients and 444 days for platinum sensitive patients who were not germline BRCA mutation carriers.
Image: An ovarian cancer as seen on CT. Photo: courtesy of James Heilman.