Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Tesaro, an oncology-focused biopharmaceutical company, provided an update on its niraparib clinical development program.
Subscribe to our email newsletter
The targeted enrollment has been achieved in both patient cohorts of the Phase 3 NOVA trial of niraparib, and TESARO expects data from NOVA in the fourth quarter of 2015. In addition, the QUADRA treatment trial of niraparib has been initiated, and initial data from this trial is anticipated in early 2016.
Tesaro president and COO Mary Lynne Hedley said: "Our goal is to establish a broad franchise in ovarian cancer by evaluating niraparib in several patient populations and across multiple potential indications.
"We expect data from the Nova trial in the fourth quarter of this year, the Quadra and Avanova trials are currently underway, and planning is ongoing to support initiation of the Prima trial of niraparib in the first-line ovarian cancer maintenance during the second half of this year."
The Nova (Niraparib Ovarian) study is a double blind, placebo-controlled, international Phase 3 trial of niraparib with a target enrollment of 490 patients with high grade serous, platinum sensitive, relapsed ovarian cancer.
Patients were enrolled into one of two independent cohorts based on germline BRCA mutation status. Within each cohort, patients were be randomized 2:1 to receive niraparib or placebo, and will be continuously treated with placebo or 300 milligrams of niraparib until progression.
The primary endpoint of this study is progression free survival. Secondary endpoints include patient reported outcomes, chemotherapy free interval length, and overall survival.
The Quadra study is a single arm, Phase 2 clinical trial that is targeted to enroll 225 patients with high grade serous ovarian cancer who have received three or more prior lines of chemotherapy.
Endpoints include objective response rate (ORR) and duration of response for the entire population, as well as for platinum sensitive, platinum resistant, germline BRCA and HRD (homologous recombination deficient) patient subsets.
Avanova is a Phase 1/2 trial designed to evaluate the efficacy of niraparib in combination with bevacizumab in approximately 147 patients with recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer.
In the phase 1 open label, dose escalation portion of this study, patients will receive a combination of bevacizumab plus niraparib, with a goal of determining the dose for Phase 2.
In the Phase 2 portion of the study, patients will be randomized to receive niraparib and/or the niraparib-bevacizumab combination or bevacizumab alone. The primary endpoint of this trial is PFS. This trial is being conducted in collaboration with The European Network for Gynaecological Oncological Trial groups (ENGOT).