TESARO Spikes 110% After Its Drug Significantly Improved Progression-Free Survival For Ovarian Cancer Patients

TESARO, Inc. (TSRO) revealed that the Phase 3 NOVA trial of niraparib successfully achieved its primary endpoint of progression-free survival (PFS). According to the company, the study illustrated that niraparib significantly prolonged PFS compared to control among patients who are germline BRCA mutation (gBRCAmut) carriers, among patients who are not germline BRCA mutation (non-gBRCAmut) carriers. However, such patients might have homologous recombination deficient (HRD) tumors as determined by the Myriad myChoice HRD test, and overall in patients who are not germline BRCA mutation carriers. Following this, shares have more than doubled on Wednesday's trading.TESARO said that NOVA is a double-blind, placebo-controlled, international final stage study of niraparib, which enrolled over 500 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. The company said that there was no therapy that was approved by the FDA currently for maintenance treatment of patients with recurrent ovarian cancer following response to platinum.The company's President and COO, Mary Lynne Hedley, said, "We are extremely grateful to the patients, caregivers, and investigators who participated in the NOVA trial. The results of this study, which is the first successful, prospectively designed, randomized, well-controlled Phase 3 study of a PARP inhibitor, demonstrate that a single, daily, oral dose of niraparib is superior to control in prolonging PFS in women with recurrent ovarian cancer."He added, "Importantly, these results show activity of niraparib in a population of ovarian cancer patients beyond those with germline BRCA mutations. In keeping with our mission of responsible drug development, NOVA was designed to define those patients most likely to benefit from niraparib treatment and, in so doing, optimize the benefit/risk profile for patients. We believe we have achieved that goal and look forward to presentation of the full data set from this study at the European Society for Medical Oncology (ESMO) congress in October." At the time of writing the article, shares of the company climbed 113 percent.