Tesaro, Inc. (NASDAQ: TSRO) is watching its shares make a significant gain on Wednesday after the company released positive late-stage trial results. The company announced that its Phase 3 NOVA trial of niraparib successfully achieved its primary endpoint of progression-free survival (PFS).
Note that there is currently no therapy approved by the U.S. Food and Drug Administration (FDA) for maintenance treatment of patients with recurrent ovarian cancer following response to platinum, leaving a sizeable market open for Tesaro to take advantage of.
Unfortunately, the majority of women who are diagnosed with advanced ovarian cancer will experience a relapse of their disease, even if they respond to their initial chemotherapy.
As a result, new treatment options are needed to extend the time in between cycles of platinum-based chemotherapy for these patients, and the results from the NOVA study suggest that niraparib could represent an important new treatment option for many patients with ovarian cancer.
Ultimately, this trial demonstrated 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 but who 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.
Mary Lynne Hedley, Ph.D., President and COO of Tesaro, commented:
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. 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.
Shares of Tesaro were last trading up nearly 100% at $74.47, with a consensus analyst price target of $62.36 and a 52-week trading range of $29.51 to $66.95.
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