Shares of Tesaro, Inc. surged 108% after the company announced that its phase III trial, NOVA, on oncology drug niraparib successfully achieved the primary endpoint of progression-free survival (PFS).
The double-blind, placebo-controlled, international trial (n>500) was designed to define those patients who are most likely to benefit from niraparib. The trial evaluated niraparib in patients suffering from recurrent ovarian cancer who were in response to their most recent platinum-based chemotherapy. The trial showed that niraparib significantly prolonged PFS compared to placebo among various cohorts – patients who are germline BRCA mutation carriers, 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. Hence, the trial demonstrates that a single, daily, oral dose of niraparib is much superior in prolonging PFS in women with recurrent ovarian cancer.
The company will present full results from the trial at the European Society for Medical Oncology (ESMO) congress in Oct 2016. The company also plans to submit its New Drug Application (NDA) and Marketing Authorization Application (MAA) on niraparib in the fourth quarter of 2016.
Nearly 22,000 women are diagnosed with ovarian cancer in the U.S. every year, while 80% are diagnosed after the disease has become symptomatic and has progressed to a late stage. Moreover, majority of the women who are diagnosed with advanced ovarian cancer are likely to experience a relapse of their disease.
This underscores the need for new treatment options to extend the time between the cycles of platinum-based chemotherapy for these patients. As per the company, there is currently no approved therapy in the U.S. for the maintenance treatment of patients with recurrent ovarian cancer following response to platinum. Hence, the successful phase III trial results bode well for Tesaro as a potential approval of niraparib will boost its portfolio.
We note that the FDA approved Tesaro’s first commercial product, Varubi, for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in Sep 2015.
Tesaro currently carries a Zacks Rank #4 (Sell). Investors interested in the healthcare sector may consider stocks like Pfizer, Inc. (PFE - Free Report) , Bristol-Myers Squibb Co. (BMY - Free Report) and Johnson & Johnson (JNJ - Free Report) . While Pfizer and Bristol-Myers sport a Zacks Rank #1 (Strong Buy), Johnson & Johnson is a Zacks Rank #2 (Buy) stock.
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