cancerstudy

Tesaro’s niraparib hits primary goal in late-stage trials for ovarian cancer trial; shares jump

pharmafile | June 30, 2016 | News story | Research and Development, Sales and Marketing |  Tesaro, drug trial, niraparib, ovarian cancer 

Shares in Tesaro (Nasdaq: TSRO) jumped to more than double after the company reported late-stage trials for its drug to treat ovarian cancer met its primary endpoint of progression-free survival (PFS).

The company said a Phase III study of niraparib showed the trial drug significantly prolonged PFS compared to control among patients who are germline BRCA mutation carriers.

Tesaro said it is planning US and EU marketing submissions for the oral PARP inhibitor.

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Mary Lynne Hedley, chief operating officer of Tesaro, said: “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.”   

In the trial, more than 500 patients with recurrent ovarian cancer who responded to their most recent platinum-based chemotherapy were randomised to treatment with niraparib.

Dr. Tom Herzog, Clinical Director, University of Cincinnati Cancer Institute said: “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. 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.”

About 22,000 women are diagnosed each year with ovarian cancer in the US, and nearly 80% are diagnosed after the disease has become symptomatic and has progressed to a late stage. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, 90% of patients will experience recurrence within two years. S

Shares in the company closed up $40.2 at $77.4 on Wednesday on the Nasdaq.

Anjali Shukla

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