Tesaro’s ovarian cancer drug success threatens market rivals

pharmafile | October 12, 2016 | News story | Research and Development AbbVie, AstraZeneca, Pfizer, Roche, Tesaro, avastin, lynparza, niraparib, talazoparib, veliparib 

Phase III results from Tesaro’s niraparib PARP inhibitor could spell trouble for rivals Roche and AstraZeneca as its showed sizeable benefit in treating women with recurrent ovarian cancer with success in 70% of patients.

The treatment was found to significantly increase progression-free survival (PFS) in patients with platinum-sensitive recurrent ovarian cancer regardless of Breast Cancer Susceptibility Gene (BRCA) status, with a median PFS of 21 months versus 5.5 months for placebo. It was even beneficial in non-BRCA patients, with a PFS of 9.3 months versus 3.9 months.

“The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint in both cohorts, demonstrating that niraparib treatment significantly prolonged PFS compared to control in patients who were germline BRCA mutation (gBRCAmut) carriers and in patients who were not germline BRCA mutation (non-gBRCAmut) carriers,” the company said in a statement.

These results put pressure on other leading drugs in the class. AstraZeneca’s PARP inhibitor Lynparza (olaparib), the only other PARP inhibitor on the market, has shown a PFS of only a few months while working only in 15% of patients, being limited to BRCA-positive patients. Roche’s Avastin (bevacizumab) is also under threat, and with AbbVie’s veliparib and Pfizer’s talazoparib initially indicated for treatment of breast cancer, niraparib could run relatively unopposed in the market; a fact which sent Tesaro’s shares rocketing.

Lead investigator Dr Mansoor Raza Mirza of Copenhagen University Hospital in Denmark called the results “a breakthrough for patients,” commenting: “We have never seen such large benefits in PFS in recurrent ovarian cancer.”

The company is planning to seek approval for the drug before the year’s end.

Matt Fellows

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