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TESARO’s Niraparib Significantly Improved Progression-Free Survival For Patients With Ovarian Cancer In Both Cohorts Of The Phase 3 NOVA Trial

Shanghai Biopharmaleader Co.,Ltd | Updated: Jun 30, 2016
  • The NOVA trial successfully achieved its primary endpoint of PFS in the germline BRCA mutant cohort  

  • The NOVA trial successfully achieved its primary endpoint of PFS in the non-germline BRCA mutant cohort, including both the HRD-positive and overall analysis populations

  • NOVA is the first successful prospectively designed Phase 3 trial of a PARP inhibitor

  • NDA and MAA submissions are planned for Q4 2016

WALTHAM, Mass., June 29, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (TSRO), an oncology-focused biopharmaceutical company, today announced that the Phase 3 NOVA trial of niraparib successfully achieved its primary endpoint of progression-free survival (PFS). 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.

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