TESARO Announces Positive Top-Line Results From Quadra Trial of ZEJULA

TESARO (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced results from the QUADRA study, which was designed to assess clinical benefit of ZEJULA® treatment in heavily pre-treated patients with ovarian cancer. Results successfully achieved the pre-specified primary endpoint and demonstrated ZEJULA monotherapy activity in a biomarker selected patient population.

As quoted in the press release:

Previous studies have shown PARP inhibitor activity in the late-line treatment of patients with BRCA mutations.  QUADRA, a single arm study (n=461), was conducted to assess the activity of ZEJULA monotherapy in the fourth-line plus treatment of specific ovarian cancer patient populations.  Of the 92% of QUADRA participants who were PARP inhibitor naïve, 15% had a BRCA mutation, over two-thirds were platinum resistant/refractory and 63% had received prior bevacizumab.

ZEJULA demonstrated activity in the primary efficacy population of fourth and fifth-line HRD positive patients who were PARP inhibitor naïve, and platinum sensitive (n=45), with an objective response rate (ORR) of 29%, and duration of response (DOR) of 9.2 months. In patients who were fourth line or greater with BRCA mutations, including platinum-sensitive, resistant and refractory, (n=55), the ORR was 31% and the median DOR was 9.4 months.

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