Positive Results From QUADRA Trial of Niraparib in Ovarian Cancer
Tesaro recently announced results from the QUADRA study, which was designed to assess the clinical benefit of niraparib (Zejula) treatment in heavily pretreated patients with ovarian cancer. Results successfully achieved the prespecified primary endpoint and demonstrated niraparib monotherapy activity in a biomarker-selected patient population.
Previous studies have shown poly ADP-ribose polymerase (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 niraparib monotherapy in the fourth-line–plus treatment of specific ovarian cancer patient populations. Of the 92% of QUADRA participants who were PARP inhibitor–naive, 15% had a BRCA mutation, over two-thirds were platinum resistant/refractory, and 63% had received prior bevacizumab (Avastin).
Niraparib demonstrated activity in the primary efficacy population of fourth- and fifth-line homologous recombination deficiency (HRD)-positive patients who were PARP inhibitor–naive and platinum-sensitive (n = 45), with an objective response rate of 29% and duration of response of 9.2 months. In patients who were fourth-line or greater with BRCA mutations—including platinum-sensitive, resistant, and refractory (n = 55)—the objective response rate was 31% and the median duration of response was 9.4 months.
At a starting dose of 300 mg of niraparib, the most commonly observed adverse events were consistent with prior clinical experience and included myelosuppression, which was generally managed via dose modifications. Tesaro intends to discuss a biomarker-focused regulatory submission with the U.S. Food and Drug Administration for a potential supplemental New Drug Application in the second half of 2018.
About Niraparib
Niraparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, niraparib concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP1 and PARP2 and a persistent antitumor effect.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
