Cancer drug gets approval: Sales expected in billions

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WALTHAM, MA: TESARO, Inc. (NASDAQ: TSRO) today announced a substantial expansion of its niraparib clinical development program. Following the landmark results of the Phase 3 NOVA trial of niraparib, a comprehensive portfolio review, and the FDA approval of ZEJULA™ (niraparib) for patients with recurrent ovarian cancer, TESARO is implementing its plans to initiate registration strategies in the settings of metastatic ovarian, breast and lung cancers.

“Based on the unprecedented results of the NOVA trial in women with recurrent ovarian cancer, we previously announced the expansion and refinement of our PRIMA and QUADRA trials to include a broad patient population, and in the case of PRIMA, eliminated the enrollment requirement for a biomarker selected tumor. With the approval of ZEJULA in hand, we will now begin to execute on our plans to pursue potentially transformational applications of niraparib in a broad range of metastatic cancer indications,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “We plan to expand our first-line ovarian cancer strategy to include a combination study that assesses the potential benefit of niraparib plus an anti-PD-1 antibody in the maintenance setting and initiate a clinical study of niraparib in combination with bevacizumab in patients with a first recurrence of ovarian cancer, with an intent to replace chemotherapy in this setting. We remain strongly committed to studying niraparib in the breast cancer setting and also expect to initiate a new trial of niraparib in combination with an anti-PD-1 antibody in women with metastatic triple-negative breast cancer. Finally, our goal to move niraparib into indications beyond ovarian and breast cancers encompasses plans to initiate a registration strategy for the first-line treatment of patients with metastatic non-small cell lung cancer that includes a phase 2 trial of niraparib in combination with an anti-PD-1 antibody in patients, regardless of PDL-1 tumor expression, and a phase 3 trial of niraparib in combination with an anti-PD-1 antibody in patients with high levels of PDL-1 tumor expression.”

Niraparib is the only PARP inhibitor approved in the U.S. for the maintenance treatment of women with recurrent ovarian, fallopian or primary peritoneal cancers. This approval was based upon the results of a randomized, prospectively designed Phase 3 clinical trial where niraparib demonstrated a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer following a response to platinum-based chemotherapy.

The BRAVO study is assessing niraparib in patients with breast cancer who are germline BRCAmutation carriers. This study is sponsored by TESARO and is being conducted by Breast International Group (BIG) and the European Organisation for Research and Treatment of Cancer (EORTC). Following a recent interim analysis of data by the independent data monitoring committee (IDMC), TESARO believes the BRAVO study is unlikely to produce data that is interpretable and therefore suitable for registration in this indication. A large number of patients in the chemotherapy control arm did not continue in the trial long enough to receive their first radiological scan, which is required to assess disease progression, resulting in an unusually high rate of censoring in the control arm. At this time, TESARO believes this is likely associated with the desire of patients who carry germline BRCA mutations to be treated with a PARP inhibitor rather than chemotherapy and the increased availability of PARP inhibitors. A final determination as to whether the planned enrollment in BRAVO should be completed will be made by the Steering Committee in the near term. No safety concerns have been noted by the IDMC with respect to niraparib. Approximately 5-10% of women with breast cancer are germline BRCA mutation carriers. TESARO expects the results and experience gained from the BRAVO trial to be supportive of the planned trial of niraparib in combination with an anti-PD-1 antibody in women with metastatic triple-negative breast cancer. Approximately 15-20% of women with breast cancer have triple negative breast cancer.

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