- Massachusetts-based Tesaro said Wednesday its cancer drug met its primary goal in a Phase 3 trial of 500 patients with ovarian cancer, sending shares of the company soaring in early trading.
- Among patients with germline BRCA mutation, niraparib extended progression-free survival (PFS) times by 16 months, compared to a placebo. The effect was less stark, but still significant, for patients without the mutation.
- Tesaro plans to release full results of the trial at the European Society for Medical Oncology meeting in October, and expects to submit niraparib for U.S. approval in the fourth quarter of this year.
Tesaro stock doubled in value Wednesday morning, as news of the positive phase 3 data raised hopes niraparib could become a significant new treatment for ovarian cancer.
“New treatment options are needed to extend the time in between cycles of platinum-based chemotherapy for these patients, and the results from the NOVA study suggest that niraparib could represent an important new treatment option for many patients with ovarian cancer," said Tom Herzog, clinical director at the University of Cincinnati Cancer Institute.
Among ovarian cancer patients with the BRCA mutation, treatment with niraparib resulted in a median progression-free survival (PFS) of 21 months, compared to 5.5 months for patients in the control arm.
Tesaro designed the Phase 3 trial to also test niraparib in patients without that specific mutation.
For patients who weren't BRCA mutation carriers but have homologous recombination deficit tumors, median PFS was 12.9 months for patients taking niraparib. This still compared favorably to the control group, which had a median PFS of 3.9 months.
While Tesaro noted adverse effects to treatment with niraparib could generally be managed through dose modifications, 14.7% of patients discontinued treatment with niraparib. The most common grade 3 or 4 adverse effects were thrombocytopenia, anemia, and neutropenia.
Tesaro is also testing niraparib in another Phase 3 trial of patients with BRCA-positive breast cancer, as well as a Phase 3 trial for patients with first-line ovarian cancer. Janssen Biotech has licensed rights to niraparib specifically for development against prostate cancer.