“Very few patients had to stop treatment altogether in EMBRACA due to the toxicities,” Dr Litton said. “Talazoparib’s biggest adverse event was anemia, which was able to be managed with dose delays, reductions, and transfusions.”
Specifically, grade 3/4 anemia occurred in more than half (55%) of patients assigned to talazoparib and in 38% of patients assigned to chemotherapy. Approximately 6% of patients had adverse events that resulted in discontinuation of talazoparib, and 66% of patients had adverse events that resulted in dose modification.
Patient-reported outcomes from treatment with talazoparib were better than those from participants treated with standard chemotherapy, with patients reporting significant overall improvements in quality of life and significant delays in the time to clinically meaningful deterioration.
Based on these results, “women with BRCA mutations and metastatic breast cancer can consider PARP inhibitor therapy as an active and well-tolerated treatment for breast cancer,” Dr Litton said.
In June, the US Food and Drug Administration granted priority review designation to talazoparib for BRCA-positive breast cancer.3
- Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379:753-763.
- Robson M, Im S-A, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017;377:523-533.
- Pfizer. U.S. FDA and European Medicines Agency accept regulatory submissions for review of talazoparib for metastatic breast cancer patients with an inherited BRCA mutation [press release]. https://press.pfizer.com/press-release/us-fda-and-european-medicines-agency-accept-regulatory-submissions-review-talazoparib-. Published June 7, 2018. Accessed September 19, 2018.