Jennifer Litton, MD, discusses the findings from the overall survival analysis of the EMBRACA trial, the implications of these data, and the future utility of talazoparib in this space.
The FDA approved talazoparib in 2018 for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer based on previously published results from the phase 3 EMBRACA trial, which showed that the drug elicited a 3.0-month improvement in the estimated median progression-free survival versus chemotherapy. Notably, the PFS benefit with the agent was observed across all prespecified patient subgroups.
During the 2020 AACR Virtual Annual Meeting I, Litton presented updated findings from the trial, which showed that talazoparib did not demonstrate a statistically significant overall survival benefit compared with chemotherapy in patients with BRCA1/2-mutated metastatic HER2-negative breast cancer.
Although investigators found no statistically significant difference in overall survival between the talazoparib and chemotherapy arms, investigators reported a significant improvement in quality of life with the agent. The PARP inhibitor was associated with a significant delay in the time to definitive clinically meaningful deterioration in quality of life scores, according to Litton.
Moreover, the agent demonstrated favorable tolerability. Approximately 35% of patients who received talazoparib experienced serious adverse events compared with 31% of those who received chemotherapy. However, patients were less likely to discontinue treatment with talazoparib compared with chemotherapy.
In our exclusive interview, Dr. Litton discussed the findings from the overall survival analysis of the EMBRACA trial, the implications of these data, and the future utility of talazoparib in this space.