- Talazoparib fails to confer a significant OS benefit over chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer.
Why this matters
- In the primary analysis of EMBRACA trial, talazoparib was associated with significantly improved PFS, but the OS data were immature.
- Final analysis of phase 3 EMBRACA trial: Patients with HER2-negative locally advanced or metastatic breast cancer and germline BRCA mutation were randomly assigned to talazoparib (n=287) or single-agent chemotherapy of physician’s choice (n=144).
- Funding: Pfizer (Medivation).
- The median OS was 19.3 months in the talazoparib arm and 19.5 months in the chemotherapy arm (HR, 0.848, P=.17)
- Survival probability was higher in the talazoparib arm vs the chemotherapy arm at 24, 36, and 48 months.
- Survival outcomes in the talazoparib arm were similar, regardless of subsequent PARP inhibitor or platinum therapy.
- The global health quality of life scores improved in the talazoparib arm but deteriorated in the chemotherapy arm.
- Grade 3/4 serious adverse events in talazoparib and chemotherapy arms were 28.3% and 27%, respectively.
- Open-label design.
Susan Domcheck, MD, of the University of Pennsylvania, said: “Studies investigating approaches to improve survival are incredibly important, because the progression-free survival is not as long as we would like it to be and there’s not an overwhelming overall survival benefit, for sure.”