The study has demonstrated enhanced PFS in patients treated with talazoparib compared against patients who received physician’s choice standard of care chemotherapy.
Talazoparib is an investigational, oral and dual-mechanism poly ADP ribose polymerase (PARP) inhibitor, which is taken once daily
Embraca is a global, open-label, randomized, parallel and two-arm study of talazoparib against protocol-specific physician’s choice of standard single-agent chemotherapy in gBRCA+ patients who may have received up to three prior cytotoxic chemotherapy regimens for locally advanced and/or metastatic breast cancer.
The company has randomized 431 patients in 2:1 ration to secure talazoparib (1.0mg) once daily or PCT.
Talazoparib also showed improved activity in patients with gBRCA+ MBC in the Phase 2 Abrazo trial, in addition to Embraca.
Currently, talazoparib is being assessed in advanced gBRCA+ breast cancer and other cancer types with deficiencies in DNA damage repair (DDR).
The drug is also being studied in DDR-deficient prostate cancer and in combination with immunotherapy in various tumor types.
Pfizer Oncology global product development chief development officer Mace Rothenberg said: “Results from the EMBRACA study are very encouraging and a great example of precision drug development.
“By enrolling only patients with germline BRCA-positive metastatic breast cancer, treatment with talazoparib reduced the risk of disease worsening by nearly half, compared with current standard of care chemotherapy.”