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Clinical Trials

Pfizer's breast cancer drug improves progression-free survival in Phase 3 trial

Published 11 December 2017

Pfizer announced that talazoparib has improved progression-free survival (PFS) in patients with germline (inherited) BRCA1/2-positive (gBRCA+) locally advanced or metastatic breast cancer (MBC) in the Phase 3 Embraca study.

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.”