An experimental PARP medication acquired from Pfizer’s multibillion-dollar Medivation buyout performed positively in a late-stage trial as the Big Pharma is now looking at regulatory filings. The star for the $14 billion deal was Medivation’s cancer drug Xtandi, but its pipeline and now one of those later candidates from its pipeline is looking promising.
Talazoparib, is an oral, once-a-day PARP inhibitor being examined in the EMBRACA study in a specific set of patients, namely those with germline (inherited) BRCA1/2-positive (gBRCA+) locally advanced and/or metastatic breast cancer (MBC). PARP became popular in 2016, as positive data, as well as a series of approvals, partially outperformed other I-O and gene editing technology for column inches. The data indicated greater progression-free survival (PFS) in patients treated with the drug compared to patients that received chemotherapy. Median PFS was 8.6 months for patients on talazoparib, while patients on chemo was 5.6 months.
“This represents a 46% reduction in the risk of disease progression,” Pfizer said in a statement adding that it will now “be discussing these data from EMBRACA […] with worldwide health authorities”.
Pfizer is optimistic for the chance for its candidate to enter the market to compete with AstraZeneca’s Lynparza, Tesaro Zejula and Clovis’ Rubraca.
Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development, stated: “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. This includes heavily pretreated patients, those with hormone receptor-positive disease and those who had a history of brain metastases.”
PARP has not proven successful in other studies yet. AbbVie recently reported that its PARP inhibitor, veliparib, failed in two late-stage trials in non-small cell lung cancer and triple negative breast cancer.