Pfizer Announces FDA Approval of Talazoparib in Combination with Enzalutamide for HRR Gene-Mutated mCRPC

On June 20, Pfizer announced that the FDA had approved the combination therapy of talazoparib (brand name: Talzenna) and enzalutamide for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) harboring homologous recombination repair (HRR) gene mutations. Talazoparib is the first and only PARP inhibitor to be used in combination with enzalutamide as a first-line treatment for this condition.

Talazoparib, an oral poly ADP-ribose polymerase (PARP) inhibitor acquired by Pfizer in its $14 billion acquisition of Medivation in August 2016, has been shown in studies to inhibit cancer cell growth and promote cancer cell death by inhibiting PARP enzyme activity and trapping PARP at the sites of DNA damage.

In October 2018, Talazoparib was first approved for marketing in the United States for the treatment of adult patients with HER2-negative locally advanced or metastatic breast cancer who carry harmful or suspected harmful germline BRCA mutations (gBRCAm).

The approval and market launch of this new indication are primarily based on the statistically significant and clinically meaningful radiographic progression-free survival (rPFS) data from the Phase III TALA PRO-2 study. In this study, patients were randomly assigned to receive talazoparib or placebo in combination with enzalutamide. The primary endpoint was radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR) according to RECIST 1.1 and PCWG3 criteria, with overall survival (OS) as a key secondary endpoint.

Specific results showed that, compared with placebo + enzalutamide, the combination of talazoparib and enzalutamide reduced the risk of disease progression or death by 55% (HR 0.45; 95% CI, 0.33-0.61; p<0.0001) in patients with mCRPC harboring prospectively identified HRR gene mutations (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C). Data on the key secondary endpoint of overall survival are not yet mature, with the final results expected to be announced in 2024.

In terms of safety, 30% of patients in the talazoparib combination therapy group experienced serious adverse reactions (ARs). Serious adverse reactions reported in over 2% of patients included anemia (9%) and fractures (3%). Additionally, 10% of patients discontinued talazoparib.

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