Pfizer's PARP Inhibitor Talazoparib Approved in China for mCRPC in Combination with Enzalutamide

Nov 05, 2024 15:10 CST Updated 15:10

Pfizer

Pharmaceutical R&D Developer

On November 5, the NMPA website showed that Pfizer's "Talazoparib Tosylate Capsules" was approved for marketing in China.（JXHS2300029/30/31/32)，For use in combination with enzalutamide for the treatment of metastatic castration-resistant prostate cancer。

Image Source: NMPA Official Website

Talazoparib is an orally administered poly ADP ribose polymerase（PARP）Inhibitors not only can suppress the effect of PARP enzymes, causing tumor cells to die due to lack of repair pathways, but also can fix PARP enzymes at DNA damage sites to induce tumor cell death.

In October 2018, Talazoparib was first approved for marketing in the United States for the treatment of patients with harmful or suspected harmful germline BRCA mutations.（gBRCAm）adult patients with HER2-negative locally advanced or metastatic breast cancer. On June 20, 2023, it was also approved by the FDA in combination with enzalutamide.（Enzalutamide）Combined use for metastatic castration-resistant prostate cancer with homologous recombination repair (HRR) gene mutations (mCRPC)Patient.

Notably, TalazoparibIs the first approved to be used in combination with existing standard treatment (Enzalutamide) for homologous recombination repair（HRR）PARP Inhibitors for Adult Patients with Mutant mCRPC。

A Phase III Clinical Trial Evaluating Talazoparib in Combination with Enzalutamide vs. Placebo in Combination with Enzalutamide for the Treatment of mCRPC Showed Results（TALAPRO-2）：Talazoparib Combined with Enzalutamide Reduces Disease Progression or Death Risk by 37% in mCRPC Patients；The radiological progression-free survival of talazoparib combined with enzalutamide（rPFS）Not yet reached, while the rPFS for the placebo plus enzalutamide group was 21.9 months.（HR 0.63；95% CI 0.51-0.78；p<0.0001）。

Image Source: Insight Database

In the subgroup of patients carrying HRR mutations,Talazoparib Combined with EnzalutamideThe risk of disease progression or death in the group was reduced by 54%.（HR，0.46；95% CI，0.30–0.70；P<0.001）, while in the subgroup of patients without HRR mutations,Talazoparib Combined with Enzalutamide GroupThe risk of disease progression or death in the group was reduced by 30%.（HR，0.70；95% CI，0.54–0.89；P=0.004）。

Moreover, the safety profile of the talazoparib and enzalutamide combination therapy is consistent with the known safety information of the two drugs.

PARP inhibitors are the first drugs to achieve success based on the concept of synthetic lethality. Currently, four have been approved in China, respectively.AstraZeneca's Olaparib, BeiGene's Pamiparib, Merck's Niraparib, and Hengrui's Fluazoparib。Pfizer's Talazoparib is the 5th PARP inhibitor approved in China.。

Image Source:Insight Database

According to the Insight database, more than 50 PARP inhibitors globally have entered the clinical trial stage, among which those produced in China include,IMP4297 by InnoPharma（Senaparib，JS109）Already on the market, for the maintenance treatment of patients with stage III-IV epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer who have achieved complete or partial response to first-line platinum-based chemotherapy.（ CXHS2300073/74)，Insight database predicts that it may be approved in Q4 2025.

Image Source:Insight Database

Notably, the target selection for PARP inhibitors under research has become increasingly refined, with companies already developing PARP1 inhibitors (such as AZD-5305, AZD-9574), PARP7 inhibitors (such as JAB-26766), and PRAP14 inhibitors (such as RBN-3143).

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