Yahoo Finance Pfizer (PFE) Begins Dosing in Prostate Cancer Drugs Study
Pfizer Inc. PFE announced that it has dosed the first patient in a phase III study — TALAPRO-3 — that will evaluate a combination regimen of its oral PARP-inhibitor, talazoparib, and androgen receptor inhibitor drug, Xtandi, as a potential new treatment for prostate cancer.
The TALAPRO-3 study will evaluate 0.5mg of talazoparib in combination with 160mg of its prostate cancer drug, Xtandi, as a potential treatment for DNA damage response (DDR)-deficient metastatic castration-sensitive prostate cancer (mCSPC). The study will evaluate a lower dose (0.35mg) of talazoparib in patients with moderate renal impairment. The study will enroll 550 patients across different countries with top-line data anticipated in late 2024. The primary endpoint of the study is radiographic progression-free survival, with overall survival as the secondary endpoint.
Please note that talazoparib is already approved as Talzenna for treating adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Xtandi is approved to treat castration-resistant prostate cancer (CRPC) and CSPC.
The company is also developing Talzenna in combination with Xtandi in another phase III study — TALAPRO-2 —for treating metastatic CRPC, with and without DDR defects.
Shares of Pfizer have increased 6.1% year to date compared with the industry’s growth of 6.8%.
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We note that the PAPR inhibitor segment is led by AstraZeneca’s AZN Lynparza. The drug is approved for treating multiple indications, namely ovarian, breast, prostate and pancreatic cancer in different treatment settings. Other FDA-approved PARP inhibitors include Glaxo’s GSK Zejula and Clovis Oncology’s CLVS Rubraca. While Zejula is only approved for treating ovarian cancer, Rubraca is approved for patients with ovarian or prostate cancer.
However, there is significant growth opportunity in the PARP inhibitor segment with very few competitors. Moreover, sales of Lynparza, Zejula and Rubraca have shown robust growth in the past couple of years. Per a report from a market research company in India, Coherent Market Insights, the PARP inhibitor market is projected to grow at a CAGR of 32.4% during the period 2019 to 2027, and cross $8.8 billion in 2027. Although Pfizer’s Talzenna is a new entrant in this segment with its approval for breast cancer in 2018, it is well poised to capitalize on the strong growth potential of the overall PARP inhibitor segment.
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