Resistant prostate cancer: a new drug in Europe

Pfizer announced approval European Commission (EC) Talzenna (talazoparib), an oral polyADP ribose polymerase (PARP) inhibitor, in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRP), in which chemotherapy This is not clinically indicated.

With this approval, talazoparib became the first and only PARP inhibitor approved in European Union for use with enzalutamide in patients with mCRPC with or without genetic mutations.

“The European Commission’s approval of talazoparib in combination with enzalutamide represents an important step forward in the treatment of patients with metastatic castration-resistant prostate cancer. more advanced and aggressive phase illness.”

“And this approval covers an area where we needed new treatment options, thereby increasing the proportion of patients who could benefit from a drug that could keep the disease under control for longer,” he explains. Joan CarlesOncologist, Head of Department and Head of the Department of the Genitourinary System, Central Nervous System, Sarcoma and Tumors of Unknown Origin, Val d’Hebron Hospital and co-author of the study Clinical study TALAPRO-2.

Improving survival from prostate cancer

Approval is based on results Phase 3 clinical trial TALAPRO-2, a multicenter, randomized, double-blind, placebo-controlled trial, included two groups of patients with mCRPC: a group consisting of all unselected patients (n=805), and group 2 consisting of patients with mutations in the HRR genes (HRRm; n =399).

Results from TALAPRO-2 Cohort 1 published in a scientific journal Lancetshowed that treatment with Talzenna plus enzalutamide reduced the risk of radiological progression or death by 37 percent compared with placebo plus enzalutamide (HR, 0.63; 95 percent CI, 0.51 to 0.78; P < 0. 0001), achieving the main goal of the study. improving radiographic progression-free survival (rPFS).

At the time of analysis, median rPFS had not yet been reached in patients receiving talazoparib plus enzalutamide, compared with 21.9 months in patients receiving placebo plus enzalutamide. A positive trend was also observed in overall survival (OS), a key secondary endpoint, in favor of Talzenna plus enzalutamide, although this data is not yet ready. The safety of talazoparib plus enzalutamide in the TALAPRO-2 clinical trial was consistent with Known safety profile of each drug.

“After years of battling prostate cancer, it can be devastating for a patient to discover that their cancer has stopped responding to treatment that reduces testosterone level. At this stage of the disease, the prognosis is usually poor, so patients urgently need new treatment options,” he explained. José Chavez, Medical Director of Pfizer Spain.

Prostate cancer in Spain

Metastatic castration-resistant prostate cancer (mCRPC) is cancer that has spread beyond the prostate gland and progresses despite drug or surgical treatment to lower testosterone levels.

In 2023 In Spain, it is estimated that prostate cancer will reach a total of approximately 29,002 new cases. It is the most common cancer in men, accounting for 10.4 percent of all cancers in both sexes and 18.2 percent of all cancers. cancer in men.