Global pharma giant Pfizer has reported that its Phase 3 TALAPRO-3 study hit a major milestone, showing that TALZENNA (talazoparib) combined with XTANDI (enzalutamide) significantly delays disease progression in patients with HRR gene-mutated metastatic castration-sensitive prostate cancer (mCSPC).

 

The trial met its primary endpoint, with the combination therapy demonstrating a “statistically significant and clinically meaningful” improvement in radiographic progression-free survival (rPFS) compared with placebo plus XTANDI. The results exceeded the pre-specified target hazard ratio of 0.63, with most patients remaining progression-free at the interim analysis. Benefits were seen across tumors with BRCA and non-BRCA HRR gene alterations.

 

“Current treatment approaches leave many patients with HRR gene-mutated metastatic castration-sensitive prostate cancer vulnerable to early disease progression,” said Neeraj Agarwal, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute at the University of Utah, and global lead investigator for TALAPRO-3. 

 

“The TALAPRO-3 results demonstrate that treatment with TALZENNA in combination with XTANDI earlier in the disease course significantly extends the time patients can live without their cancer worsening.”

 

Interim results also showed a strong trend toward improved overall survival (OS), a key secondary endpoint, along with positive signals in overall response rate, duration of response, and time to PSA progression. Safety data were consistent with the known profiles of both drugs, with no new safety concerns identified.

 

Prostate cancer is the second most common cancer among men worldwide.

 

“Alterations in DNA damage repair genes, such as HRR genes, are found in approximately 25% of metastatic prostate cancers and associated with a worse prognosis and are less responsive to current standards of care, representing a group with a high unmet need,” said Jeff Legos, Chief Oncology Officer, Pfizer. 

 

“TALZENNA plus XTANDI is already a standard of care in HRR gene-mutated metastatic castration-resistant prostate cancer, and these unprecedented results demonstrate the potential to deliver benefit earlier in the disease course. These findings underscore Pfizer’s leadership in precision medicine and commitment to bringing more personalized treatment options to people living with prostate cancer.”