Pfizer announced positive Phase 3 TALAPRO-2 trial results for TALZENNA (talazoparib) combined with XTANDI (enzalutamide) in treating metastatic castration-resistant prostate cancer (mCRPC). The combination therapy showed a statistically significant improvement in overall survival compared to XTANDI plus placebo, regardless of homologous recombination repair (HRR) gene mutation status. The findings were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium.
This news is particularly important for patients with mCRPC, a disease with a historically poor prognosis. The TALAPRO-2 study demonstrates a potential paradigm shift in mCRPC treatment by suggesting a broader application of the combination therapy beyond patients with HRR gene mutations. The observed overall survival benefit, including a nearly 9-month improvement in the unselected cohort and a 14-month improvement in the HRR-mutated cohort, offers new hope for extending survival in this patient population.
The TALAPRO-2 study included two cohorts: one unselected for HRR mutations and another specifically including patients with HRR mutations. In the unselected cohort, the combination therapy resulted in a 20% risk reduction of death, while the HRR-mutated cohort saw a 38% reduction. These findings were consistent across patients with both BRCA and non-BRCA gene alterations. The safety profile remained consistent with the known profiles of each individual drug, with manageable adverse events. Pfizer has shared this data with regulatory authorities, including the FDA and EMA, for potential label updates for TALZENNA.
These positive results position TALZENNA in combination with XTANDI as a potential new standard of care for mCRPC, significantly impacting treatment strategies for a broader range of patients. The observed survival benefit may prompt a reassessment of current treatment guidelines and encourage earlier adoption of this combination therapy, potentially leading to improved outcomes and quality of life for individuals battling this aggressive form of prostate cancer. Further research and regulatory review will be crucial in solidifying the role of this combination in the evolving mCRPC treatment landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
