Pfizer’s prostate cancer therapy Talzenna, when combined with Xtandi, can extend overall survival (OS) by nearly nine months over the standard of care (SoC), according to a Phase III trial.
The US biopharma has announced results from its Talapro-2 trial (NCT03395197) that sought to examine its oral poly ADP-ribose polymerase (PARP) inhibitor, Talzenna (talazoparib), alongside androgen receptor pathway inhibitor (ARPI) Xtandi (enzalutamide).
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The study examined metastatic castration-resistant prostate cancer (mCRPC) patients, with or without homologous recombination repair (HRR) gene mutations. Patients were split into two cohorts split between patients selected, or not, for HRR gene mutations.
In the group without selected mutations, the Talzenna and Xtandi arm saw a median OS of 45.8 months compared with 37 months in the arm treated with Xtandi and placebo. In the group of selected patients with HRR-mutated mCRPC, the combination therapy saw OS of 45.1 months against the placebo arm’s 31.1 months, equating to a 38% reduction in the risk of death and a 14-month gain over the SoC.
The trial specifically recruited 1,035 unique patients with mCRPC who had not received new life-prolonging systemic treatments, across 184 international sites.
Pfizer’s chief oncology officer Roger Dansey said: “Since its approval, Talzenna in combination with Xtandi has redefined the standard of care for those living with homologous recombination repair gene-mutated mCRPC.
“This latest data from Talapro-2 is extremely compelling, demonstrating that the combination significantly extended overall survival, in patients selected and unselected for HRR gene alterations, potentially shifting the treatment paradigm for all men living with mCRPC.
“Although definitive conclusions cannot be drawn across studies, these results appear to represent the longest median OS reported in a randomised, controlled Phase III trial in mCRPC.”
Research by GlobalData found that Talzenna brought in $138m in sales for Pfizer in 2024 and is estimated to generate $929m by the end of 2030. Xtandi brought in $7.9bn last year, yet sales are expected to drop to $1.7bn by the end of the decade.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of prostate cancer care, Exact Sciences has shared results from a trial of its Oncodetect test, which is designed to identify the last remaining cells post-cancer treatment. Meanwhile, Israeli pharmaceutical company RedHill Biopharma has initiated a placebo-controlled Phase II trial to examine its combination of opaganib and darolutamide.
