Pfizer has announced that the phase 3 TALAPRO-2 study of TALZENNA (talazoparib) in combination with XTANDI (enzalutamide) showed a reduction in the risk of disease progression or death in men with metastatic castration-resistant prostate cancer (mCRPC) by 37%.
TALZENNA is an oral poly ADP-ribose polymerase (PARP) inhibitor that blocks PARP enzyme activity and traps PARP where DNA is damaged.
The combination of TALZENNA and XTANDI was significant statistically and clinically meaningful in radiographic progression-free survival (rPFS) in comparison to placebo plus XTANDI in men with mCRPC, with or without homologous recombination repair (HRR) gene mutations.
Pfizer also announced that the US Food and Drug Administration (FDA) granted priority review for its supplemental new drug application (sNDA) for the investigational drug combination for the treatment of mCRPC.
Pfizer global product development oncology and rare disease chief development officer Chris Boshoff said: “Patients with mCRPC need new treatment approaches that can improve outcomes, and the rPFS results from TALAPRO-2, which appears to be the longest observed in a randomised trial in this setting, demonstrate the potential of the TALZENNA and XTANDI combination, if approved, to become a new standard of care.
“We are pleased that the FDA has granted Priority Review for our application, and we look forward to working with the Agency and global regulatory authorities to bring this treatment to men with mCRPC.”
The TALAPRO-2 trial is a two-part, two-cohort, multicentre, randomised, double-blind, placebo-controlled study that recruited 1,106 patients with mCRPC.
The participants were randomised with TALZENNA 0.5mg/day plus XTANDI 160mg/day, or placebo plus XTANDI 160mg/day.
Additionally, the American pharmaceutical company announced the results of a phase 3 clinical trial of zavegepant, which is an investigational calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray intended for the acute treatment of migraine.
The late-stage study met its co-primary endpoints with a single 10mg dose of zavegepant shown to be more effective than placebo for pain freedom as well as freedom from the most bothersome symptom (MBS) two hours after dosing. The trial featured participants who historically had two to eight moderate or severe migraine attacks per month, and their untreated attacks lasted an average of 30.8 hours.
Zavegepant also showed that it alleviated migraine pain in 15 minutes, with many patients reporting that the effect lasted up to 48 hours.
