Phase 2 Study Update of Tasquinimod for Metastatic Castrate-Resistant Prostate Cancer
Active Biotech and Ipsen announced positive overall survival improvement data from the Phase 2 study of tasquinimod for chemotherapy-naïve patients with metastatic castrate resistant prostate cancer (CRPC).
This study was a Phase 2, randomized, double-blind, placebo-controlled trial investigating up to 1mg/day of tasquinimod vs. placebo in 206 asymptomatic patients with metastatic castrate resistant prostate cancer (CRPC). The primary endpoint, patients with disease progression at six months, was reached. Analyses showed median overall survival times (OS) of 33.4 vs. 30.4 months (p=0.49, HR 0.87, 95% CI 0.59–1.29) in favor of tasquinimod. A stronger trend for survival benefit is observed in patients with bone metastases; median OS was 34.2 vs. 27.1 months (p=0.19, HR 0.73, 95% CI 0.46–1.17). A multivariate analysis of known CRPC prognostic factors demonstrated statistically significant OS advantage for tasquinimod treated patients (p=0.034, HR=0.64, 95% CI 0.42–0.97).
Tasquinimod is a linomide analogue with a pleiotropic mode of action which includes immunomodulatory, anti-angiogenic and anti-metastatic activity.