Tasquinimod improved radiographic progression-free survival (rPFS) in contrast with placebo in chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC), a study published in the Journal of Clinical Oncology has shown.1
Researchers enrolled 1245 chemotherapy-naïve patients from 37 countries with mCRPC and evidence of bone metastases. Median patient age was 71, 77.3% had a Karnofsky performance status of at least 90%, and 21.1% had visceral metastases. Participants were randomly assigned 2:1 to receive either tasquinimod or placebo.
Results showed that estimated median rPFS by central review was 7.0 months (95% CI, 5.8-8.2) with tasquinimod, versus 4.4 months (95% CI, 3.5-5.5) with placebo (hazard ratio, 0.64; 95% CI, 0.54-0.75; P < .001).
Median overall survival was 21.3 months (95% CI, 19.5-23.0) and 24.0 months (95% CI, 21.4-26.9), for tasquinimod and placebo, respectively (hazard ratio, 1.10; 95% CI, 0.94-1.28; P = .25).
Patients in the tasquinimod arm reported grade 3 or worse adverse events more frequently than those in the placebo group (42.8% versus 33.6%), respectively. The most common grade 3 or worse tasquinimod-related adverse events were anemia, fatigue, and cancer pain.
1. Sternberg C, Armstrong A, Pili R, Ng S, Huddart R, Agarwal N, et al. Randomized, double-blind, placebo-controlled phase III study of tasquinimod in men with metastatic castration-resistant prostate cancer [published online ahead of print June 13, 2016]. J Clin Oncol. doi: 10.1200/JCO.2016.66.9697.