HealthDay News — For chemotherapy-naive men with metastatic castration-resistant prostate cancer (mCRPC), tasquinimod is associated with improved radiographic progression-free survival (rPFS), according to a phase III study published online in the Journal of Clinical Oncology.
Cora Sternberg, MD, from the San Camillo Forlanini Hospital in Rome, and colleagues conducted a phase III trial involving men with chemotherapy-naive mCRPC and evidence of bone metastases. A total of 1,245 patients were randomized to tasquinimod once per day (832 men) or placebo (413 men) at 241 sites in 37 countries. The primary end point was rPFS per Prostate Cancer Working Group 2 criteria and RECIST 1.1.
The researchers found that the estimated median rPFS by central review was 7 and 4.4 months with tasquinimod and placebo, respectively (hazard ratio, 0.64; 95% confidence interval, 0.54 to 0.75; P < .001). The median overall survival (OS) was 21.3 and 24 months with tasquinimod and placebo, respectively (hazard ratio, 1.10; 95% confidence interval, 0.94 to 1.28; P = .25). More frequent grade ≥3 adverse events were seen with tasquinimod (42.8% versus 33.6%), most commonly anemia, fatigue, and cancer pain.
“In chemotherapy-naive men with mCRPC, tasquinimod significantly improved rPFS compared with placebo,” the authors write. “However, no OS benefit was observed.”
Several authors disclosed financial ties to the biopharmaceutical industry; the study was funded by Active Biotech, the manufacturer of tasquinimod.
- Sternberg C, Armstrong A, Pili R, et al. Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2016; doi: 10.1200/jco.2016.66.9697.