Ipsen, Active Biotech present OS data from tasquinimod Phase II study on CRPC at ASCO 2012

The intention-to-treat analysis 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, ITT) in favor of tasquinimod, longer than previously reported in this metastatic prostate cancer population. 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). This phase II clinical trial was designed to test the safety and efficacy of tasquinimod. Noteworthy, 41 (61%) patients crossed-over from placebo to tasquinimod (mean time to cross-over approx. 5 months). Also, there were imbalances in baseline prognostic factor in favor of the placebo arm. These were addressed with a multivariate analysis of known CRPC prognostic factors. It demonstrated a statistically significant OS advantage for tasquinimod treated patients with a hazard ratio (HR) of 0.64 (95% CI 0.42-0.97, p=0.034), a decrease of approximately 40% in the instantaneous risk of event (death), accompanied by improvement in progression-free survival (HR 0.52, 95% CI 0.35-0.78, p=0.001).   

"Men with metastatic CRPC in this trial were unexpectedly found to have prolonged survival times beyond that previously reported in this patient population, despite a high fraction of patients with liver and lung metastases," says principal author Andrew Armstrong, MD ScM, Assistant Professor of Medicine and Surgery at Duke University and the Duke Prostate Center. "We also found that despite initial imbalances in baseline characteristics, the improvements in progression-free survival with tasquinimod may translate into improvements in overall survival, and, if confirmed in the ongoing phase 3 trial, suggests that tasquinimod may have an important role in the future treatment of men with CRPC."

Tomas Leanderson, President and CEO of Active Biotech, said: "These data further increase our strong confidence in tasquinimod as a valuable asset to address the huge medical need for hundreds of thousands of men with limited treatment options today."

Claude Bertrand, Executive Vice-President R&D, Chief Scientific Officer of Ipsen said: "We are thrilled with Tasquinimod's phase II results as they underline the activity of the compound. With its differentiated mechanism of action, we look forward to completing the ongoing phase III and replicating these interesting results to propose an alternative treatment that does not target the androgen receptor pathway to progressing patients."