Active Biotech (NASDAQ OMX NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR:
IPSEY) today presented overall survival (OS) data from the
tasquinimod Phase II study in chemotherapy-naïve metastatic castrate
resistant prostate cancer (CRPC) at the scientific conference "2012 ASCO
Annual Meeting" held in Chicago (USA).
Today at 08:00 am CDT (3:00 pm CET) Dr. Andrew J. Armstrong from the
Duke Cancer Institute (Durham, NC) presented "Tasquinimod and
survival in men with metastatic castration-resistant prostate cancer:
Results of long-term follow-up of a randomized phase II
placebo-controlled trial*" in a poster discussion session.
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).