Active Biotech (OMX: ACTI) made a nice 5% gain on the heels of the overall survival data from long-term follow-up of the a Phase II study with its quinoline-3-carboxamide linomide analogue tasquinimod in chemotherapy-naive metastatic castrate-resistant prostate cancer presented at the 2012 ASCO Annual Meeting. The intent-to-treat analysis showed median OS of 33.4 vs. 30.4 months and a strong improvement in patients with bone metastases 34.2 vs. 27.1 months.
Given somewhat limited powering (2:1 randomized, 206 patients, double-blind) of the study, and surprisingly prolonged survival of patients on placebo neither number was statistically significant. A multivariate assessment adjustment to address a baseline prognostic factor in favour of the placebo arm shows statistically significant readings in risk of instant death and progression-free survival. A majority of patients on placebo also crossed-over to tasquinimod arm. Active Biotech started a phase 3 study targeting 1200 patients last year. It is expected to report in 2016.
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