Active Biotech and Ipsen Update the Analysis Plan for the 10TASQ10 Trial Evaluating Tasquinimod in the Treatment of Prostate Cancer
Regulatory News:
Active Biotech (NASDAQ OMX NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) (Paris:IPN) today announced that the companies have updated the analysis plan for the 10TASQ10 trial, a global Phase III clinical trial evaluating tasquinimod in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have not yet received chemotherapy.
The companies now plan to conduct the primary PFS analysis for the 10TASQ10 trial in 2014, at the same time as the first interim overall survival (OS) analysis. The time point for the OS interim analysis will be driven by the number of OS events. The specified number of radiographic progression-free survival (PFS) events for the primary end-point will have been exceeded at the time of interim OS analysis.
Dr. Claude Bertrand, Executive Vice president R&D, Chief Scientific Officer at Ipsen, stated: "Based on the new regulatory and medical environment in the field of prostate cancer, we have reviewed the analysis strategy for the 10TASQ10 trial. We now plan to conduct the 10TASQ10 primary PFS analysis in 2014 when more mature data on OS will be available."
"The strategy to use interim OS analysis is a very logical way to secure both PFS and OS data", said Michael Carducci, Professor of Oncology and Urology at the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University and Principal Investigator for the 10 TASQ10 clinical trial.
Professor Tomas Leanderson, President & CEO Active Biotech stated: "To harness both PFS and OS data while the study is still blinded secures that this analysis plan provides us with the most robust data set in order to progress the development of the TASQ project."
The randomized, double-blind, placebo-controlled, Phase III 10TASQ10 trial met its enrollment target in December 2012 with 1,245 randomized patients as planned in the clinical protocol. The aim of the study is to confirm tasquinimod´s efficacy, with radiological Progression Free Survival (PFS) as primary endpoint and overall survival (OS) as key secondary endpoint. The study recruited patients in 37 countries covering more than 200 centers.
About tasquinimod
Tasquinimod is a novel small molecule that targets the tumor microenvironment by binding to S100A9 and modulating regulatory myeloid cell functions, exerting immunomodulatory, anti-angiogenic and anti-metastatic properties. Tasqunimod may also suppress the tumor hypoxic response, contributing to its effect on the tumor microenvironment. Today the development of tasquinimod is principally focused on the treatment of prostate cancer.
It was announced in December 2009 that the primary endpoint of the Phase II clinical study, to show a higher fraction of patients with no disease progression during the six-month period of treatment using tasquinimod, had been met. Phase II results were published in Journal of Clinical Oncology in September 2011. The results showed that 6 month progression-free proportions for TASQ and placebo groups were 69% and 37%, respectively (p