On April 16, 2015 Active Biotech and Ipsen reported top line results of the 10TASQ10 study (Press release, Ipsen, APR 16, 2015, View Source [SID:1234503022]). While the study showed that tasquinimod reduced the risk of radiographic cancer progression or death compared to placebo (rPFS, HR=0.69, CI 95%: 0.60 – 0.80) in patients with metastatic castration resistant prostate cancer (mCRPC) who have not received chemotherapy, tasquinimod did not extend overall survival (OS, HR=1.09, CI 95%: 0.94 – 1.28). Schedule your 30 min Free 1stOncology Demo! Efficacy results together with preliminary safety data do not support positive benefit risk balance in this population. Therefore the companies have decided to discontinue all studies in prostate cancer. Full results will be presented at an upcoming scientific conference.
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Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated: "We are disappointed for prostate cancer patients. Ipsen remains strongly committed to oncology. We are grateful to the clinicians, caregivers, patients and their families who were involved in this study."
Professor Tomas Leanderson, President and Chief Executive Officer of Active Biotech stated:
"The outcome of the 10TASQ10 study is a major disappointment based on the promising phase II results. However, the data at hand is unambiguous and cannot motivate further development of tasquinimod in this patient population. I want to thank the clinicians, caregivers, patients and their families who were involved in this study."
Ipsen and Active Biotech are in communication with trial investigators, ethics committees and the relevant regulatory authorities, to provide them with updated and current information in compliance with local regulations. The companies are working with trial investigators and local regulatory authorities to ensure that patients who participated in the tasquinimod trials are transitioned to appropriate therapies so that trial participants receive appropriate care.
About tasquinimod
Tasquinimod is a novel oral immunotherapy that targets the tumor microenvironment by binding to S100A9 and modulating regulatory myeloid cell functions, exerting immunomodulatory, anti-angiogenic and anti-metastatic properties. Today the development of tasquinimod principally has been focused on the treatment of prostate cancer, but early clinical studies in other cancer indications are performed.
About the 10TASQ10 trial
The 10TASQ10 trial is a randomized, double-blind, placebo-controlled, global Phase III clinical trial evaluating tasquinimod in patients with metastatic castration resistant prostate cancer (mCRPC) who have not yet received chemotherapy. The aim of the 10TASQ10 study is to confirm tasquinimod’s efficacy, with radiological Progression Free Survival (rPFS) as primary endpoint and overall survival (OS) as key secondary endpoint. The Phase III 10TASQ10 trial met its enrollment target in December 2012 with more than 1,200 randomized patients as planned in the clinical protocol.