Onxeo gets DSMB go-ahead to continue Livatag study

France-based orphan oncology drugs firm Onxeo (Euronext Paris: ONXEO) says it has received a unanimous recommendation from the Data Safety Monitoring Board (DSMB), the independent European board of experts that monitors the safety of the Livatag (doxorubicin Transdrug) Phase III trial, “ReLive” to continue the study without modification.

As per study protocol, the DSMB meets twice a year to review the safety data of the ReLive trial and subsequently issues recommendations on the conduct of the study. Onxeo’s shares rose 5.7% to 3.33 euros on the news. The positive DSMB recommendation granted for the eighth time further confirms the acceptable safety profile of Livatag.

ReLive is an ongoing international, randomized Phase III trial designed to evaluate the efficacy of intravenous (IV) administration of Livatag in patients with advanced hepatocellular carcinoma (HCC, primary liver cancer) after failure or intolerance to sorafenib. The study plans to enroll a total of 400 patients across approximately 90 sites. To date, more than 65% of the patients have been randomized in the study.