Onxeo S.A., an innovative company specializing in the development of orphan oncology drugs, today announced that 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® Phase III trial, “ReLive”, to continue the study without modification. This marks the seventh positive DSMB recommendation and further confirms the acceptable safety profile of Livatag.
ReLive is an ongoing international, randomized Phase III trial designed to evaluate the efficacy of Livatag® in patients with advanced hepatocellular carcinoma (HCC) (primary liver cancer) after failure or intolerance to sorafenib. The study, which plans to enroll a total of 400 patients, compares intravenous administration of Livatag® to the best standard of care.
The DSMB meets regularly, twice a year, to review the safety data of the ReLive trial and subsequently issues recommendations on the conduct of the study.
To date, more than 50% of the patients have been randomized in the study. The DSMB has reviewed the safety data from these patients, totaling more than 500 infusions of Livatag® in the trial and for the seventh time since study initiation, has unanimously recommended to continue the study without modification, based on its positive assessment of the safety data of Livatag®.
“This latest positive recommendation from our independent board of experts confirms once again Livatag®’s acceptable safety profile, based on safety data collected on a substantial number of patients. These data certainly strengthen our confidence in the potential of this product, which represents a potential significant breakthrough in the treatment of hepatocellular carcinoma, a very severe cancer with a high unmet medical need,” commented Judith Greciet, CEO of Onxeo.