Onxeo announces 6th positive DSMB recommendation for Livatag® ReLive study in HCC
Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced that the independent European board of experts, the Data Safety Monitoring Board (“DSMB”), which monitors the safety of the Livatag® phase III trial, “ReLive”, has once again unanimously recommended to continue the study without modification.
ReLive is an international, randomized phase III trial aiming at demonstrating the efficacy of Livatag® on survival in 400 patients with advanced hepatocellular carcinoma (HCC) (primary liver cancer) after failure of intolerance to Sorafenib.
The DSMB meets every 6 months to review the safety data of the ReLive trial and consequently issues recommendations on the conduct of the study.
More than 40% of the patients have been randomized already in the study and the DSMB reviewed the data for slightly less patients (approximatively 35% of the patients) totaling about 350 infusions of Livatag®.
For the 6th time since study initiation, the group unanimously recommended to continue the study without modification, based on its positive assessment of the safety data of Livatag® .
“Our confidence in Livatag®’s safety profile has so far proven to be correct. The positive recommendation from our independent board of experts, the DSMB, based on substantial number of patients and infusions now, truly reinforces this confidence, and we recognize this 6th recommendation as an emphasis of Livatag®’s potential to aid liver cancer patients, a very severe disease for which the medical need is extremely high”, comments Judith Greciet, CEO of Onxeo.