Onxeo Announces Top-Line Results from ReLive Phase III Study of Livatag® in Advanced Hepatocellular Carcinoma

Paris (France), September 11, 2017 – 8:00 pm CEST– Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (“Onxeo” or the “Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, today announced top line results from the phase III ReLive trial of Livatag® (doxorubicine Transdrug™) in adult patients with unresectable hepatocellular carcinoma (HCC), intolerant to sorafenib or having progressed after a systemic therapy including sorafenib, when compared to best standard of care. The study did not meet its primary endpoint of improving survival over the comparative group.

The major reason is an unexpected high survival in the comparative group. Indeed, the study was not placebo controlled and patients in the comparative group could receive other anticancer agents (including oxaliplatin, gemcitabine or tyrosine kinase inhibitors) which might explain the high survival rate of the control arm. Livatag®, as single agent, showed a similar effect as the one observed in that comparative group with active treatments. There was no difference in efficacy between the two arms (Livatag 20mg/m² and 30mg/m²).

The overall safety and tolerability profile of Livatag® in ReLive was favorable with a fully manageable toxicity profile in both groups of Livatag (20mg/m² and 30mg/m²) including in those patients who underwent the longest treatment periods, over one year. The overall tolerability was comparable to the one observed in the comparative group.

“The Relive study did not meet its primary endpoint, partly due to the high survival rate in the control arm, which was unprecedented except in the most recent phase III negative trial post Sorafenib in HCC.  However, Livatag tends to show a similar level of efficacy as recently reported for regorafenib in second line, in a well preserved liver function population (Child– Pugh A), although both drugs cannot be compared due to the lack of assessment of both drugs in the same trial." commented Philippe Merle, MD, Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and Coordinating Investigator of the ReLive study.  ”We want to thank all the investigators who have supported the completion of this large phase III trial as well as the patients and their families, and we are confident that they benefited in participating in the Relive study.”

The monitoring of the patients still enrolled in the study will continue to completion expected in H1 2019.

The analysis of predefined subgroups is ongoing and the main results from the ReLive study will be presented on at the upcoming 11th Annual Conference of the International Liver Cancer Association in Seoul, South Korea (ILCA 2017 - ilca2017.org).

“Once the Relive data are fully analyzed, we will reinitiate licensing discussion with potential partners based on key study outcomes to define the best path forward”, said Judith Greciet, Chief Executive Officer of Onxeo. “As already announced, Onxeo will continue to advance its diversified pipeline of innovative assets in oncology. Refocusing our R&D activities on AsiDNA™ and Beleodaq® should extend our financial visibility until early 2020."