{"id":530917,"date":"2017-09-11T18:00:00","date_gmt":"2017-09-11T18:00:00","guid":{"rendered":"https:\/\/www.pm360online.com\/?guid=ce3dedeffe7fb747ef0871bef57ab385"},"modified":"2017-09-11T18:00:00","modified_gmt":"2017-09-11T18:00:00","slug":"onxeo-announces-top-line-results-from-relive-phase-iii-study-of-livatag-in-advanced-hepatocellular-carcinoma","status":"publish","type":"post","link":"https:\/\/www.pm360online.com\/onxeo-announces-top-line-results-from-relive-phase-iii-study-of-livatag-in-advanced-hepatocellular-carcinoma\/","title":{"rendered":"Onxeo Announces Top-Line Results from ReLive Phase III Study of Livatag\u00ae in Advanced Hepatocellular Carcinoma"},"content":{"rendered":"

PARIS, Sept. 11, 2017 (GLOBE NEWSWIRE) — Onxeo S.A. (Euronext Paris:ONXEO) (NASDAQ Copenhagen:ONXEO), (\u201cOnxeo<\/strong>\u201d or the \u201cCompany<\/strong>\u201d), 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\u00ae<\/sup> (doxorubicine Transdrug\u2122) 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.<\/p>\n

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\u00ae<\/sup>, 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\/m\u00b2 and 30mg\/m\u00b2). \u00a0<\/p>\n

The overall safety and tolerability profile of Livatag\u00ae<\/sup> in ReLive was favorable with a fully manageable toxicity profile in both groups of Livatag (20mg\/m\u00b2 and 30mg\/m\u00b2) 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.<\/p>\n

\u201cThe 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.\u00a0 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\u2013 Pugh A), although both drugs cannot be compared due to the lack of assessment of both drugs in the same trial,”<\/em> commented Philippe Merle, MD, Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and Coordinating Investigator of the ReLive study.\u00a0 \u201dWe 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.\u201d <\/em>\u00a0<\/p>\n

The monitoring of the patients still enrolled in the study will continue to completion expected in H1 2019.<\/p>\n

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

\u201cOnce 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,\u201d\u00a0<\/em>said Judith Greciet, Chief Executive Officer of Onxeo. \u201cAs already announced, Onxeo will continue to advance its diversified pipeline of innovative assets in oncology. Refocusing our R&D activities on AsiDNA\u2122 and Beleodaq\u00ae<\/sup> should extend our financial visibility until early 2020.”<\/em><\/p>\n

About Hepatocellular Carcinoma, an aggressive form of primary liver cancer<\/strong><\/p>\n

Hepatocellular carcinoma (HCC) or hepatocarcinoma is the most common of the primary liver cancers (85% to 90%). According to Globocan (2012 data), liver cancer is the 6th most common cancer in terms of incidence (782,000 new cases worldwide each year, 5.6% of all new cancer cases) with the 2nd highest mortality rate (95% lethality) after lung cancer.\u00a0 The major risk factors are infection by hepatitis viruses (B and C), overconsumption of alcohol and metabolic diseases, especially non-alcoholic steatohepatitis (NASH), a growing cause of cirrhosis and HCC.<\/p>\n

About ReLive Phase III trial <\/strong><\/p>\n

This international, multicenter, randomized, comparative Phase 3 trial was conducted in 11 countries (Europe, USA, and MENA) at 70 centers and enrolled 397 adult patients with unresectable hepatocellular carcinoma (HCC), intolerant to sorafenib or having progressed after a systemic therapy including sorafenib. Patients were randomized to receive Livatag\u00ae<\/sup> administered intravenously for 6 hours every 4 weeks (n=263) or best standard of care, i.e. any cancer therapy chosen by the physician except sorafenib (n=134). Treatment was continued until disease progression or unacceptable toxicity. The monitoring of the patients enrolled in the study will continue to completion, expected Q1 2019.<\/p>\n

Upcoming events<\/strong><\/p>\n\n\n\n\n\n\n
September 16, 2017 \u00a0<\/strong><\/strong><\/td>\n11th<\/sup> meeting of the International Liver Cancer Association \u00a0
Oral Presentation of ReLive Results<\/td>\n		Seoul, South Korea<\/td>\n<\/tr>\n
October 2nd, 2017<\/strong><\/td>\nFrench Society of Financial Analysts meeting
ReLive Results & Strategic Update<\/td>\n		Paris, France<\/td>\n<\/tr>\n
October 4-5, 2017<\/strong><\/td>\nLarge & MidCap Forum<\/td>\nParis, France<\/td>\n<\/tr>\n
October 19, 2017<\/strong><\/td>\nPortzamparc Biotech Symposium<\/td>\nParis, France<\/td>\n<\/tr>\n
October 26, 2017 <\/strong><\/td>\nQ3 results and business update<\/td>\n\u00a0<\/td>\n<\/tr>\n<\/table>\n

About Onxeo <\/strong><\/p>\n

Onxeo is a biotechnology company developing innovative drugs for the treatment of orphan diseases in oncology, driven by high therapeutic demand in one of the fastest growing segments of the pharmaceutical industry.<\/p>\n

Onxeo\u2019s objective is to become a major international player in the field of rare or resistant cancers. Its growth strategy is to develop innovative, effective, and safe drugs based on breakthrough technologies that can make a real difference in patients\u2019 lives, by acquiring or in-licensing first-in-class or unique compounds at an early stage and bringing them through translational research and proof of concept clinical development up to value-creating inflexion points. Onxeo\u2019s orphan oncology pipeline comprises products in several on-going preclinical and clinical programs, alone or in combination for various cancer indications.<\/p>\n