September 12, 2017
By Alex Keown, BioSpace.com Breaking News Staff
Investors were running away from the company in droves this morning, sending shares to a low of $1.66 this morning.
The company said Livatag (doxorubicine Transdrug) did not differentiate itself statistically from best standard of care in patients with unresectable hepatocellular carcinoma (HCC) who are intolerant to Bayer (BAY)’s chemo drug Nexavar (sorafenib) or have progressed beyond a therapy of sorafenib, the company said. In the trial, Livatag and the control arm showed little difference in efficacy, the company said. Livatag, as single agent, showed a similar effect as the one observed in that comparative group with active treatments.
Onxeo tried to put a positive spin on the trial outcome. The company said the primary reason for the poor trial outcome was the “unexpected high survival” rate in the comparative group. The study was not placebo controlled and patients in the comparative group could receive other anticancer agents (including oxaliplatin, gemcitabine or tyrosine kinase inhibitors). Because those patients could receive the other treatments, Onxeo said that “might explain the high survival rate of the control arm.”
“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,” Philippe Merle, a professor in Hepatology at La Croix Rousse Hospital in France and coordinating trial investigator, said in a statement. ”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.“
Onxeo said patients in the Phase III trial will continue to be monitored through the first half of 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, the company said.
Once that is complete, Onxeo will begin licensing discussions and look for the best path forward, Judith Greciet, Onxeo’s chief executive officer said.
“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,” Greciet said in a statement.
In July, Onxeo said AsiDNA, its DNA repair inhibitor, demonstrated good tolerance, a beneficial safety profile and strong signs of efficacy in a Phase I melanoma trial. The company is looking for it as both a monotherapy and in combination with genotoxic oncology treatments.