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Onxeo’s liver cancer drug Livatag fails in phase 3 trial

PBR Staff Writer Published 13 September 2017

French biotechnology company Onxeo has announced that its liver cancer drug Livatag (doxorubicine Transdrug) failed to meet the primary endpoint in a phase 3 trial in adult patients with unresectable hepatocellular carcinoma (HCC).

Livatag could not improve survival of the HCC patients when compared to best standard of care according to the findings of the phase 3 trial dubbed as ReLive.

The late-stage trial featured HCC patients who were either intolerant to sorafenib or whose disease had progressed following a systemic therapy including sorafenib.

Onxeo attributed the failure of the phase 3 liver cancer study of Livatag mainly to the unexpected high survival in the comparative arm.

It added that the phase 3 ReLive trial was not placebo controlled while the patients in the comparative group could be administered with other anticancer agents like oxaliplatin, tyrosine or gemcitabine kinase inhibitors which could be reason behind their high survival rate.

However, Onxeo stated that as single agent, Livatag had demonstrated identical effect as the one noted down in the comparative patient arm with active treatments.

It also said there was no efficacy difference between the Livatag arm and the comparative group.

According to Onxeo, Livatag showed a favorable safety and tolerability profile in ReLive with a fully manageable toxicity profile in patients who were subjected to strengths of either 20mg/m² or 30mg/m².

Onxeo CEO Judith Greciet said: “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.

“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.”

Onxeo plans to continue monitoring the still enrolled patients in the trial until its completion in the first half of 2019.


Image: Onxeo’s Livatag could not meet primary endpoint in ReLive trial. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.