Medivir signs new clinical trial collaboration with Eisai
Medivir has entered into a clinical trial collaboration and supply agreement with Eisai to evaluate its liver-targeted treatment, fostrox, in combination with lenvatinib for advanced liver cancer. This partnership allows Medivir to build on the promising results from the ongoing phase Ib/IIa study by advancing to a randomized phase IIb study.
Primary liver cancer, with hepatocellular carcinoma (HCC) being its most prevalent type, is the third leading cause of cancer-related fatalities globally. Despite the availability of treatments that can prolong the lives of patients with HCC, not all patients respond to these therapies, which results in persistently high mortality rates.
Medivir’s fostrox aims to become the first approved second-line therapy for HCC. It offers a targeted approach that limits damage to healthy liver cells by delivering its cytotoxic agent directly to tumor sites.
Promising phase Ib/IIa data in HCC
Currently, fostrox is in the final stage of an ongoing phase Ib/IIa study in combination with Eisai’s lenvatinib mesylate (Lenvima). While Tecentriq/Avastin is the recommended first-line treatment, options are limited when patients progress to second-line treatment.
Phase Ib/IIa data has shown that fostrox and lenvatinib is well tolerated with promising anti-tumor activity. Results presented at ESMO in September indicated efficacy that is better than what can be expected with Lenvima alone with a median time to progression of 10.9 months, an Objective Response Rate of 24 per cent, and a Disease Control Rate of 81 per cent. Additionally, the tolerability of the combination has allowed patients to remain on treatment longer, leading to prolonged benefits.
Extended clinical collaboration with Eisai
In the new collaboration, Medivir and Eisai will conduct a randomized phase IIb study comparing fostrox plus lenvatinib to lenvatinib monotherapy as a second-line treatment for HCC. Eisai will provide lenvatinib for the study, while Medivir retains full rights to fostrox. A Joint Development Committee will oversee the study’s design and execution, beginning with a dose optimization phase to determine the ideal fostrox dosage before proceeding to broader testing.
In a press release, Jens Lindberg, CEO of Medivir said:
“In our ongoing phase Ib/IIa study, fostrox + lenvatinib has shown to have a manageable safety profile and encouraging anti-tumor activity for second-line liver cancer patients. Fostrox + lenvatinib has the potential to become the first, approved treatment option after first-line treatment with immunotherapy combination, a population with an estimated market value in excess of $2.5bn by 2030.”
Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai also commented on the collaboration:
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.“There continues to be an unmet need for patients suffering from Hepatocellular carcinoma (HCC), a major cause of cancer-related deaths. The results from the ongoing phase Ib/IIa study with the combination of fostrox and lenvatinib in second-line advanced liver cancer are encouraging. Our collaboration with Medivir for the upcoming randomized phase IIb study aims to advance a new therapeutic option for patients with HCC.”
