• Agreement to support expansion of fostroxacitabine bralpamide (fostrox) program with a randomised phase 2b study evaluating fostrox in combination with lenvatinib vs lenvatinib alone in second-line advanced liver cancer (HCC).

• Phase 1b/2a data has demonstrated that the combination of fostrox + lenvatinib has shown to have a manageable safety profile and encouraging anti-tumor activity in second-line population, including a median time to progression (TTP) of 10.9 months [1].

• Medivir’s fostrox is the first oral, liver-targeted treatment in development for advanced liver cancer. Its unique mechanism delivers the cell-killing compound to tumor cells locally in the liver while minimizing harm to healthy cells.

Stockholm, Sweden, 2024 — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, today announced a clinical trial collaboration and supply agreement with Eisai Co., Ltd. (Eisai) to evaluate fostrox in combination with lenvatinib mesylate (product name: Lenvima®, “lenvatinib”) in a randomized, phase 2b study in second-line advanced liver cancer patients (hepatocellular carcinoma/HCC).
 
Under the terms of the agreement, Medivir and Eisai forms a Joint Development Committee, responsible for the planning and implementation of the study. In addition, Eisai will provide a multiple receptor tyrosine kinase inhibitor lenvatinib, a key component of the study, to be used in all study arms. Medivir retains full rights to fostrox. The study will incorporate two dosing levels of fostrox in a dose optimization run-in before selecting recommended dose. Lenvatinib will be dosed as per regulatory approved dosing in advanced liver cancer.

"This clinical trial collaboration and supply agreement with Eisai allows us to build on the encouraging phase 1b/2a data by expanding our fostrox program with a randomized phase 2b study in combination with lenvatinib," said Jens Lindberg, CEO of Medivir. “In our ongoing phase 1b/2a 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.”

“There continues to be an unmet need for patients suffering from Hepatocellular carcinoma (HCC), a major cause of cancer-related deaths,” said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. “The results from the ongoing phase 1b/2a 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 2b study aims to advance a new therapeutic option for patients with HCC.” 
 
Data from the ongoing phase 1b/2a study of fostrox with lenvatinib has been recently presented at ESMO GI in Munich in June and ESMO in Barcelona in September. At these presentations, the combination demonstrated a manageable safety profile and encouraging anti-tumor activity, with a median time to progression of 10.9 months, an Objective Response Rate of 24% and a Disease Control Rate of 81%. Fostrox’ liver targeted and tumor cell specific effect, sparing healthy cells, was confirmed as evidenced by preserved liver function over the duration of treatment. This, together with overall tolerability, contributed to patients staying on treatment much longer than anticipated and experiencing an extended duration of benefit.