• FDA clearance of Investigational New Drug (IND) application to evaluate fostrox (fostroxacitabine bralpamide) in combination with Lenvima® vs Lenvima alone in a randomized phase 2b study in second-line advanced liver cancer (hepatocellular carcinoma, HCC).
• Phase 1b/2a data has demonstrated that the combination of fostrox + Lenvima has shown 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 plans to recruit patients in at least 8 countries across USA, Europe and Asia, aiming for study read-out in 2027.

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, today announced the approval of the US Investigational New Drug application (IND) for evaluating fostrox + Lenvima vs Lenvima alone in a phase 2b study in 2nd line advanced HCC.
 
"Opening of the IND for fostrox in combination with Lenvima in a randomized phase 2 study, is a significant milestone in Medivir’s mission to improve life for patients with advanced liver cancer. Our recently closed phase 1b/2a study has shown a manageable safety profile and promise of anti-tumor activity beyond current second-line alternatives in advanced HCC. Through this phase 2b study, we aim to make the fostrox + Lenvima combination the first, approved second line treatment option after immunotherapy.” says Dr. Pia Baumann, CMO at Medivir.
 
The randomized phase 2b study will evaluate the combination of fostrox + Lenvima vs Lenvima alone in second-line advanced HCC patients who have previously been treated with an immunotherapy combination. The primary endpoint is Objective Response Rate with secondary endpoints including duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety and Quality of Life. Principal Investigator of the study is Prof. Maria Reig, Director of the Barcelona Clinic Liver Cancer (BCLC) and the Liver Oncology Unit at the Hospital Clinic of Barcelona in Spain, and one of the most renowned global experts in the field of liver cancer.
 
"There is a significant unmet medical need for patients suffering from liver cancer, especially in second-line advanced liver cancer, where there are no approved treatment options available after an immunotherapy combination,” said Prof. Maria Reig from BCLC, Hospital Clinic Barcelona. “Preserved liver function is of vital importance in this patient population, why treatments not only need to be effective but also “liver” tolerable, meaning no negative impact on liver function. The data has shown that fostrox + Lenvima have encouraging results related to clinical outcome in patients with second-line advanced HCC without jeopardizing safety, including liver function. The planned phase 2b study, evaluating fostrox added to Lenvima in a randomized, controlled trial, is an important study, in our ongoing efforts to improve treatment options for patients in second-line”.