Medivir receives IND approval for oral liver cancer drug Fostrox

Medivir AB, a pharmaceutical company based in Stockholm, Sweden, recently received approval from the US Food and Drug Administration (FDA) for an Investigational New Drug (IND) application. This approval will allow the company to proceed with a phase 2b study to evaluate the combination of fostroxacitabine bralpamide (fostrox) and Lenvima® in comparison to Lenvima alone. This study targets patients with second-line advanced liver cancer, specifically hepatocellular carcinoma (HCC). The planned study is a significant step in Medivir's efforts to provide improved treatment options for patients facing this challenging condition.

The endeavor follows promising results from a prior phase 1b/2a study, which demonstrated that combining fostrox with Lenvima has a manageable safety profile and encouraging anti-tumor activity. Notably, this combination exhibited a median time to progression of 10.9 months for patients, establishing a potential new avenue in the treatment of advanced liver cancer. Medivir intends to recruit participants from at least eight countries across the USA, Europe, and Asia, with the goal of completing the study by 2027.

Dr. Pia Baumann, Chief Medical Officer at Medivir, emphasized the importance of the study, describing the IND approval as a significant milestone in their mission to enhance the lives of patients with advanced liver cancer. This phase 2b study aims to establish the fostrox and Lenvima combination as the first approved second-line treatment option post-immunotherapy for advanced HCC.

The study's primary focus will be on evaluating the Objective Response Rate (ORR) of the treatment combination. Secondary objectives include assessing the duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety, and the impact on Quality of Life for the patients. The trial will involve patients who have previously undergone treatment with an immunotherapy combination, a population for whom there are currently no approved second-line treatment options.

The study's Principal Investigator, Professor Maria Reig, is a leading expert in liver cancer and serves as the Director of the Barcelona Clinic Liver Cancer (BCLC) and the Liver Oncology Unit at the Hospital Clinic of Barcelona, Spain. Professor Reig highlighted the significant unmet medical needs of liver cancer patients, particularly those in the second-line advanced category. She pointed out the critical importance of preserving liver function in these patients, emphasizing that any effective treatment must also be liver-tolerant to avoid adversely affecting liver health.

Professor Reig expressed optimism regarding the combination of fostrox and Lenvima, noting that it has shown promising clinical outcomes without compromising patient safety or liver function. The forthcoming phase 2b study is viewed as an essential step in ongoing efforts to expand and improve treatment options for patients who have exhausted current second-line therapies.

This research signifies a crucial development in the treatment of advanced HCC, a field with few existing options, particularly following immunotherapy. Medivir's commitment to advancing this combination therapy could potentially offer a new lifeline to patients battling this aggressive form of liver cancer, emphasizing the company's role in pioneering innovative cancer treatments.