Medivir’s CEO: “The IND approval is a very important milestone”
Medivir has secured FDA approval to proceed with a phase IIb trial evaluating fostrox in combination with Lenvima for second-line treatment of advanced liver cancer. The trial will evaluate the combination’s effect compared to Lenvima alone, building on encouraging phase Ib/IIa results, aiming to bevome the first, approved treatment option in second-line liver cancer. We reached out to CEO Jens Lindberg for a comment.
Medivir has announced FDA clearance for its Investigational New Drug (IND) application to evaluate fostrox in combination with Lenvima in a randomized phase IIb trial. The trial targets patients with advanced hepatocellular carcinoma (HCC) who have already received immunotherapy-based treatments.
The phase IIb study builds on promising findings from the recently closed phase 1b/2a trial, where the combination demonstrated manageable safety and encouraging anti-tumor activity, including a median time to progression (TTP) of 10.9 months. Medivir plans to recruit participants from eight countries across the U.S., Europe, and Asia, with results expected by 2027.
The company’s focus on liver cancer stems from its growing global impact, with HCC being the fastest-growing cancer in the US and among the top causes of cancer-related deaths worldwide. Current HCC therapies provide limited benefits, leaving patients with a poor five-year survival rate of less than 20 percent, highlighting the need for novel approaches.
What the phase IIb trial entails
The trial will compare fostrox plus Lenvima with Lenvima alone in patients with advanced liver cancer who have progressed on first-line immunotherapy. The study’s primary endpoint is the Objective Response Rate, with secondary outcomes including duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety, and quality of life.
The trial will be led by Principal Investigator Prof. Maria Reig, a globally recognized expert and Director of the Barcelona Clinic Liver Cancer. Prof. Reig emphasizes the critical unmet need for effective and liver-tolerable therapies in this patient population, noting that fostrox shows potential to fill this gap without compromising liver function.
Comments from the CEO
We spoke with Medivir’s CEO Jens Lindberg to discuss the significance of the IND approval and its impact on partnering discussions.
Jens, can you elaborate on the significance of FDA’s IND approval?
– The IND approval is of great importance as it means that the FDA has approved our proposed study design and it allows us to include US patients in the phase 2b study. FDA is at the forefront of enabling innovative treatments that fill significant unmet medical gain regulatory approval and reach the market faster. But in order to qualify for programs such as Breakthrough Therapy Designation and Accelerated Approval, the study must include US patients, which is why this IND approval is so important.
How does fostrox address the challenges of preserving liver function in HCC patients?
– Fostrox has been designed to selectively kill cancer cells in the liver. The cell killing effect of fostrox will only impact cells that are dividing, which is the key. The reason for this is that while healthy liver cells very rarely divide, cancer cells in the liver divide much more frequently. As a result, cancer cells will be killed as soon as they divide and are exposed to fostrox whereas healthy cells that are not dividing are not impacted. As the liver is a critical organ metabolizing food and removing toxins from the body, among other things, it is extra important not to harm normal liver function.
What led to the decision to conduct the study across multiple countries on three continents?
– The significant unmet medical need is a global challenge. It is one of the deadliest and fastest growing cancers, to a large extent driven by obesity and fatty liver disease, which increases the risk of liver cancer significantly. It has therefore been important for us to design a global study that includes patients with all ethnicities to ensure we maximise the chance of early regulatory approvals in all regions. Including patients across USA, Europe and Asia will also make fostrox more attractive for potential partnering discussions.
What role do you see fostrox playing in the broader treatment landscape for HCC?
– Fostrox is unique in a number of ways and has the potential to transform second-line liver cancer treatment. It is the only oral, liver-targeted treatment in development and its mechanism of action selectively killing cancer cells locally in the liver is also unique. As a result, it has the potential to become the first, approved treatment option in combination with Lenvima in second-line liver cancer. Looking into the future, as fostrox is the only drug targeting the liver, it has the potential to be combined with all other treatment options used in liver cancer, including earlier treatment lines.
Finally, what impact could the IND approval have on your partnering processes?
– It is an important step. The commercial opportunity in the US is significant and it is the best opportunity to reach the market as fast as possible. Therefore, in any partnering process, the ability to include US patients and enable the potential for accelerated approval will also be a very valuable component for a potential partner.
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