– We are very pleased that the three remaining patients can now transition to compassionate use, which enables them to continue to benefit from fostrox and maintain control over their liver cancer, says Medivir's CEO Jens Lindberg.
Medivir develops fostrox with the goal of becoming the first approved treatment option after the standard treatment for hepatocellular carcinoma (HCC). Fostrox has been tested in a phase Ib/IIa study with fostrox in combination with the established cancer treatment Lenvima (lenvatinib). Medivir presented data at ISMOcongress, which shows a significantly improved effect with the combination treatment compared to what can be expected with Lenvima alone.
The results also show that patients can be treated for longer than expected, with a median Time to Progression (TTP) of 10,9 months. This is significantly longer than previously seen in second-line treatment in HCC. Watch BioStock's live interview from ESMO with Medivir's Chief Medical Officer, Dr. Pia Baumann here.
The Phase Ib/IIa study has been completed
Medivir has now completed the Phase Ib/IIa study evaluating fostrox + Lenvima. The remaining patients have been transferred to a compassionate use program where they can continue to benefit from the treatment. The company plans to present data covering the full treatment period at an upcoming scientific conference.
– We can now conclude the study and focus fully on the planned, randomized phase 2b study of fostrox in combination with Lenvima with the ambition to make the combination the first, approved treatment option in second-line advanced HCC, says Dr. Pia Baumann.
The collaboration with Eisai
The completion of the Phase Ib/IIa study also marks the end of an eventful period that paves the way for a larger Phase IIb study. Recently, Medivir signed an expanded clinical collaboration with Eisai to conduct a randomized phase IIb study comparing fostrox and lenvatinib with lenvatinib as monotherapy in second-line HCC treatment. Read more here.
In a recent conference call, Medivir's CEO highlighted Jens Lindberg The benefits of the agreement and emphasized that Eisais will cover the costs of the drug substance lenvatinib in the upcoming study. These costs, which would otherwise have amounted to at least 15 million USD, have thus been eliminated, significantly reducing uncertainty around drug supply and strengthening Medivir's position in ongoing partnership discussions.
The upcoming phase IIb study
The planned Phase IIb study, expected to begin next year, aims to build on the promising results from the Phase Ib/IIa study. The goal is to deliver results that further validate the potential of fostrox + Lenvima and meet regulatory benefit criteria such as Breakthrough Therapy Designation and Accelerated Approval.
Comment from the CEO
In a comment to BioStock, Medivir's CEO says Jens Lindberg:
– The most promising signal with the fostrox + Lenvima combination is the prolonged clinical benefit, as patients have been able to remain on treatment significantly longer than is expected with the treatments available today. Therefore, it has been important to find a solution for patients to continue treatment after the study has ended. We are very pleased that the three remaining patients can now transition to a compassionate use solution, which allows them to continue to benefit from fostrox and maintain control of their liver cancer.
Did you miss Jens Lindberg's presentation at BioStock Life Science Summit 2024, which took place on November 20–21? See it here.