Medivir’s phase Ib/IIa study successfully concluded
Medivir has announced the conclusion of its phase Ib/IIa study evaluating fostrox in combination with Lenvima for second- or third-line treatment of advanced liver cancer. The remaining patients have been transitioned to a compassionate use program, ensuring continued treatment access.
– We are very satisfied that the remaining three patients can now transition to a compassionate use solution, enabling them to continue to benefit from fostrox and maintain control over their liver cancer, says Jens Lindberg, CEO of Medivir.
Medivir is advancing fostrox to establish it as the first approved treatment option following first-line standard care for hepatocellular carcinoma (HCC). Fostrox has been tested in a phase Ib/IIa study in combination with the established cancer treatment Lenvima (lenvatinib). In September, Medivir presented data from the study at the ESMO congress, highlighting a significantly improved efficacy for the combination treatment compared to what could be expected with Lenvima alone.
The results show that the patients can be treated longer than expected, evidenced by a median Time to Progression of 10.9 months. This is substantially longer than previously seen in second-line HCC. Watch BioStock’s video interview from ESMO with Dr. Pia Baumann, Medivir’s CMO, here.
The phase I/IIb study has been concluded
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 benefitting from the treatment. The company plans to present end-of-treatment data at an upcoming scientific congress.
– We can now close the study and focus all our efforts on the planned randomized phase 2b study of fostrox in combination with Lenvima as we strive to make the combination the first, approved treatment option in second-line advanced HCC, says Pia Baumann.
The collaboration with Eisai
The conclusion of the phase Ib/IIa study also marks the culmination of an eventful period that sets the stage for a larger phase IIb trial. Recently, Medivir signed an extended clinical collaboration with Eisai to conduct a randomized phase IIb study comparing fostrox plus lenvatinib to lenvatinib monotherapy as a second-line treatment for HCC. Read more here.
In a recent telephone conference, Medivir’s CEO Jens Lindberg noted the advantages of this agreement, highlighting Eisai’s commitment to covering the costs of the drug substance lenvatinib for the upcoming trial. These costs, which would have amounted to at least MUSD 15 million, have been alleviated, significantly reducing uncertainty around drug supply and strengthening Medivir’s position in ongoing partnership discussions.
The upcoming phase IIb study
The objective of the forthcoming phase IIb study, planned for next year, is to build on the promising findings from the phase Ib/IIa trial. The study aims to deliver results that further validate the observed potential of fostrox + Lenvima and meet the criteria for regulatory pathways such as Breakthrough Therapy Designation and accelerated approval.
Comments from the CEO
In a comment to BioStock, Medivir’s CEO Jens Lindberg says:
– The most encouraging signal seen with the fostrox + Lenvima combination is the extended duration of benefit as patients have stayed much longer on treatment than what is expected on currently available treatments, which is why it has been so important to find a solution for patients to continue stay on treatment after we close the study. We are very satisfied that the remaining three patients can now transition to a compassionate use solution, enabling them to continue to benefit from fostrox and maintain control over their liver cancer.
If you missed it, watch Lindberg’s presentation at the 2024 BioStock Life Science Summit, held on November 20-21, here.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
