Medivir AB announced further improved clinical benefit with fostrox + Lenvima®? as data from the ongoing phase 1b/2a study in advanced hepatocellular carcinoma (HCC) will be presented at the ASCO (American Society of Clinical Oncology) GI (Gastrointestinal Cancers) Symposium in San Francisco on January 19. The updated data further supports accelerating the fostrox development program to initiate a registrational phase 2b study in second-line HCC in 2024.

The data is from a phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study evaluating the safety and efficacy with fostroxacitabine bralpamide (fostrox) in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. With a high and durable disease control rate of 61% at 18 weeks, the majority of patients in this study have continuous clinical benefit. "Hepatocellular cancer is a particularly complex disease," says Dr. Maria Reig, Director of the Barcelona Clinic Liver Cancer (BCLC) and the Liver Oncology Unit at the Hospital Clinic of Barcelona in Spain, and investigator in the fostrox + Lenvima study.

"A clear unmet need remains for safe and effective combination treatments. These data show that fostrox + Lenvima have encouraging results related to clinical outcome in patients with second-line advanced HCC without jeopardizing safety. I look forward to further explore the efficacy of fostrox added to Lenvima in a randomized, controlled trial".

The results from the phase 1b/2a trial will be presented by Dr Maria Reig, poster number 476P, at ASCO GI on January 19. Medivir will host a conference call to provide additional details from the study, comments on the data and the plans moving forward with fostrox, at 14.00 CET on January 23, 2024. The prodrug design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver.

With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b/2a, is a Phase 1b/2a study will be presented by Dr. Maria Reig, poster number 3,000P, at ASCO GI.