Saturday, June 03, 2023
Medivir AB, a pharmaceutical company dedicated to addressing unmet medical needs in cancer treatment, has announced an important development in their clinical study. They have successfully determined a safe dosage for the drug candidate fostroxacitabine bralpamide (fostrox) in combination with Keytruda® during the initial dose escalation phase (Phase 1b) of their ongoing 1b/2a study in hepatocellular carcinoma (HCC).
Moving forward, Medivir will focus on investigating the combination of fostrox and Lenvima in the expansion phase (Phase 2a) of the study. The company intends to explore the possibility of using fostrox as part of a triple combination therapy with immunotherapy in earlier treatment lines. This approach aims to overcome resistance development by utilizing different mechanisms of action, particularly considering that most first-line HCC patients are currently treated with Tecentriq®
(anti-PD-L1) in combination with Avastin®.
Medivir recognizes the limited potential for further immunotherapy response in subsequent lines of treatment after disease progression. As a result, the fostrox plus Keytruda® combination will not be further studied as a second-line therapy at present. Instead, with a safe dosage established for the fostrox plus Keytruda® arm, the company plans to explore fostrox as a potential partner in triple combination therapies with immunotherapy in earlier lines of treatment.
Dr. Pia Baumann, Medivir's Chief Medical Officer, expressed satisfaction with the completion of the dose escalation phase and the determination of a safe dosage for both treatment arms. The company is actively enrolling patients for the dose expansion phase, particularly for the fostrox plus Lenvima combination, which holds promise as an attractive option for second-line treatment in HCC. Medivir is also encouraged by the interest from clinical experts in exploring fostrox's potential as a combination partner with immunotherapy in earlier treatment lines, thanks to its unique mechanism of action that specifically targets the liver.
The clinical study involves combining fostrox with either Keytruda®, an anti-PD-1 checkpoint inhibitor, or Lenvima®, a tyrosine kinase inhibitor, in HCC patients who have shown inadequate response or intolerance to first-line treatment. The primary objectives of the study are to evaluate the safety, tolerability, and potential efficacy of fostrox in combination with these existing drugs. Medivir had previously announced the determination of a safe dosage for the fostrox plus Lenvima® combination in February, and since then, the expansion phase (Phase 2a) has commenced, with the administration of fostrox to the first 11 patients within a short period. The study is being conducted at 15 clinics across the United Kingdom, Spain, and South Korea.