The data confirmed encouraging efficacy with a median overall survival of 13.7 months in second- or third line advanced liver cancer patients. All patients in the study had tumor progression on previous treatment but subsequently showed tumor reduction in >75% of the patients treated with fostrox + Lenvima. The tumor reduction correlated with reduction in AFP levels from baseline to 6 weeks that were seen in 79% of patients. This is encouraging as AFP is a liver cancer biomarker where high AFP levels negatively impact outcome. The result from this study showed that tumor reduction was seen independent of AFP levels (≥400 ng/mL<). The treatment with fostrox + Lenvima continued to be safe and tolerable with no unexpected new adverse events. The most common adverse events were temporary low neutrophil and platelet count with limited clinical impact, leading to fostrox dose adjustment (delay, reduction or discontinuation) at only 11 occasions throughout the study

The results from this study are encouraging considering the poor trajectory seen in second-line liver cancer where current available therapies have shown just 5 – 10% ORR, a typical TTP of only 3 – 4 months and median OS of 8-11 months.

“With these final results at a median follow-up of 10.5 months, fostrox + Lenvima have clearly shown promise of improved outcomes beyond current alternatives for second-line liver cancer patients. Fostrox is designed to only target tumor cells locally in the liver, without harming healthy cells, making it safe and tolerable also for longer term treatment. It is therefore encouraging to see that the second- and third line patients in our study have experienced substantially longer duration of benefit than previously seen in this patient population, as evidenced by the median overall survival of 13.7 months and median time to progression of 10.9 months. It is also reassuring to see that the response to treatment was seen independent of the patient’s AFP level at baseline. These final results have further strengthened our belief in fostrox as a potential treatment for patients with advanced liver cancer and we continue the work to initiate the planned, randomized phase 2b study comparing fostrox + Lenvima with Lenvima + placebo,” says Pia Baumann, Chief Medical Officer at Medivir.

The data presented at EASL are the final results from Medivir’s recently closed phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study, evaluating the safety and efficacy of fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable.