Medivir AB announced that all patients in the ongoing phase 2a study in advanced hepatocellular carcinoma (HCC) has now dosed at least two treatment cycles and the treatment continues to show very promising clinical benefit. The study evaluates safety and efficacy with the candidate drug fostrox in combination with Lenvima®? in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable.

The study, which is an open-label, multi-center, dose-escalation and dose-expansion study, continues to show early and durable clinical benefit across the cohort, as measured by local review. Of the 13 patients with sustained tumor control at 3 months, 3 patients achieved Partial Response and 10 patients Stable Disease, providing 17% Overall Response Rate (ORR) and 72% Disease Control Rate (DCR). The patient who has benefited the longer remains on treatment after 13.5 months, with sustained partial response.

The combination remains tolerable with no unexpected new safety events and adverse events are transient and manage. continued lower need for dose reductions or interruptions than expected. The observed tolerability is of outmost importance as patients with HCC often have an increased sensitivity to drugs in general due to impaired liver function.

"Overall, the consistent early and durable signals of clinical benefit and the favorable safety profile are very encouraging. The overall response rate of 17% already at 2nd scan is very encouraging and indicates a higher share of responders than historically seen in second line treatment of HCC. Medivir plans to provide an update in connection with the company's upcoming quarterly results presentation on October 27.

This will include a more comprehensive update of local review data as most of the patients will have had the opportunity to have at least three scans, with each scan scheduled to take place every 6 weeks. In addition to the data update, the company will also provide further context what these more mature data could mean for future clinical practice in second line HCC, a patient population for whom there are no approved medical treatments.