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Medivir presents promising results

Medivir has presented new data from its ongoing phase Ib/IIa study of fostroxacitabine bralpamide (fostrox) + Lenvima in advanced hepatocellular carcinoma (HCC) at the European Society of Medical Oncology, Gastrointestinal Cancers Cancers Congress in Munich, Germany.

The data shows an overall response rate (ORR) of 24%, with a disease control rate (DCR) of 81%, while the median TTP is now 10.8 months, with 25% of patients still on treatment. It also shows that one patient remains on treatment after 22 months, benefiting from a sustained partial response and biopsies confirm selective DNA damage to tumor cells, while there is no impact on normal liver function as measured by ALT/ AST levels and stable ALBI score over time.

The lack of impact on normal liver function supports the previously reported encouraging safety and tolerability profile, where only 5% of patients had to discontinue due to adverse events and the need for dose modification was lower than expected, reports Medivir.

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“With new data, including clear evidence of tumor selectivity, the clinical benefit of adding fostrox to Lenvima has greatly improved. We are particularly encouraged by the duration of benefit, with patients staying on treatment much longer than anticipated. Second-line hepatocellular carcinoma remains an indication with substantial need for improved outcomes for patients, with no approved treatment options after current standard of care. The data presented at ESMO GI makes us even more convinced of fostrox’s future potential in the treatment of HCC. We are now initiating study feasibility and finalizing the study protocol and synopsis which will lead to the opening of IND in the US, which is expected in H2 2024,” says Jens Lindberg, CEO at Medivir.

The data are from Medivir’s ongoing 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.

HCC

HCC is the most common type of liver cancer, accounting for more than 80% of cases worldwide. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent.

Photo of Jens Lindberg: Medivir

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