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 longest 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 manageable. 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. Patients with advanced HCC, who have progressed on at least one line of treatment, are a very difficult-to-treat population with few effective treatment options. 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. We can also see that for many patients, their target lesions continue to shrink with longer follow-up,' says Dr.
Contact:
Tel: +46 8 5468 3100
Email: magnus.christensen@medivir.com
About fostrox
Fostrox is an oral pro-drug, designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.
About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1). HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.
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