STOCKHOLM - Medivir AB (Nasdaq Stockholm: MVIR), a Swedish pharmaceutical company, announced significant clinical advancements for its cancer drug fostrox in combination with Lenvima® in treating advanced hepatocellular carcinoma (HCC). The latest results from an ongoing phase 1b/2a study indicate an increased overall response rate (ORR) to 25% and a median time to progression of 5.1 months, with over 40% of patients still undergoing treatment.
The study, which will be presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco on January 19, has shown that the combination therapy not only provides a clinical benefit but also maintains a good safety and tolerability profile. According to Dr. Pia Baumann, Chief Medical Officer at Medivir, the updated data supports the potential of fostrox plus Lenvima as a treatment for patients with advanced HCC, particularly those with poor prognosis.
The research involves patients for whom first- or second-line treatments have been ineffective or intolerable. The combination therapy has been well-tolerated with only 5% of participants discontinuing fostrox due to adverse events, and fewer dose reductions than expected were needed. A notable disease control rate of 61% at 18 weeks suggests a majority of patients experience continuous clinical benefit.
Dr. Maria Reig, an investigator in the study, noted the clear unmet need for safe and effective combination treatments in HCC, a complex disease. The promising outcomes warrant further investigation in a randomized, controlled trial, she added.
Medivir plans to accelerate the fostrox development program and will engage with regulatory authorities to discuss the final study design for a registrational phase 2b study with accelerated approval intent, expected to commence in 2024. The company will host a conference call on January 23 to provide additional details and discuss plans moving forward with fostrox.
Fostrox, a smart chemotherapy, is designed to selectively deliver cell-killing compounds to tumors, minimizing harm to normal cells. It is administered orally and targets the liver directly. The drug's unique mechanism positions it as a potential first liver-targeted, orally administered treatment for various liver cancers.
HCC, the most common primary liver cancer, is the third leading cause of cancer-related deaths worldwide. Existing therapies offer limited benefits, and the high death rate signifies a substantial unmet medical need. Annually, around 660,000 people are diagnosed with primary liver cancer globally, with a five-year survival rate of less than 20%.
This article is based on a press release statement from Medivir AB.
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