Promising tumor control for fostrox in combination with Lenvima in ongoing phase 2a study in HCC, 15th patient included

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Medivir AB (MVIR) Announces Positive Preliminary Results from Phase 2a Study of Fostrox + Lenvima® in Advanced Hepatocellular Carcinoma Patients

• Continued tumor control in the liver in 7 of the first 10 patients after three months of treatment
• The patient who benefited the longest from fostrox + Lenvima® remains on treatment after 12 months, with tumor reduction maintained
• Consistently good safety and tolerability profile

STOCKHOLM, Aug. 14, 2023 /PRNewswire/ -- Medivir AB (Nasdaq: MVIR) (Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that the 15th patient with advanced hepatocellular carcinoma (HCC) has been included in the ongoing phase 2a study. 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 preliminary results from the initial phase 1b part were positive with a good safety and tolerability profile. The study, which is an open-label, multi-center, dose-escalation and dose-expansion study, continues to show encouraging clinical results as the disease has been stabilized in the majority of patients and they remain on treatment.

The interest in including patients in the ongoing phase 2a study with fostrox + Lenvima® has been great among both investigators and patients. The combination remains tolerable and only one patient has discontinued treatment due to side effects related to fostrox. Furthermore, the need for dose reductions has been lower 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.

"The rapid inclusion of patients in phase 2a is a clear sign that the combination of fostrox and Lenvima® is seen as an attractive treatment option and that the medical need for a new, effective treatment for HCC is large. We are very encouraged by the early signals of efficacy and good tolerability, and we look forward with confidence to presenting the data in more detail at an upcoming scientific congress," says Dr. Pia Baumann, CMO at Medivir.

The promising observations in the phase 1b/2a study mean that Medivir, together with its Scientific Advisory Council, is intensifying preparations for the next phase in the clinical development of fostrox. 

For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: magnus.christensen@medivir.com 

About fostrox
Fostrox is a 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.

About Medivir
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a pro-drug designed to selectively treat liver cancer and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Birinapant, a SMAC mimetic, is exclusively outlicensed to IGM Biosciences (Nasdaq: IGMS) to be developed in combination with IGM-antibodies for the treatment of solid tumors. Medivir's share (Nasdaq: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com.

1) Rumgay et al.,European Journal of Cancer 2022 vol.161, 108-118.

The following files are available for download:

https://mb.cision.com/Main/652/3817048/2226345.pdf

Press release (PDF)

 

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SOURCE Medivir

FAQ

What is the focus of Medivir AB's phase 2a study?

The phase 2a study focuses on evaluating the safety and efficacy of the candidate drug fostrox in combination with Lenvima® in patients with advanced hepatocellular carcinoma (HCC) for whom current first- or second-line treatment has proven ineffective or is not tolerable.

What are the preliminary results from the initial phase 1b part of the study?

The preliminary results from the initial phase 1b part were positive, showing a good safety and tolerability profile, with encouraging clinical results as the disease has been stabilized in the majority of patients who remain on treatment.

What is the significance of the observed tolerability of the treatment combination?

The observed tolerability is significant as patients with HCC often have increased sensitivity to drugs due to impaired liver function, and the combination of fostrox and Lenvima® has shown to be tolerable with only one patient discontinuing treatment due to side effects related to fostrox.

What are the future plans for Medivir AB based on the promising observations in the study?

Based on the promising observations, Medivir, along with its Scientific Advisory Council, is intensifying preparations for the next phase in the clinical development of fostrox.