Fostrox + Lenvima demonstrates further improvement in durable clinical benefit in HCC, supporting the accelerated development plan
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Insights
The recent update on the phase 1b/2a study by Medivir AB indicates a significant milestone in the treatment of advanced hepatocellular carcinoma (HCC). The reported 80% disease control and >75% tumor shrinkage in patients post 12 weeks of treatment with fostroxacitabine bralpamide (fostrox) in combination with Lenvima is noteworthy. These results suggest a potentially effective second-line treatment for HCC, which is a leading cause of cancer-related deaths worldwide and often presents with limited treatment options after first-line therapy failure.
From a medical perspective, the combination's good safety and tolerability profile is crucial, as it implies a treatment that patients can sustain over time, which is particularly important in chronic conditions like cancer. The longest running patient showing a sustained partial response after 16 months is an encouraging sign of fostrox's potential for long-term efficacy. However, it is important to note that these results are still early and comprehensive data from the upcoming phase 2b study will be vital for a more definitive assessment.
For stakeholders, including investors and patients, these findings could signal the development of a more effective treatment regimen for HCC, potentially leading to improved patient outcomes and a stronger competitive position for Medivir in the oncology market. Nevertheless, the true impact on the market will depend on the outcomes of the phase 2b study, regulatory approvals and subsequent commercialization success.
The announcement by Medivir AB concerning its fostrox development program represents a critical juncture in the drug's clinical trajectory. The decision to accelerate the program into a registrational phase 2b study is indicative of the company's confidence in the drug's efficacy and safety profile. This is a positive signal to investors, as it suggests a potential for expedited time-to-market, subject to regulatory approval.
From an investment perspective, the data implies a robust pipeline product that could address a high unmet medical need in HCC treatment. The ability to control disease in 80% of patients at the 12-week mark is an impressive clinical outcome that could differentiate fostrox from other treatments currently available or in development. Moreover, the tolerability of the drug combination could lead to higher adoption rates among prescribing physicians, pending final approval.
Investors should also pay attention to the upcoming presentation at the ASCO Gastrointestinal Cancers Symposium, as additional data could provide further insights into fostrox's efficacy and safety, potentially affecting Medivir's stock performance. However, it is crucial to maintain a balanced view, considering the inherent risks of clinical development, including potential adverse findings in later-stage trials or regulatory challenges.
The strategic implications of Medivir AB's recent clinical update are significant for the company's financial outlook. The advanced stage of clinical development for fostrox, coupled with positive efficacy and safety data, may lead to increased investor confidence, potentially reflected in the company's stock valuation. The commitment to initiating a phase 2b study in 2024 indicates a clear pathway forward and the possibility of accelerated approval could be a catalyst for stock movement.
For investors, the potential market for second-line HCC therapies is substantial, given the disease's prevalence and limited effective treatments. Medivir's positioning in this space, therefore, represents a significant opportunity. However, it is essential to consider the full context of the competitive landscape, as well as the fact that the drug is not yet approved and thus does not guarantee revenue.
Furthermore, the company's engagement with the FDA to discuss final study design and the intent for accelerated approval is a critical step. Any positive feedback or guidance from the FDA could be a bullish signal for the stock. Nevertheless, investors should remain aware of the risks inherent in biopharmaceutical investing, particularly in the volatile oncology sector, where clinical and regulatory hurdles are common.
- Sustained disease control at 12 weeks has improved to
80% - Consistent anti-tumor activity, >
75% of patients experiencing tumor shrinkage in target lesions - Continued good safety and tolerability profile. Longest running patient still on treatment after 16 months with sustained partial response
The data is from a phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study evaluating the safety and efficacy with fostroxacitabine bralpamide (fostrox) in combination with Lenvima® in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. The study is ongoing with ~
- "Patients with advanced HCC, who have progressed on at least one prior line of treatment, is a difficult-to-treat population. Achieving durable clinical benefit for the majority of the patients with a good safety and tolerability profile, enables patients to benefit from the combination treatment longer. It provides us with added confidence in accelerating the fostrox development program and we look forward to engaging further with FDA to discuss final study design of the planned, registrational phase 2b study with accelerated approval intent," says Dr. Pia Baumann, CMO at Medivir.
Additional data from the ongoing phase 1b/2a study will be presented at the ASCO Gastrointestinal Cancers Symposium, January 18-20, 2024 in
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 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.
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. Medivir's share (ticker: 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.
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SOURCE Medivir
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