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Method of Adjuvant Cancer Treatment

Inactive Publication Date: 2015-08-06
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a method of giving assisted treatment to patients who have had melanoma removed. This involves giving them medication called dabrafenib and trametinib for a period of time to increase the chances of them remaining cancer-free. This combination of medications is also offered for use in this purpose.

Problems solved by technology

However, patients with lymph node involvement including those detected only by sentinel lymph node biopsy, are at high risk of both local and distant relapse after definitive surgery due to the frequent presence of distant micrometastatic disease at presentation (Kirkwood et al.
Although significant progress has been made recently with new treatments for metastatic melanoma, therapeutic options in the adjuvant setting remain limited.
Although high-dose interferon is currently the only approved therapy for the adjuvant treatment of melanoma it is not widely accepted as the standard of care.
Increasing evidence surrounding a questionable survival benefit, a high incidence of serious toxicities, and negligible benefit for patients with bulkier disease makes it an unattractive therapy for most patients and clinicians (Schuchter, 2004).

Method used

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  • Method of Adjuvant Cancer Treatment
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Embodiment Construction

[0010]The RAS / RAF / MEK / ERK pathway (i.e., the MAP kinase pathway) is a critical proliferation pathway in many human cancers, including melanoma. Oncogenic mutations in BRAF signal through MEK1 and MEK2, and occurrence of this is an early event. This study will evaluate the combination of two small-molecules, oral agents, dabrafenib and trametinib. Dabrafenib is a potent and selective RAF kinase inhibitor of human wild type BRAF and CRAF enzymes as well as the mutant forms BRAFV600E, BRAFV600K and BRAFV600D. The mode of action of dabrafenib is consistent with competitive inhibition of adenosine triphosphate (ATP) binding. By contrast, trametinib is a reversible, highly selective, allosteric inhibitor of MEK1 and MEK2. Trametinib is non-competitive towards ATP and inhibits both MEK activation and kinase activity. Because BRAF and MEK are in the same pathway, and because MEK is a substrate of activated BRAF and other kinases that can be activated in presence of BRAF inhibition, inhibiti...

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Abstract

The present invention provides a method of providing adjuvant treatment to a human patient which comprises administering to such a patient therapeutically effective doses of dabrafenib and trametinib for a time period sufficient to increase relapse-free survival (RFS).

Description

BACKGROUND OF THE INVENTION[0001]This invention relates to a method of treating subjects after complete resection of cutaneous melanoma.[0002]Cutaneous melanoma is the most aggressive form of all skin cancers. Although it represents only 4% of all cancers, its incidence is continuing to rise in the world at a rate exceeding all other cancers (Jemal A, Siegel R, Ward E et al. Cancer statistics, 2007. CA Cancer J Clin 2007; 57: 43-66). Worldwide it is expected that approximately 132,000 people will be diagnosed with melanoma each year and approximately 37,000 people are expected to die of the disease annually (World Health Organization (WHO). Skin cancers. In Ultraviolet radiation and the INTERSUN Programme. Retrieved 7 Feb. 2012).[0003]Surgical resection is the treatment of choice for localized melanoma and frequently results in cures for early stage (I and II) disease, with a 90% long term (10-year) survival rate for stage I disease Balch et al., Final Version of 2009 AJCC Melanoma ...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K31/506
CPCA61K31/506A61K31/519A61K2300/00A61P17/00A61P35/00A61P43/00
Inventor LAQUERRE, SYLVIELEBOWITZ, PETER F.
Owner NOVARTIS AG
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