Dr. Sullivan on Targeted Therapy for BRAF-Mutant Melanoma

Ryan J. Sullivan, MD
Published: Monday, Feb 19, 2018



Ryan J. Sullivan, MD, instructor of Medicine, Harvard Medical School, assistant in medicine, MGH Cancer Center, Massachusetts General Hospital, discusses novel molecular targets in patients with melanoma.

About 40% to 50% of patients with melanoma have a BRAF mutation. There are a series of therapies that have been developed and are FDA approved for the treatment of those patients, explains Sullivan. These include dabrafenib (Tafinlar), trametinib (Mekinist), and vemurafenib (Zelboraf), which are approved as single-agents for the treatment of BRAF-mutant melanoma. These 3 agents are also being looked at in combination.

In December 2017, the FDA granted a priority review to a supplemental new drug application for the use of dabrafenib combined with trametinib as an adjuvant treatment for patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.

This is based off the phase III COMBI-AD study in which adjuvant treatment with dabrafenib and trametinib reduced the risk of relapse or death by 53% compared with placebo for patients with BRAF-mutant stage III melanoma. After a median follow-up of 2.8 years, the 3-year relapse-free survival rate with dabrafenib and trametinib was 58% compared with 39% for placebo (HR, 0.47; 95% CI, 0.39-0.58; P <.001).
 


Ryan J. Sullivan, MD, instructor of Medicine, Harvard Medical School, assistant in medicine, MGH Cancer Center, Massachusetts General Hospital, discusses novel molecular targets in patients with melanoma.

About 40% to 50% of patients with melanoma have a BRAF mutation. There are a series of therapies that have been developed and are FDA approved for the treatment of those patients, explains Sullivan. These include dabrafenib (Tafinlar), trametinib (Mekinist), and vemurafenib (Zelboraf), which are approved as single-agents for the treatment of BRAF-mutant melanoma. These 3 agents are also being looked at in combination.

In December 2017, the FDA granted a priority review to a supplemental new drug application for the use of dabrafenib combined with trametinib as an adjuvant treatment for patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.

This is based off the phase III COMBI-AD study in which adjuvant treatment with dabrafenib and trametinib reduced the risk of relapse or death by 53% compared with placebo for patients with BRAF-mutant stage III melanoma. After a median follow-up of 2.8 years, the 3-year relapse-free survival rate with dabrafenib and trametinib was 58% compared with 39% for placebo (HR, 0.47; 95% CI, 0.39-0.58; P <.001).
 

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Community Practice Connections™: Precision Medicine for Community Oncologists: Assessing the Role of Tumor-Testing Technologies in Cancer CareNov 30, 20181.0
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