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Benefits of BRAF Inhibitor Confirmed in Metastatic Melanoma
Major Finding: Tumor shrinkage of at least 30% was reported in 52% of patients.Data Source: Phase II open-label trial in 132 patients with...
During the past 30 years, only two drugs – dacarbazine and interleukin-2 – have been approved by the Food and Drug Administration for treating metastatic melanoma, and while these drugs help control the disease in a small percentage of patients, they do not appear to improve survival.
However, agents introduced within the last 2 years are reported to improve survival, Dr. Richard D. Carvajal of Memorial Sloan-Kettering Cancer Center, said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).
Dr. Richard D. Carvajal
The first is ipilimumab (also known as MDX-010 or MDX-101), a monoclonal antibody that binds to cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). Normally, CTLA-4 slows the immune system, but this treatment allows the immune system to recognize melanoma, Dr. Carvajal said.
In one study reported last year, ipilimumab improved overall survival in patients with previously treated metastatic melanoma (N. Engl. J. Med. 2010;363;711-23). Specifically, patients who received ipilimumab plus glycoprotein 100 (gp100) had an overall survival of 10 months, while those who received gp100 alone had a survival rate of 6.4 months. The median overall survival for patients taking ipilimumab alone was 10.1 months.
The second treatment, PLX4032 (also known as RG7204 or RO5185426), works by inhibiting the mutated BRAF protein found in about half of all cases of metastatic melanoma. In January, the manufacturer, Plexxikon, announced that a phase III clinical study showed a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma.
Study participants who received PLX4032 lived longer (overall survival) and also lived longer without their disease getting worse (progression-free survival), compared with participants who received dacarbazine, the current standard of care, Dr. Carvajal said, adding "these are really large breakthroughs."
Dr. Carvajal disclosed that he has served as a consultant for Novartis. SDEF and this news organization are owned by Elsevier.