Drug Combo Increased Lifespan in Melanoma

Patients with advanced melanoma are living longer when treated with a combination of two targeted therapies, dabrafenib and trametinib than those solely given another drug, vemurafenib.

Caroline Robert, MD, PhD, Institut Gustave Roussy, Paris, France, recently shared her team’s findings at the 2015 European Cancer Congress.

Anti-BRAF treatment by itself has been linked to more than half of the patients relapsing after six to eight months, researchers aimed to investigate whether a combination would ultimately produce better outcomes.

Robert and colleagues analyzed data from 2012 to July 2014 from the COMBI-v phase III trial, which randomized untreated patients with V600E or V600K BRAF mutations to receive either 150 mg dabrafenib twice daily and 2 mg trametinib once a day or only 960 mg vemurafenib twice a day.

Positive study results showed a significant increase in the lifespan among patients given the combination therapy.

According to Roberts, “The increased survival among these patients is remarkable, and this median overall survival of more than two years is the longest in this category of patients in a phase III randomized trial."

Targeted therapies, dabrafenib, vemurafenib, and trametinib work by blocking BRAF and MEK proteins in the cell signaling pathways typically overactive in cancer.

Since 349 of the 704 patients had died in March 2015, the researchers had to extend follow up for 18 more months. The prolonged analysis found no reports of unexpected adverse events and that overall health, physical and social functioning, and specific symptoms such as pain, insomnia, loss of appetite, diarrhea, and fatigue were also all improved.

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The European Commission recently approved the dabrafenib and trametinib drug combination on September 1 after data was released confirming the median survival time for metastatic melanoma patients who received the combination treatment was more than two years (25.6 months).

However, the median survival rate was only 18 months in the patients who were only given the single treatment of vemurafenib.

“This combination therapy is already available in the US and now also in Europe as a result of the European Commission’s decision to approve its use. This long-term benefit in terms of overall survival confirms the major potential of this combination in patients with metastatic melanoma. A further question to investigate is the combination treatment versus new immunotherapies or combined with them,” concluded Robert.