ECC 2015: Combination of Dabrafenib and Trametinib Superior to Vemurafenib Alone in Advanced Melanoma

Access to the full content of this site is available only to registered healthcare professionals. Register to read more

The latest results from a trial of a combination of two targeted therapies (dabrafenib [Tafinlar] and trametinib [Mekinist]) to treat advanced melanoma have shown that patients are living significantly longer on the combined therapy than patients treated with vemurafenib (Zelboraf) alone. Caroline Robert, MD, PhD, of the Institut Gustave Roussy, presented these results at the 2015 European Cancer Congress in Vienna, Austria (Abstracts 3301, 3345).1,2

Dr. Robert reported that not only is the median overall survival longer for patients receiving the combination treatment but also that 51% of patients receiving the combination treatment are alive after 2 years, compared with 38% of patients receiving vemurafenib alone.

Analysis of data up to March 13, 2015, showed that the median overall survival among patients with metastatic melanoma harboring V600 mutations in the BRAF gene who received the combination treatment was 25.6 months. Among patients receiving vemurafenib alone, it was 18 months. On the basis of this finding, the European Commission approved the combination of dabrafenib and trametinib for use in Europe for these patients on September 1, 2015.

“We observed a statistically significant reduction of 34% in the risk of death among patients receiving the combination therapy,” Dr. Robert said. “The increased survival among these patients is remarkable, and this median overall survival of more than 2 years is the longest in this category of patients in a phase III randomized trial.”

These new results come from an analysis of all data from the COMBI-v phase III trial, which randomized previously untreated patients with the V600E or V600K mutations of the BRAF gene to receive either 150 mg of dabrafenib twice daily and 2 mg of trametinib once dail...