publication date: Jun. 30, 2016

Melanoma Tafinlar-Mekinist Combination Shows Significant Benefit in BRAF V600E/K Population

Novartis published data from a phase III study showing a significant survival benefit for patients with BRAF V600E/K mutation-positive advanced melanoma when treated with the first-line combination of Tafinlar (dabrafenib) and Mekinist (trametinib), compared to Tafinlar monotherapy.

The results from the COMBI-d three-year follow-up analysis represent one of the longest survival follow-up studies to date with BRAF mutation-positive advanced melanoma patients, according to Novartis. Results were presented at the annual meeting of the American Society of Clinical Oncology.

“BRAF mutation remains the critical genetic feature in advanced melanoma that guides patients’ treatment options,” said Keith Flaherty, director of the Henri and Belinda Termeer Center for Targeted Therapies at Massachusetts General Hospital Cancer Center, and a professor of medicine at Harvard Medical School. “These results confirm that long-term survival can be achieved with this combination and it should be an important consideration for patients with BRAF mutation-positive advanced melanoma. It is particularly striking to note the excellent outcome for those with lower burden of disease at baseline.”

The COMBI-d study enrolled 423 patients with unresectable or metastatic BRAF V600E/K mutation-positive cutaneous melanoma and found the estimated three-year survival rate to be 44 percent for patients receiving the combination of Tafinlar and Mekinist (95% CI, 36.4%-50.5%) compared to 32 percent who received Tafinlar alone (95% CI, 25.4%-38.3%).

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