Moffitt Cancer Center reports key role in FDA approval of Mekinist/Tafinlar for melanoma

Researchers at Moffitt Cancer Center have announced they were instrumental in studying the combination of trametinib and dabrafenib that recently received FDA approval for treating unresectable or metastatic melanoma in patients with BRAF V600E or V600K mutations.

“This new combination therapy is a huge step in the right direction for the treatment of melanoma, and our researchers played a large role in bringing this treatment option to patients,” Jeffrey S. Weber, MD, PhD, director of Moffitt’s Melanoma Research Center of Excellence, Tampa, Fla., said in a press release.

Jeffrey S. Weber

The FDA approved the combination of trametinib (Mekinist) and dabrafenib (Tafinlar; both GlaxoSmithKline) after granting a priority review designation. Approval was based on demonstration of response rate and median duration of response in a phase 1/2 study.

Keiran S. Smalley, PhD, scientific director of the research center, and his colleagues began investigating the MAP kinase pathway, in which trametinib and dabrafenib are used to block signaling in different sites, in 2010, according to the release. They learned that the optimal way to block the molecular pathway’s ability to promote cancer cell growth was through combination inhibitor therapy. BRAF-inhibitor resistance in patients with the mutation was prevented by using two inhibitors to block different pathways, the release said.

“A clinical trial in which Moffitt was the major contributor showed a 76% success rate for patients treated with the Mekinist and Tafinlar combination,” Weber said. “We also found this therapy reduced the incidence and severity of some of the toxic effects patients experienced when the drugs were used alone.”