GlaxoSmithKline's Tafinlar-Mekinist Combination Treatment For Melanoma Achieves Phase III Endpoint
GlaxoSmithKline announced that Phase III study results for the Tafinlar (dabrafenib) and Mekinist (trametinib) combination therapy in metastatic melanoma met its primary endpoints. The announcement follows the recent accelerated approval of the combined treatment in the US.
GlaxoSmithKline Oncology R&D Senior Vice President Dr. Rafael Amado said, “We are pleased to report that the first of our phase III studies investigating the combination of Tafinlar and Mekinist met its primary endpoint. These results, along with data we expect to receive later in the year from our Phase III study comparing the combination to vemurafenib, will increase the body of evidence on the safety and efficacy of this combination in appropriate patients with melanoma.”
The Tafinlar-Mekinist therapy is a combination of oral targeted treatments for unresectable or metastatic melanoma with BAF V600 E or K mutations. Both drugs have received FDA approval as monotherapies last year and combination therapy approval earlier this month.
Melanoma is a life-threatening form of skin cancer. The disease caused approximately 9,480 deaths in the US last year. Tafinlar and Mekinist are used to treat advanced forms of melanoma that cannot be effectively removed by surgery.
Phase III program for the combination therapy constitutes COMBI-d and COMBI-v studies. The company stated, “Today’s results are from COMBI-d (NCT01584648) a Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to dabrafenib and placebo as first-line therapy in patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. The primary endpoint of the study is progression-free survival (PFS) and patients will be followed for overall survival.”
Results showed that PFS increased in Phase III, particularly in patients given monotherapy, compared to Phase I/II results. Trial results from 423 patients from investigative sites in Europe, Australia, North and South America were randomized for the study. The company expects results from the continuing COMBI-v study this year.
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