GlaxoSmithKline (GSK) has received approval from the US Food and Drug Administration (FDA) for the use of Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations.
The combination was approved through the FDA’s accelerated approval programme and reviewed under a priority review designation.
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The approval was granted following successful demonstration of response rate and median duration of response in a Phase I/II study.
The trial evaluated the combination of trametinib and dabrafenib at the recommended dose (150/2mg) (N=54) and single-agent dabrafenib (150mg) (N=54).
However, the Mekinist-Tafinlar combination has not demonstrated improvement in disease-related symptoms or overall survival.
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Results from a Phase I/II trial showed that the investigator-assessed overall response rate was 76% for patients treated with the combination of Mekinist and Tafinlar, versus 54% for those given Tafinlar alone.
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By GlobalDataMeanwhile, the median duration of response was 10.5 months for patients treated with the combination, compared with 5.6 months for those treated with single-agent dabrafenib.
The company said that Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma.
In the trial, improvement in disease-related symptoms or overall survival has not been demonstrated for Mekinist in combination with Tafinlar.
The accelerated approval is contingent on the results of the ongoing Phase III trial (referred to as MEK115306 or Combi-D), which is aimed at assessing the clinical benefit of the combination in patient population.
GSK president of Oncology Paolo Paoletti said combining agents that target different mechanisms regulating the growth of cancer cells is a promising areas in cancer research.
"We are proud that the first approved combination of targeted therapies in metastatic melanoma is Mekinist and Tafinlar, and our hope is that it will become part of the new standard of care for appropriate patients with BRAF V600E or V600K mutation-positive metastatic melanoma," Paoletti added.
Image: Histopathologic image of malignant melanoma. Photo: courtesy of KGH.
