An Independent Data Monitoring Committee recently recommended that a clinical study of the combination treatment Mekinist™ (trametinib) plus Tafinlar™ (dabrafenib) versus Zelboraf® (vemurafenib) for metastatic cutaneous melanoma patients be stopped early so that those receiving Zelboraf could cross over and begin taking the combination therapy instead. The committee made the recommendation after an interim analysis showed an overall survival benefit threshold had been met by the combination therapy.
Cutaneous melanoma is the most aggressive form of all skin cancers, killing over 37,000 people worldwide this year. The incidence of melanoma for men in the U.S. continues rise faster than any other cancer. For women, only lung cancer has a faster rising incidence.
The phase III study randomized 704 patients with unresectable (Stage IIIC) or metastatic (Stage IV) cutaneous melanoma to a combination therapy or to Zelboraf. Researchers were interested primarily in overall survival rate. Secondary objectives of the study included evaluating progression-free survival, overall response rate, duration of response, and safety of the treatment. The safety profile of the combination arm was consistent with what had been previously observed.
While the overall survival endpoint was met by the combination therapy, the Independent Data Monitoring Committee will continue to analyze safety and efficacy data moving forward.
Reference: GlaxoSmithKline. (7/17/14). Trametinib (Mekinist™) and dabrafenib (Tafinlar™) combination demonstrated overall survival benefit compared to vemurafenib; phase III BRAF V600-mutant metastatic melanoma study stopped early [Press Release]. Retrieved from http://www.gsk.com/media/press-releases/2014/trametinib–mekinist–and-dabrafenib–tafinlar–combination-demo.html.