GSK reports positive OS results from Phase III trial of combination melanoma drug

8th February 2015 (Last Updated February 8th, 2015 18:30)

GlaxoSmithKline (GSK) has reported positive overall survival (OS) results from a Phase III COMBI-d trial of dabrafenib (Tafinlar) and trametinib (Mekinist) combination in patients with BRAF V600E/K mutation-positive metastatic melanoma.

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GlaxoSmithKline (GSK) has reported positive overall survival (OS) results from a Phase III COMBI-d trial of dabrafenib (Tafinlar) and trametinib (Mekinist) combination in patients with BRAF V600E/K mutation-positive metastatic melanoma.

The results show a statistically significant reduction in the risk of death for this combination therapy compared to dabrafenib monotherapy in these patients.

Data from the trial also showed that the safety profile was consistent with the profile observed to date for the combination and no new safety concerns were observed.

GSK Pharmaceuticals R&D president Patrick Vallance said: "These final overall survival results from COMBI-d, the second phase III study to show positive survival results for the combination compared to BRAF inhibitor monotherapy, further reinforce the scientific rationale for combining MEK and BRAF inhibitors and underscore the potential of the combination of dabrafenib and trametinib in the treatment of BRAF V600 mutation-positive metastatic melanoma."

In the coming months, the final data from this Phase III trial will be submitted to regulatory authorities for review.

The trial compared the combination of dabrafenib and trametinib, to single agent therapy with dabrafenib and placebo in patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma.

The randomised, double-blinded Phase III trial randomised a total of 423 patients from investigative sites in Australia, Europe and North and South America.

The trial's primary endpoint was investigator assessed progression-free survival (PFS), while secondary endpoints included OS, objective response rate (ORR), duration of response (DoR) and safety.

The company said that the combination use of trametinib and dabrafenib in patients with unresectable or metastatic melanoma who have BRAF V600E/K mutation is approved in the US and Australia.


Image: GlaxoSmithKline headquaters in London, UK. Photo: Courtesy of Maxwell Hamilton.