GlaxoSmithKline has stopped a Phase III study of its combination therapy for advanced cutaneous melanoma ahead of schedule after it showed a significant survival benefit.
The UK drug giant said an Independent Data Monitoring Committee (IDMC) has made the recommendation as it emerged patients with metastatic melanoma - carrying a BRAFV600 mutation - who took a combo of Mekinist (trametinib) and Tafinlar (dabrafenib) demonstrated an overall survival benefit compared to those taking vemarufenib.
Safety signals were also good, remaining consistent with that for the MEK inhibitor and BRAF inhibitor observed to date, the firm said.
GSK also noted that the Committee's recommendation is based on headline results and that further analysis of safety and efficacy data is underway and should be wrapped up in the "coming months".
The data will likley be used to support a refiling of Mekinist/Tafinlar in Europe; GSK withdrew its marketing application back in March after advisors indicated the data submitted at the time were not enough to support a favourable benefit-risk profile.
Combination use of GSK's drugs in patients with unresectable or metastatic melanoma who have BRAF V600E or K mutation is approved only in the US and Australia.