17th Jul 2014 13:21
LONDON (Alliance News) - GlaxoSmithKline PLC said Thursday that the Independent Data Monitoring committee has recommended that the Phase III study of its combination trametinib and dabrafenib treatment for BRAF V600E or V600K mutation positive metastatic cutaneous melanoma be stopped early.
The recommendation is based on an interim analysis which showed an overall survival benefit for the combination in comparison to the treatment vemurafenib, that cross the pre-specified efficacy stopping boundary.
The safety profile of the combination, also known under the brands mekinist and tafinlar, was consistent with the safety profile of the combination observed to date.
Further analysis of safety and efficacy data will be completed in the coming months, Glaxo said.
"We will continue to analyse this data versus vemurafenib over the coming months and look forward to sharing these with the scientific community once the analysis is complete," said Head of Oncology Research and Development Rafael Amado in a statement.
Shares in Glaxo were trading up 0.3% at 1,547.50 pence Thursday.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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