24th Jan 2014 13:00
LONDON (Alliance News) - GlaxoSmithKline PLC said Friday that its Phase III study of the combination treatment of Tafinlar and Mekinist for the treatment of metastatic melenoma had reached its primary endpoint.
The company said the response rate and interim overall survival results in the study were similar to those seen in the Phase I/II study.
"These results, along with data we expect to receive later in the year from our Phase III study comparing the combination to vemurafenib, will increase the body of evidence on the safety and efficacy of this combination in appropriate patients with melanoma," said Senior Vice President of Oncology Research and Development Rafael Amado in a statement.
The combined treatment was granted approval from the US Food and Drug Administration on January 9. The approval followed results from Glaxo's Phase I/II study and was contingent on the results from the ongoing Phase III trial.
The Phase III trials investigated progression-free survival in patients receiving the combination compared to those only receiving therapy with dabrafenib, the active ingredient Tafinlar. In Mekinist, the active ingredient is trametinib.
Another trial is assessing the overall survival in patients treated with the combination compared to another treatment called vemurafenib.
Glaxo said that results from the trials of dabrafenib only had shown higher progression-free survival than in previous trials, which led to a more modest difference with the combination trials than in previous studies.
Trametinib was in-licensed by GSK in 2006. It holds the worldwide exclusive rights to develop and commercialise Mekinist, with the exception of Japan where Japan Tobacco retains co-promotion rights.
Shares in Glaxo were trading down 1.0% at 1,636.00 pence Friday afternoon.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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