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July 17, 2014 at 3:12 pm #22106Catherine PooleKeymaster
“Trametinib (Mekinist™) and dabrafenib (Tafinlar™) combination demonstrated overall survival benefit compared to vemurafenib; phase III BRAF V600-mutant metastatic melanoma study stopped early
GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the Independent Data Monitoring Committee (IDMC) recommended COMBI-v (MEK116513), a phase III study of its MEK inhibitor, trametinib (Mekinist™), in combination with its BRAF inhibitor, dabrafenib (Tafinlar™), compared to vemurafenib in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma be stopped early. This IDMC recommendation is based on an interim analysis which demonstrated an overall survival benefit for the trametinib and dabrafenib combination compared to vemurafenib that crossed the pre-specified efficacy stopping boundary. The safety profile of the trametinib and dabrafenib arm was consistent with the safety profile of the combination observed to date.
The IDMC recommendation today is based on headline data; further analysis of safety and efficacy data is underway and will be completed in the coming months. Eligible study patients who were randomised to the vemurafenib arm will be allowed to cross over to receive treatment with the trametinib and dabrafenib combination.
Dr. Rafael Amado, Head of Oncology R&D at GSK, said: “Today’s headline results for the combination of dabrafenib and trametinib add to the body of evidence our phase III program has provided thus far, which we hope will more fully characterise the efficacy and safety profile of this combination for patients with BRAF V600-mutant metastatic melanoma. 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.”October 2, 2014 at 7:54 am #65012rick1981Participant
Hereby the latest from ESMO (European ASCO equivalent) summit:October 2, 2014 at 2:48 pm #65013Jolly_SimonParticipant Been in Zel three months now and appears to be working, first ct scan since taking it next week to confirm, but very nice to hear there is other options coming as I knows Zel won’t work forever.
Thanks for posting.October 20, 2014 at 9:35 am #65014rick1981Participant
Catherine, did you hear any news from ESMO? Our MD mentioned some positive results on the BRAF/MEK combo as presented by Caroline Robert…
Too technical for me
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