publication date: Jul. 31, 2014

IDMC Halts Mekinist-Tafinlar Melanoma  Trial Early Due to OS Benefit; Recommends Crossover

An independent data monitoring committee recommended an early stop a phase III trial of Mekinist and Tafinlar in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma, following a demonstrated overall survival benefit.

The randomized, open-label study, named COMBI-v, compared the combination of Mekinist (trametinib) and Tafinlar (dabrafenib) to vemurafenib in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma.

Eligible patients who were randomized to the vemurafenib arm will be allowed to cross over to receive treatment with the Mekinist and Tafinlar combination.

The IDMC recommendation is based on headline data from an interim analysis that showed overall survival benefit crossing the pre-specified efficacy stopping boundary. The safety profile was consistent with previous observations of the combination. Further data analysis is underway and will be completed in the coming months, according to GlaxoSmithKline, which sponsors Mekinist and Tafinlar.

COMBI-v enrolled 704 patients in the U.S., Europe, Canada, Russia, Ukraine, Israel, Argentina, Brazil, Korea, New Zealand, Taiwan, and Australia. Secondary objectives evaluated progression-free survival, overall response rate, and duration of response.

Combination use of trametinib and dabrafenib in patients with unresectable or metastatic melanoma who have BRAF V600E or K mutation is approved only in the U.S. and Australia.

Addition of Cobimetinib Boosts PFS in BRAF Mutation-Positive Patients in Phase III Trial 

 

A phase III trial investigating a combination of the MEK inhibitor cobimetinib with the BRAF inhibitor Zelboraf increased progression-free survival, compared to Zelboraf alone, in patients with previously untreated BRAF V600 mutation-positive advanced melanoma.

Data from the study, named coBRIM, … Continue reading CCL July – IDMC Halts Mekinist-Tafinlar Melanoma Trial Early Due to OS Benefit; Recommends Crossover

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