Dr. Hauschild Discusses the Dabrafenib BREAK-3 Trial

Axel Hauschild, MD
Published: Tuesday, Jun 26, 2012

Axel Hauschild, MD, of University Hospital, Schleswig-Holstein, Germany, discusses the phase III, randomized, BREAK-3 trial that compared the BRAF inhibitor dabrafenib to dacarbazine for patients with BRAFV600E-mutated metastatic melanoma.

Hauschild notes that the BREAK-3 trial was similar in design to the BRIM3 trial that investigated the BRAF inhibitor vemurafenib in advanced melanoma. The two trials both enrolled only patients with confirmed BRAFV600E-mutations; however, they used different tests to detect the V600E mutation. The BRIM3 trial used the now FDA approved cobas 4800 BRAF v600 test and the BREAK-3 trial confirmed the mutation using an allele-specific PCR assay, developed by a GSK collaborator. The V600E mutation occurs in approximately 90% of all BRAF mutations – an abnormality that occurs in 40-50% of all melanoma patients.

In the trial, 250 patients with previously untreated, unresectable, stage III or IV BRAFV600E-mutated melanoma were randomized 3:1 to receive either dabrafenib or dacarbazine. The median progression-free survival for the dabrafenib arm was 5.1 months compared to 2.7 months in the dacarbazine arm.

Axel Hauschild, MD, of University Hospital, Schleswig-Holstein, Germany, discusses the phase III, randomized, BREAK-3 trial that compared the BRAF inhibitor dabrafenib to dacarbazine for patients with BRAFV600E-mutated metastatic melanoma.

Hauschild notes that the BREAK-3 trial was similar in design to the BRIM3 trial that investigated the BRAF inhibitor vemurafenib in advanced melanoma. The two trials both enrolled only patients with confirmed BRAFV600E-mutations; however, they used different tests to detect the V600E mutation. The BRIM3 trial used the now FDA approved cobas 4800 BRAF v600 test and the BREAK-3 trial confirmed the mutation using an allele-specific PCR assay, developed by a GSK collaborator. The V600E mutation occurs in approximately 90% of all BRAF mutations – an abnormality that occurs in 40-50% of all melanoma patients.

In the trial, 250 patients with previously untreated, unresectable, stage III or IV BRAFV600E-mutated melanoma were randomized 3:1 to receive either dabrafenib or dacarbazine. The median progression-free survival for the dabrafenib arm was 5.1 months compared to 2.7 months in the dacarbazine arm.


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