GSK reports positive results from Phase III BREAK-3 trial of tafinlar to treat melanoma

Source: September 2014

GlaxoSmithKline (GSK) has reported updated results from a Phase III BREAK-3 trial of Tafinlar (dabrafenib) in patients with BRAF V600E mutant metastatic melanoma.

The results, related to a secondary endpoint from the 250-patient trial, showed that 45% of patients treated with dabrafenib were still alive at two years compared to 32% of patients who started treatment with dacarbazine (DTIC).

The company has already reported analysis of the trial’s primary endpoint, progression free survival (PFS) in 2012 and intends to report final analysis of the overall survival (OS) endpoint in 2016.

The randomised, open-label BREAK-3 trial compared the efficacy, safety, and tolerability of dabrafenib to DTIC in patients with advanced (Stage III) or metastatic (Stage IV) melanoma who harbour a BRAF V600E mutation.

In this trial, patients with previously untreated BRAF V600E mutation-positive metastatic melanoma were randomly assigned to receive dabrafenib 150mg twice daily, orally, or DTIC 1000mg/m2 intravenously every three weeks.

The primary endpoint of the trial was PFS, while secondary prespecified endpoints included OS.

GSK president of Oncology Dr Paolo Paoletti said the company is happy by the 45% survival rate with dabrafenib at two years.

“Treatments for melanoma have come a long way in recent years and we’re now seeing the benefits precision medicines can bring to the right patients,” Paoletti said.

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