GSK Presents Updated Results from Phase III BREAK-3 Study of Tafinlar® (dabrafenib)


Results from the planned analysis of the Phase III BREAK-3 study in 250 patients with BRAF V600E mutant metastatic melanoma show benefit for the use of GSK's Tafinlar (dabrafenib) over dacarbazine (DTIC).

Forty-five percent of patients treated with dabrafenib only were alive at two years, compared to 32 percent of patients who began treatment with DTIC. Fifty-nine percent of patients on DTIC treatment whose disease progressed subsequently received dabrafenib treatment and are included in the DTIC control arm results.

BREAK-3 is a phase III, randomised, open-label study comparing 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.

Dr. Paolo Paoletti, President of Oncology, GSK said, “We are encouraged by the 45 percent 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.”

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