Dabrafenib (GSK) impressive in Metastatic Melanoma - 23-May-2012

A total of 184 patients with incurable solid tumours were enrolled (156 with Metastatic Melanoma) in a Phase 1 trial and given escalating doses of dabrafenib from Glaxo Smith Kline. The investigators established a recommended phase II dose (RP2D) of 150 mg twice daily.In the second stage, efficacy at the RP2D was studied in three groups of patients with BRAF-mutant tumours: those with advanced melanoma, with untreated melanoma brain metastases, and with other BRAF-mutant solid tumours.“Brain metastases in most [nine of ten] patients given dabrafenib reduced in size, with four patients’ metastases completely resolving”, explains Dr Gerald Falchook from the University of Texas MD Anderson Cancer Center in the USA, who is lead co-author of the study with Dr Georgina Long from Melanoma Institute Australia and Westmead Hospital in Sydney, Australia.“Patients with melanoma and brain metastases typically survive for less than 5 months; yet in this study, all ten patients were alive at this stage and two patients had durable antitumour activity with survival beyond 12 months. One patient remains on treatment at 19 months”.Dabrafenib moved to Phase III in January 2012.see "Dabrafenib in patients with melanoma, untreated brain metastases, and other solid tumours: a phase 1 dose-escalation trial"-Dr Gerald S Falchook MD, and others-May 19, 2012 The Lancet, Vol. 379 No. 9829 pp 1893-1901.