COMBI-d: A randomized, double-blinded, Phase III study comparing the combination of dabrafenib and trametinib to dabrafenib and trametinib placebo as first-line therapy in patients (pts) with unresectable or metastatic BRAF^V600E/K mutation-positive cutaneous melanoma

Dabrafenib in combination with trametinib for the treatment of metastatic melanoma

“…The initial analysis of COMBI-d for PFS and OS has been performed and was presented at the American Society of Clinical Oncology 2014 Annual Meeting. Specifically, the trial met its primary end point of PFS reduction (HR: 0.75; p = 0.035) and, based on interim analysis, appears to be associated with an OS benefit as well (HR: 0.63; p = 0.023), both favoring combination therapy [22]. Similarly, though only released to date via Press Release, the COMBI-v trial appears to have met its primary end point, meaning that the combination was superior to single-agent vemurafenib with regards to OS (press release 18 July 2014; GlaxoSmithKline).…”

The MEK inhibitor trametinib for the treatment of advanced melanoma

“…Recently, the FDA approved the combination of trametinib and dabrafenib based on a randomized Phase II trial that demonstrated that this regimen improved median PFS and response rates compared to dabrafenib [13]. A randomized Phase III trial comparing dabrafenib/trametinib versus dabrafenib (NCT01 597908) has very recently been reported [14]. This study demonstrated a benefit in terms of the PFS for the combination arm with hazard ratio (HR) of 0.75 (95% CI: 0.57, 0.99; p = 0.035).…”

“…Confirmed objective responses occurred more frequently with combination therapy (76 vs 54%) as did complete responses (9 vs 4%). A randomized Phase III trial comparing dabrafenib/trametinib versus dabrafenib in patients with BRAF V600 -mutant melanoma (NCT01597908) has very recently been reported [14]. It demonstrated a benefit in terms of the PFS for the combination arm with HR of 0.75 (95% CI: 0.57, 0.99; p = 0.035).…”

ASCO 2014: news, hopes, hypes?

“…The trial, called COMBI-d [7], compared the new treatment to dabrafenib alone and confirmed that the combination treatment performs better: 93 % of the patients who took dabrafenib/trametinib were alive after 6 months, compared with 85 % of the patients who took only dabrafenib.…”