Novartis: Tafinlar + Mekinist Demonstrate Superior Overall Survival Benefit

(RTTNews) - Novartis (NVS) announced data from the Phase III COMBI-v study showing an overall survival and a progression-free survival benefit for patients with BRAF V600 mutation-positive advanced melanoma when treated first-line with the combination of Tafinlar (dabrafenib) + Mekinist (trametinib) compared to vemurafenib monotherapy.

Advanced melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates.

Novartis plans to present the results of this study, which was conducted in 704 patients, at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen.

Results from the COMBI-v study found the estimated three-year survival rate to be 45% of patients receiving the combination of Tafinlar + Mekinist (95% CI, 39.1%-49.8%) compared with 31% of patients who received vemurafenib monotherapy (95% CI, 26.1%-36.4%). There were 34 patients who crossed over from the vemurafenib monotherapy arm to the combination arm after the combination demonstrated a significant OS benefit in a prior analysis. Additionally, the estimated three-year progression-free survival rate was 24% (95% CI, 19.4%-28.8%) for the combination arm and 10% (95% CI, 5.9%-14.5%) for the vemurafenib monotherapy arm.