Novartis reports Phase 3 data on Tafinlar-Mekinist in melanoma
Novartis announced data from the Phase III COMBI-v study demonstrating 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 and Mekinist compared to vemurafenib monotherapy. The results of the study, which was conducted in 704 patients, are being presented at the European Society for Medical Oncology 2016 Congress. Results from the COMBI-v study found the estimated three-year survival rate to be 45% of patients receiving the combination of Tafinlar + Mekinist compared with 31% of patients who received vemurafenib monotherapy. 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% for the combination arm and 10%m for the vemurafenib monotherapy arm. At three years of follow up, the combination of Tafinlar + Mekinist continued to demonstrate a benefit on the measures of duration of response and overall response rate, in line with results seen at the two-year follow up analysis. The safety results were consistent with the profile observed to date for the combination and consistent with the profile observed for vemurafenib monotherapy; no new safety concerns were observed.