These findings emerged as data from the Phase 3 COMBI-v study (NCT01597908) were presented at the European Society for Medical Oncology (ESMO) 2016 Congress, held Oct. 7–11 in Copenhagen.
The study, which began in 2012, included 704 patients with unresectable or metastatic melanoma with the V600E/KBRAF, who were randomized to receive either the Tafinlar plus Mekinist combination or the BRAF blocker Zelboraf (vemurafenib).
Earlier studies have shown that the two drugs are more effective when used together than either drug alone. Tafinlar and Mekinist target different proteins, BRAF and MEK1/2 respectively, from a signaling pathway that has been implicated in melanoma, lung cancer, and other cancers.
“The three-year overall survival follow-up data from COMBI-v is remarkable because it is the second Phase III study this year to demonstrate a significant long-term survival benefit for BRAF mutation-positive melanoma patients treated with Tafinlar + Mekinist combination therapy compared to BRAF inhibitor monotherapy,” Caroline Robert, MD, PhD, head of Dermatology, Institute Gustave-Roussy in France, said in a news release.
“The results of this trial continue to reinforce Tafinlar + Mekinist as a standard of care and sets a new benchmark for treating patients with BRAF V600 mutation-positive advanced melanoma.”
The trial showed that 45 percent of patients receiving the combination treatment were alive at three years, compared to 31 percent treated with Zelboraf. Following an earlier analysis finding significantly better overall survival in patients given Tafinlar and Mekinist, 34 patients from the Zelboraf group crossed over to the combination treatment.
The three-year progression-free survival rate was 24 percent in the combination group and 10 percent in the Zelboraf group. Also, duration of response measurements continued being beneficial, and in line with data from the previous year. No new safety issues were detected during the trial.
The trial was stopped early by the Independent Data Monitoring Committee (IDMC) when the interim analysis showed that the combination was more effective than Zelboraf.
“These results underscore our commitment to advancing the practice of precision oncology and extending patients’ lives through treatment options that target the root cause of their cancer,” said Alessandro Riva, MD, Global Head, Oncology Development & Medical Affairs at Novartis.