Tafinlar + Mekinist combo demonstrates overall survival benefit in melanoma

Novartis has announced updated data from the Phase III COMBI-v study showing a significant overall survival benefit for patients with BRAF V600E/K mutation-positive metastatic melanoma when treated with the combination of Tafinlar (dabrafenib) + Mekinist (trametinib) compared to vemurafenib monotherapy.

The combination also demonstrated significant health-related quality of life improvements, including overall health, physical and social functioning.

“It is remarkable to see so many patients with BRAF V600E/K mutation-positive metastatic melanoma having long term responses and obtaining a significant decrease of the risk of death as compared with vemurafenib monotherapy,” said Caroline Robert, MD, PhD, Head of Dermatology, Institute Gustave-Roussy. “This is the second Phase III trial of Tafinlar + Mekinist combination therapy to demonstrate a significant overall survival benefit over BRAF inhibitor monotherapy, further establishing Tafinlar + Mekinist as a standard of care for patients fighting BRAF V600 mutation-positive metastatic melanoma.”

The significant overall survival benefit of Tafinlar + Mekinist from COMBI-v is consistent with the results demonstrated by the combination in COMBI-d, another Phase III trial.

Tafinlar + Mekinist combo demonstrated a higher median overall response rate than vemurafenib

In the COMBI-v study, the combination of Tafinlar + Mekinist achieved a statistically significant overall survival (OS) benefit compared to vemurafenib monotherapy. The rate of OS at two years was 51% for those receiving the Tafinlar + Mekinist combination and 38% for those receiving vemurafenib monotherapy. In addition, the median overall response rate (ORR) was 65.6% in patients receiving the Tafinlar + Mekinist combination compared to 52.8% for those receiving vemurafenib monotherapy.

In August, the EC approved the combination of Tafinlar + Mekinist for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. In July, the US Food and Drug Administration (FDA) granted priority review for an application to obtain regular approval of the Tafinlar + Mekinist combination in BRAF V600E/K mutation-positive metastatic melanoma. Since January 2014, the combination of Tafinlar + Mekinist has been approved for use in the US in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test.