Novartis reports positive data for new combination melanoma therapy

Novartis has announced the findings of a phase III clinical trial that demonstrates the significant benefits of a new combination melanoma therapy.

The COMBI-AD assessed the performance of a combination of Tafinlar and Mekinist among 870 patients with stage III BRAF V600E/K mutation-positive melanoma after complete surgical resection.

The primary endpoint of the trial was achieved after a statistically significant 53 percent reduction was seen in the risk of death or recurrence in patients treated with the BRAF and MEK inhibitor combination therapy compared to placebo.

Clinically meaningful improvements were also seen across various secondary endpoints, including overall survival, distant metastasis-free survival and freedom from relapse.

This represents the first adjuvant targeted therapy combination to demonstrate a clinical benefit in patients with a BRAF V600 mutation.

Vas Narasimhan, global head of drug development and chief medical officer at Novartis, said: "The COMBI-AD data results address a significant unmet need in patients with stage III melanoma. We look forward to discussing the results with regulatory authorities worldwide."

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