BASEL (dpa-AFX) - Swiss drug giant Novartis (NVS) announced Monday that Phase III study demonstrated adjuvant Tafinlar (dabrafenib) + Mekinist (trametinib) reduced the risk of disease recurrence by 53% in patients with resected BRAF V600 mutation-positive melanoma.
The study was of 870 patients with stage III BRAF V600E/K mutation-positive melanoma after complete surgical resection.
The company noted that findings from the COMBI-AD study, which met its primary endpoint, found a statistically significant 53% reduction in the risk of death or recurrence in patients treated with the BRAF and MEK inhibitor combination therapy versus placebo.
The results of the study will be presented during the Presidential Symposium today at the European Society for Medical Oncology Congress in Madrid, and were simultaneously published in the New England Journal of Medicine.
Lead investigator Axel Hauschild said, 'These unprecedented results confirm a targeted therapy combination has the potential to transform the standard of care in the melanoma adjuvant setting.'
In a separate study, Novartis presented Phase II results from BRF113928, showing efficacy for patients with BRAF V600E-mutant metastatic non-small cell lung cancer without prior systemic therapy for metastatic disease when treated with the combination of Tafinlar + Mekinist.
Copyright RTT News/dpa-AFX
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