Axel Hauschild, MD, PhD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) for the adjuvant treatment of adult patients with BRAF
V600E– or V600K–positive stage III melanoma following complete resection.
Adverse events (AEs) were experienced by 97% of those treated with dabrafenib and trametinib versus 88% with placebo. The rates of grade 3/4 AEs were 41% and 14% for the combination and placebo, respectively. Overall, AEs led to discontinuation for 26% of those in the combination arm versus 3% with placebo. The most common all-grade AEs, which were mostly grade 1/2, with the combination were pyrexia (63%), fatigue (47%), and nausea (40%). There were no fatal adverse events with the combination of dabrafenib and trametinib.
- Hauschild A, Santinami M, Long GV, et al. COMBI-AD: Adjuvant dabrafenib (D) plus trametinib (T) for resected stage III BRAF V600E/K–mutant melanoma. Presented at: 2017 ESMO Congress; Madrid, Spain; September 8-12, 2017. Abstract LBA6_PR.
- Long GV, Hauschild A, Santinami M, et al. Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma. N Engl J Med. Published online September 10, 2017. DOI: 10.1056/NEJMoa1708539.
... to read the full story