Impressive Results’ From Stage III Melanoma Studies: ASCO 2020

Source: Medscape, August 2020

COMBI-AD is an adjuvant trial in resected stage IIIA, IIIB, and IIIC melanoma (per the American Joint Committee on Cancer [AJCC] 7th edition criteria) in patients who had completion lymphadenectomies. The study was a large randomized, blinded phase 3 study of 870 patients where there was an excellent balance between dabrafenib/trametinib for 1 year vs placebo.

This study has now matured. Now at 5 years of follow-up (minimum of 59 months), the primary endpoint of relapse-free survival (RFS) shows a significant difference, with 53% RFS [in the treatment arm] vs 36% for the placebo arm. If you break it down by stage (using the AJCC 7th criteria), the 5-year RFS was 65% for IIIA, 55% for IIIB, and 45% for IIIC. As you would expect, there is a decrement downward with each substage.

In looking at the distant metastasis-free survival, a surrogate for overall survival, there was a significant difference of 65% [in the treatment arm] vs 54% [in the placebo arm], for an absolute difference of 11%.

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