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ASCO 2019: Survival Update on Dabrafenib Plus Trametinib in BRAF V600–Mutant Melanoma

By: Sarah Campen, PharmD
Posted: Wednesday, June 26, 2019

In an extended analysis of the phase III COMBI-d and COMBI-v trials, researchers found a 5-year overall survival rate of 34% in patients with BRAF V600–mutant unresectable or metastatic melanoma who received first-line treatment with dabrafenib plus trametinib. The pooled 5-year landmark data, which were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract 9507), also revealed that overall survival at 5 years was 71% among the 109 patients with a complete response.

“First-line treatment with dabrafenib plus trametinib leads to durable long-term benefit in many patients with BRAF V600–mutant unresectable or metastatic melanoma,” stated Paul D. Nathan, MD, of Mount Vernon Cancer Centre, Northwood, United Kingdom, and colleagues.

The analysis included 563 patients with previously untreated BRAF V600E/K–mutant unresectable or metastatic melanoma. They were assigned to receive dabrafenib at 150 mg twice daily plus trametinib at 2 mg once daily in the COMBI-d (n = 211) and COMBI-v (n = 352) trials. Progression-free survival was 21% at 4 years and 19% at 5 years; overall survival was 37% at 4 years and 34% at 5 years. The 5-year overall survival rate was considerably higher in patients with normal baseline lactate dehydrogenase (LDH) levels than in those with elevated LDH levels at baseline (43% vs. 16%, P < .001).

Of the 299 patients who received subsequent anticancer therapy after treatment with dabrafenib plus trametinib, 51% received an anti–CTLA-4 therapy and 34% received an anti–PD-1 therapy. No new safety signals were reported. Dr. Nathan and colleagues plan to perform exploratory analyses to identify subgroups of patients who are most likely to experience a long-term benefit from this combination therapy.

Disclosure: The study authors’ disclosure information may be found at coi.asco.org.



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