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Clinical Trial
. 2016 Mar 10;34(8):871-8.
doi: 10.1200/JCO.2015.62.9345. Epub 2016 Jan 25.

Overall Survival and Durable Responses in Patients With BRAF V600-Mutant Metastatic Melanoma Receiving Dabrafenib Combined With Trametinib

Georgina V Long  1 , Jeffrey S Weber  2 , Jeffrey R Infante  2 , Kevin B Kim  2 , Adil Daud  2 , Rene Gonzalez  2 , Jeffrey A Sosman  2 , Omid Hamid  2 , Lynn Schuchter  2 , Jonathan Cebon  2 , Richard F Kefford  2 , Donald Lawrence  2 , Ragini Kudchadkar  2 , Howard A Burris 3rd  2 , Gerald S Falchook  2 , Alain Algazi  2 , Karl Lewis  2 , Igor Puzanov  2 , Nageatte Ibrahim  2 , Peng Sun  2 , Elizabeth Cunningham  2 , Amy S Kline  2 , Heather Del Buono  2 , Diane Opatt McDowell  2 , Kiran Patel  2 , Keith T Flaherty  2
Affiliations
Clinical Trial

Overall Survival and Durable Responses in Patients With BRAF V600-Mutant Metastatic Melanoma Receiving Dabrafenib Combined With Trametinib

Georgina V Long et al. J Clin Oncol. .

Erratum in

  • Errata.
    [No authors listed] [No authors listed] J Clin Oncol. 2019 Feb 1;37(4):355. doi: 10.1200/JCO.18.02267. J Clin Oncol. 2019. PMID: 30695654 Free PMC article. No abstract available.

Abstract

Purpose: To report the overall survival (OS) and clinical characteristics of BRAF inhibitor-naive long-term responders and survivors treated with dabrafenib plus trametinib in a phase I and II study of patients with BRAF V600 mutation-positive metastatic melanoma.

Methods: BRAF inhibitor-naive patients treated with dabrafenib 150 mg twice daily plus trametinib 2 mg daily (the 150/2 group) from the non-randomly assigned (part B) and randomly assigned (part C) cohorts of the study were analyzed for progression-free and OS separately. Baseline characteristics and factors on treatment were analyzed for associations with durable responses and OS.

Results: For BRAF inhibitor-naive patients in the 150/2 groups (n = 78), the progression-free survival at 1, 2, and 3 years was 44%, 22%, and 18%, respectively, for part B (n = 24) and 41%, 25%, and 21%, respectively, for part C (n = 54). Median OS was 27.4 months in part B and 25 months in part C. OS at 1, 2, and 3 years was 72%, 60%, and 47%, respectively, for part B and 80%, 51%, and 38%, respectively, for part C. Prolonged survival was associated with metastases in fewer than three organ sites and lower baseline lactate dehydrogenase. OS at 3 years was 62% in patients with normal baseline lactate dehydrogenase and 63% in patients with a complete response.

Conclusion: Dabrafenib plus trametinib results in a median OS of more than 2 years in BRAF inhibitor-naive patients with BRAF V600 mutation-positive metastatic melanoma, and approximately 20% were progression free at 3 years. Durable responses occurred in patients with good prognostic features at baseline, which may be predictive.

Trial registration: ClinicalTrials.gov NCT01072175.

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