Dabrafenib demonstrated clinical activity in patients with BRAF V600E mutation-positive non-small cell lung cancer (NSCLC), a study published in the journal The Lancet Oncology has shown.1

Activating BRAF V600E mutations are present in approximately 1-2% of lung adenocarcinomas. Because dabrafenib is an oral selective inhibitor of BRAF kinase, researchers sought to evaluate the clinical activity of dabrafenib in patients with advanced NSCLC positive for the BRAF V600E mutation.

For the multicenter, open-label, phase 2 trial, researchers enrolled 84 previously treated and treatment-naïve patients with stage 4 metastatic BRAF V600E mutation-positive NSCLC. Of those, only 6 had no previously received systemic treatment. All participants were treated with dabrafenib 150 mg orally twice daily.

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Results showed that the overall response rate was 33% (95% CI, 23-45) among the 78 previously treated patients. Of the previously untreated patients, 4 achieved an objective response.

The most common grade 3 or worse treatment-related adverse events were cutaneous squamous cell carcinoma (12%), asthenia (5%), and basal cell carcinoma (5%). Forty-two percent of patients experienced serious adverse events.

Of note, 1 patient died from an intracranial hemorrhage, which was deemed to be due dabrafenib treatment.

The findings ultimately suggest that dabrafenib could represent a novel treatment modality for a patient population with limited therapeutic options.

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Dabrafenib was initially approved by the U.S. Food and Drug Administration (FDA) as a single-agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, and in combination with trametinib for patients with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma.


  1. Planchard D, Kim TM, Mazieres J, et al. Dabrafenib in patients with BRAFV600E-positive advanced non-small-cell lung cancer: a single-arm, multicentre, open-label, phase 2 trial [published online ahead of print April 11, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(16)00077-2.