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Combination Therapy for Metastatic NSCLC With BRAF V600E Mutation Granted FDA Approval

Posted: Friday, June 23, 2017

On June 22, 2017, dabrafenib and trametinib combination therapy received regular approval from the U.S. Food and Drug Administration (FDA) for patients with metastatic non–small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. These FDA approvals are the first specifically for the treatment of patients with this type of metastatic lung cancer.

The FDA also approved a next generation–sequencing (NGS) test to detect multiple gene mutations for lung cancer in a single test from a single tissue specimen. The Oncomine™ Dx Target Test detects the presence of BRAF, ROS1, and EGFR gene mutations or alterations in tumor tissue of patients with NSCLC. This is the first NGS oncology panel test approved by the FDA for multiple companion diagnostic indications.

The study on which these approvals are based is Study BRF113928 (ClinicalTrials.gov identifier NCT01336634), an international, multicenter, three-cohort, nonrandomized, open-label trial in patients with locally confirmed BRAF V600E mutation–positive metastatic NSCLC. A total of 93 patients were treated with the combination of dabrafenib (150 mg orally twice daily) and trametinib (2 mg orally once daily). Of these 93 patients, 36 had received no prior systemic therapy for metastatic NSCLC.

The overall response rate for the combination therapy in those who had received prior therapy was 63%, with a median duration of response of 12.6 months. The overall response rate for the combination therapy in those who were previously treatment-naive was 61%, with a median duration of response not estimable; however, 59% of responders had response durations of more than 6 months. The overall response rate for patients who had received prior single-agent dabrafenib was 27%, with a median duration of response of 9.9 months.

The incidence and severity of adverse reactions occurring in patients with NSCLC were generally similar to those reported in prior approvals of the combination therapy for patients with melanoma. The most common adverse reactions (≥ 20%) were pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea.