A combined modality therapy of Rafinlar (ingredient: dabrafenib) and Meqsel (ingredient: trametinib) for metastatic non-small-cell lung cancer patients confirmed with BRAF V600E mutation began to receive insurance benefits on Monday.
BRAF V600E is a specific mutation in the BRAF gene, which makes a protein involved in sending signals in cells and cell growth. This genetic mutation may increase the growth and spread of cancer cells.
Patients with benign metastatic non-small-cell lung cancer account for 1-3 percent of non-small-cell lung cancer patients worldwide.
The patients with BRAF mutation desperately needed a new treatment because they had shorter disease-free survival period and life span compared to other patients.
The approval was based on the results of a global phase-2 clinical study, considering the urgent treatment for patients with BRAF V600E mutation-benign non-small-cell lung cancer.
The study evaluated 78 patients in the Rafinlar monotherapy group (cohort A), 57 patients in the Rafinlar-Meqsel combination group (cohort B), and 36 patients who had no anticancer therapy history in the combined therapy (cohort C).
The result showed that the cohort C group showed more clinically significant data. The Rafinlar-Meqsel group took 150 milligrams of Rafinlar twice a day and two milligrams of Meqsel each day.
Objective response rate, the percentage of patients whose cancer shrinks after treatment, of the cohort C group was 64 percent, and the median duration of response was 10.4 months. The median progression-free survival -- the time of patients living with the disease but not worsen -- was 10.9 months, and the median overall survival was 24.6 months.
"Rafinlar-Meqsel therapy is the first combined modality and targeted therapy for BRAF V600E mutated metastatic non-small-cell lung cancer patients," Novartis Korea said.