A post-marketing surveillance study of dabrafenib and trametinib combination in Japanese patients with unresectable advanced or recurrent BRAF-mutated NSCLC.

Combination therapy with dabrafenib and trametinib has been shown to improve response and survival outcomes in patients with BRAF V600E-mutated non-small cell lung cancer (NSCLC). However, safety and efficacy data in Japanese patients with unresectable NSCLC are limited in clinical trials. This post marketing surveillance study investigated the safety and effectiveness of dabrafenib and trametinib in Japan between March 2018 and August 2023. Most patients included in the safety analysis set (N = 76) had stage IV NSCLC (82.89%) and Eastern Cooperative Oncology Group performance status 0 or 1 (85.53%). Adverse events (AEs) occurred in 70 patients (92.11%); the most common AEs (≥ 5%) were pyrexia (46.05%), progression of NSCLC (38.16%), and rash (13.16%). Incidences of adverse drug reactions of safety specifications were pyrexia (46.05%), rhabdomyolysis (11.84%), and hepatic impairment and cardiac disorder (10.53% each). In the overall response rate (ORR) analysis set (n = 64), ORR was 67.19% (95% confidence interval [CI], 54.31-78.41%). Seventy-four patients were analyzed for progression-free survival (PFS); PFS rates (95% CI) at 182 days and 364 days were 71.07% (58.79-80.29%) and 49.64% (37.17-60.91%), respectively. Median PFS (95% CI) survival was 364 days (246.00 to not estimable). Real-world data observed in this surveillance study were similar to those reported previously.