Pooled analysis of efficacy and safety of brigatinib in patients with ALK TKI-naïve advanced NSCLC with ALK mutation

Dr. Ross Camidge

Brigatinib is a next-generation oral ALK TKI approved to treat advanced ALK+ non-small cell lung cancer (NSCLC). Pooled analysis of the global phase 3 ALTA-1L trial and the Japanese phase 2 J-ALTA trial included 169 ALK-TKI naïve patients with ALK+ NSCLC (34% aged ≥ 65 years; 28% baseline brain metastases, 26% after previous chemotherapy). Brigatinib 180 mg was administered once daily following 7-day lead-in at 90 mg. The median progression-free survival by independent review committee was 29.3 months (95% CI 23.9-44.7). Confirmed objective response rate was 79%, with median duration of response 38.1 months. The intracranial ORR was 66% in patients with any brain metastases and 70% in patients with measurable brain metastases. Three-year overall survival rate was 74%. Grade 3 or 4 adverse events occurred in 74% of patients. The authors conclude that brigatinib demonstrated clinically meaningful systemic and intracranial efficacy in patients with ALK TKI-naïve ALK+ NSCLC.