D. Ross Camidge, MD, PhD
Updated data from the phase III ALTA-1L trial were presented by D. Ross Camidge, MD, PhD, of the University of Colorado Cancer Center, Aurora, during the Presidential Session at the European Society for Medical Oncology (ESMO) Asia Congress 2019 in Singapore.1 The trial evaluated brigatinib vs crizotinib in adults with advanced anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who had not received a prior ALK inhibitor. Results showed that after more than 2 years of follow-up, brigatinib reduced the risk of disease progression or death by 76% (hazard ratio [HR] = 0.24, 95% confidence interval [CI] = 0.12–0.45), as assessed by investigators in newly diagnosed patients whose disease had spread to the brain at the time of enrollment. Brigatinib also demonstrated a 57% reduction in the risk of disease progression or death in all patients (HR = 0.43, 95% CI = 0.31–0.61).
The findings from the ALTA-1L trial were evaluated by two separate review bodies—study investigators and a blinded independent review committee—and results from both assessments were reported. At the data cutoff for the second interim analysis (June 28, 2019), the blinded independent review committee–assessed hazard ratio of progression-free survival, the primary endpoint, was 0.49 (95% CI = 0.35–0.68, log-rank P < .0001), demonstrating a reduced risk of disease progression or death by 51%.
Additional data from the long-term analysis showed that newly diagnosed patients treated with brigatinib benefited regardless of the presence or absence of brain metastases at baseline, which is one of the most common sites of first disease progression and associated with poor quality of life. The safety profile of brigatinib in the ALTA-1L trial was generally consistent with the existing U.S. prescribing information.
About the ALTA-1L Trial
The phase III ALTA-1L trial of brigatinib in adults was a global, ongoing, randomized, open-label, comparative, multicenter trial, which enrolled 275 patients (brigatinib, n = 137, crizotinib, n = 138) with ALK-positive locally advanced or metastatic NSCLC who had not received prior treatment with an ALK inhibitor. Patients received either brigatinib at 180 mg once daily with a 7-day lead-in at 90 mg once daily or crizotinib at 250 mg twice daily.
The median age of patients was 58 years in the brigatinib arm and 60 years in the crizotinib arm. A total of 29% of patients had brain metastases at baseline in the brigatinib arm vs 30% in the crizotinib arm. A total of 26% of patients received prior chemotherapy for advanced or metastatic disease in the brigatinib arm vs 27% in the crizotinib arm. ■
DISCLOSURE: For full disclosures of the study authors, visit esmo.org.
1. Camidge R, Kim HR, Ahn M, et al: Brigatinib vs crizotinib in patients with ALK inhibitor-naive advanced ALK+ NSCLC: Updated results from the phase III ALTA-1L trial. ESMO Asia Congress 2019. Presented November 23, 2019.