Thomas E. Stinchcombe, MD, discusses the results of the randomized phase III ALTA-1L trial in ALK-positive non–small cell lung cancer.
Thomas E. Stinchcombe, MD, professor of medicine, Duke Cancer Institute, discusses the 2-year updated results of the randomized phase III ALTA-1L trial in ALK-positive non—small cell lung cancer.
At a median follow-up of 25 months, the investigator-assessed median progression-free survival (PFS) was 29.4 months (95% CI, 21.2—not estimated [NE]) with brigatinib (Alunbrig) versus 9.2 months (95% CI, 7.4-12.9) with crizotinib (Xalkori) in the intent-to-treat population of patients with ALK-positive NSCLC who had not received prior treatment with an ALK inhibitor. Blinded independent review committee (BIRC)—assessed median PFS was 24.0 months (95% CI, 18.5-NE) and 11.0 months (95% CI, 9.2-12.9) with brigatinib and crizotinib, respectively.
Additionally, the intracranial objective response rate for patients with measurable brain metastases at baseline was 78% with brigatinib versus 26% with crizotinib.
The toxicities associated with brigatinib appear to be manageable, says Stinchcombe. Notably, health-related quality of life was improved for patients treated with brigatinib versus those treated with crizotinib.
In April 2017, the FDA granted an accelerated approval to brigatinib for the treatment of patients with ALK-positive NSCLC who have progressed on or are intolerant of crizotinib.