The global, randomized, phase III ALTA-1L (ALK in Lung Cancer Trial of AP26113 in 1st Line) trial met its primary endpoint at the first prespecified interim analysis, with brigatinib (Alunbrig) demonstrating a statistically significant improvement in progression-free survival (PFS) compared to crizotinib (Xalkori) in adults with anaplastic lymphoma kinase (ALK)–positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who had not received a prior ALK inhibitor. The trial was designed to assess the efficacy and safety of brigatinib in comparison to crizotinib based on evaluation of the primary endpoint of PFS. Brigatinib is currently not approved as frontline therapy.
The safety profile associated with brigatinib from the ALTA-1L trial was generally consistent with the existing prescribing information, with no new safety concerns.
The results from this interim analysis will be submitted for presentation at an upcoming medical meeting.
More About the ALTA-1L Trial
The ongoing ALTA-IL trial enrolled 275 patients with ALK-positive locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor. Patients received either brigatinib 180 mg once daily with 7-day lead-in at 90 mg once daily, or crizotinib 250 mg twice daily. Independent Review Committee (IRC)-assessed progression-free survival (PFS) was the primary endpoint. Secondary endpoints included objective response rate (ORR) per RECIST v1.1, intracranial ORR, intracranial PFS, overall survival (OS), safety, and tolerability. A total of approximately 198 PFS events are planned at the final analysis of the primary endpoint in order to demonstrate a minimum of 6 months PFS improvement over crizotinib. The trial is designed with two prespecified interim analyses for the primary endpoint—one at 50% of planned PFS events and one at 75% of planned PFS events.
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