Interim data from phase III ALTA-1L trial of Alunbrig meets primary endpoint in non-small cell lung cancer.- Takeda.

Takeda announced that 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 pre-specified interim analysis, with Alunbrig (brigatinib) demonstrating a statistically significant improvement in progression-free survival (PFS) compared to crizotinib in adults with anaplastic lymphoma kinase-positive (ALK+) locally advanced or metastatic non-small cell lung cancer (NSCLC) who had not received a prior ALK inhibitor. The safety profile associated with Alunbrig from the ALTA-1L trial was generally consistent with the existing prescribing information, with no new safety concerns.

The trial was designed to assess the efficacy and safety of Alunbrig in comparison to crizotinib based on evaluation of the primary endpoint of PFS, or length of time from the start of treatment that a patient lives without the disease getting worse. Alunbrig is currently not approved as frontline therapy. The results from this interim analysis will be submitted for presentation at an upcoming medical meeting.

Comment: In May 2017 Alunbrig was granted accelerated approved by the FDA as a second-line therapy for adults with ALK positive NSCLC - roughly 5% of the total NSCLC patient population.