CHMP positive for Alunbrig to treat patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer.- Takeda

Takeda Pharmaceutical Company Limited announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of Alunbrig (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Alunbrig is a tyrosine kinase inhibitor (TKI) designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approves Alunbrig, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food.

The randomized, global Phase II ALTA trial was designed to investigate the efficacy and safety of Alunbrig in patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib. Patients were randomized to receive one of two regimens of Alunbrig: 90 mg of Alunbrig once daily (n=112) or 180 mg once daily with seven-day lead-in at 90 mg once daily (n=110). "The ALTA trial has established Alunbrig as a potential second-line treatment option for ALK+ NSCLC, by demonstrating significant efficacy with a manageable safety profile," said Jes�s G�mez-Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda. "With 16.7 months median progression-free survival, the longest of any ALK inhibitor to be reported in this setting, Alunbrig offers great potential for patients who progressed on crizotinib.

As part of this submission, the CHMP also reviewed data from the first interim analysis of the Phase III ALTA-1L trial, which met its primary endpoint, as supportive evidence. In ALTA-1L, treatment with Alunbrig resulted in a statistically and clinically significant improvement in PFS versus crizotinib as assessed by a blinded independent review committee. The safety profile associated with Alunbrig was generally consistent with prior studies and approved U.S. and Canadian labeling.