Takeda Pharmaceutical says Phase 3 Alunbrig trial met primary endpoint
Takeda Pharmaceutical announced that the global, randomized, Phase 3 ALTA-1L trial met its primary endpoint at the first pre-specified interim analysis, with ALUNBRIG demonstrating a statistically significant improvement in progression-free survival compared to crizotinib in adults with anaplastic lymphoma kinase-positive locally advanced or metastatic non-small cell lung cancer who had not received a prior ALK inhibitor. 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. "This represents a major milestone for the ALUNBRIG program. Our goal with ALUNBRIG is to improve the lives of patients with ALK+ NSCLC by furthering the available therapeutic options," said Jesus Gomez-Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda. "We are encouraged by the data, which demonstrated a statistically significant improvement in progression-free survival versus crizotinib in patients with ALK+ advanced NSCLC, and look forward to beginning discussions with regulatory authorities as we seek to expand ALUNBRIG's indication into the frontline setting." The safety profile associated with ALUNBRIG from the ALTA-1L trial was generally consistent with the existing prescribing information, with no new safety concerns.