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Takeda Announces Phase 3 Trial of ALUNBRIG® (brigatinib) Met Primary Endpoint Demonstrating Superiority in Progression-Free Survival Versus Crizotinib in Patients with ALK+ Advanced NSCLC Who are ALK Inhibitor Naïve

(Morningstar) July 25, 2018 - Takeda Pharmaceutical Company Limited today announced that the global, randomized, Phase 3 ALTA-1L (ALK in Lung Cancer Trial of AP26113 in 1 st 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 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 Jesús Gomez-Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda.

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H. Jack West, MD (Posted: July 25, 2018)

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Nice to see, though not surprising. Brigatinib is a very good second generation ALK inhibitor, at least comparable to if not more efficacious than alectinib, which crushed crizotinib in the ALEX trial that was a head to head comparison of the two. The real question is whether brigatinib will look like a lateral move or possibly meaningfully better than alectinib when we're left to do our cross-trial comparison of ALTA-1 results to those from ALEX.

We'll look forward to seeing the actual results in one of the fall meetings -- not sure if that will be WCLC in Toronto or at ESMO in Munich.

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