ArriVent Announces First Patient Dosed in Global Pivotal Phase 3 ALPACCA Trial Evaluating Firmonertinib for First-Line Treatment of EGFR PACC Mutant Non-Small Cell Lung Cancer

Core Insights - ArriVent BioPharma has initiated the global pivotal Phase 3 ALPACCA study for firmonertinib, targeting first-line treatment of EGFR PACC mutant non-small cell lung cancer (NSCLC) [1][2] - Firmonertinib is positioned to address a significant unmet medical need in patients with EGFR PACC mutations, who currently have limited treatment options [2][10] - The ALPACCA study aims to evaluate firmonertinib against osimertinib or afatinib, with primary endpoints including overall response rate (ORR) and progression-free survival (PFS) [2][8] Company Overview - ArriVent is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer patients [3] - The company aims to leverage its expertise in drug development to maximize the potential of firmonertinib and advance its therapeutic pipeline [3] Product Details - Firmonertinib is an oral, mutation-selective EGFR inhibitor effective against both classical and uncommon EGFR mutations, including PACC mutations [4][5] - The drug has previously received FDA Breakthrough Therapy Designation and Orphan Drug Designation for specific NSCLC patient populations [5] Clinical Study Insights - The ALPACCA study is designed to support potential global registration and includes an estimated 42,000 annual NSCLC patients with EGFR PACC mutations globally, with about 6,200 in the US [2][9] - Firmonertinib's pivotal development is based on previous trial data showing a 16-month median PFS and a 68% confirmed ORR [2][8] Market Context - NSCLC accounts for approximately 85% of all lung cancer cases, with EGFR mutations being a common early event in its development [9] - PACC mutations represent about 12% of all EGFR mutations, highlighting a significant area of unmet medical need due to poor treatment outcomes [9][10]