Arrivent Presents the Final Analysis of Firmonertinib Monotherapy Data from Global Phase 1b Study in EGFR PACC Mutant Non-Small Cell Lung Cancer at the 2025 World Conference on Lung Cancer

Core Insights - ArriVent BioPharma, Inc. presented positive final proof-of-concept data for firmonertinib in treating non-small cell lung cancer (NSCLC) with EGFR PACC mutations at the IASCLC 2025 conference [1][2] Summary by Category Clinical Data - Firmonertinib demonstrated a median progression-free survival (mPFS) of 16.0 months in first-line patients, with a confirmed overall response rate (cORR) of 68.2% and a duration of response (DOR) of 14.6 months [5][6] - CNS responses included a confirmed overall response rate of 42.9% and complete responses of 35.7% in CNS evaluable patients [6] - Rapid clearance of PACC circulating tumor DNA (ctDNA) was observed, with 82% clearance in patients treated with 240 mg and 79% clearance in those treated with 160 mg [6] Safety Profile - The safety profile of firmonertinib remained consistent with no new safety signals reported, and the most common treatment-related adverse events included diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin [4][6] Future Developments - The company plans to enroll the first patient in the global pivotal Phase 3 ALPACCA study for first-line EGFR PACC mutant NSCLC patients in the second half of 2025 [5][6] - Firmonertinib is also being studied in a global Phase 3 trial for patients with EGFR exon 20 insertion mutations [10]