Core Insights - ArriVent BioPharma announced promising data from the Phase 1b FURTHER trial for firmonertinib in treating non-small cell lung cancer (NSCLC) with EGFR PACC mutations, highlighting a median progression-free survival (mPFS) of 16.0 months [2][3][6] - The company plans to initiate a pivotal Phase 3 study (ALPACCA) for first-line PACC patients in the second half of 2025 [3][13] Clinical Data Highlights - Firmonertinib demonstrated a median progression-free survival of 16.0 months with a 12.5-month follow-up, and a median duration of response of 14.6 months [6] - The overall response rate (ORR) was 68.2% at the 240 mg dose and 43.5% at the 160 mg dose, with confirmed responses observed in the majority of patients at the first tumor assessment [6] - In patients with CNS evaluable disease, there was a 41% confirmed complete response (CR) and a 53% confirmed overall response rate (ORR) [6] Safety Profile - Firmonertinib maintained a generally well-tolerated safety profile over a longer treatment duration, with the most frequent treatment-related adverse events being diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin [6][5] - The safety profile is consistent with the EGFR-TKI class and previous firmonertinib data [6][5] Development Plans - The company is advancing firmonertinib towards a registration study for EGFR PACC mutant NSCLC, with potential for accelerated approval [3] - The first patient enrollment in the ALPACCA Phase 3 trial is expected in the second half of 2025 [3][13] Company Overview - ArriVent BioPharma is focused on developing innovative biopharmaceutical therapeutics to address unmet medical needs in cancer treatment [7] - Firmonertinib is an oral, highly brain-penetrant EGFR inhibitor effective against both classical and uncommon EGFR mutations, including PACC mutations [8]