ArriVent Biopharma announces interim firmonertinib data from Phase 1b study

ArriVent BioPharma (AVBP) announced additional follow up proof-of-concept data from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with non-small cell lung cancer harboring EGFR PACC mutations and a clinical development update for the firmonertinib program for the treatment of EGFR PACC mutant NSCLC. ArriVent plans to host a virtual webinar on June 23, 2025 at 8 am ET. Key Highlights of Interim Data: Clinically Meaningful Progression Free Survival and Durable Responses; 16.0 months mPFS with firmonertinib 240 mg by BICR with 12.5 months median follow up; Majority of patients treated at 240 mg remain on study after 1 year; 14.6 months median duration of response with firmonertinib 240 mg by BICR; 68.2% and 43.5% confirmed ORR by BICR at 240mg and 160mg dose levels, respectively; Confirmed responses at first tumor assessment in the majority of patients; 41% CNS confirmed CR and 53% CNS confirmed ORR in CNS evaluable disease patients by BICR; Consistent Safety Profile with No New Safety Signals; Generally well-tolerated and manageable safety profile maintained over longer treatment duration; Most frequent treatment-related adverse events include diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin; Safety profile consistent with EGFR-TKI class and initial firmonertinib Phase1b PACC and FURTHER data. Development Update – Firmonertinib for the Treatment of EGFR PACC Mutations: ALPACCA, the first randomized global Phase 3 study in first-line NSCLC in patients across PACC mutations designed with extensive regulatory input; Trial design enables potential for both accelerated and full approval; Firmonertinib 240 mg selected as the optimal dose for pivotal Phase 3 development;Enrollment of first patient in ALPACCA is expected in the second half of 2025