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

• 16.0 months median progression free survival (mPFS) with firmonertinib 240 mg by blinded independent central review (BICR) in first-line patients
• Confirmed overall response rate (cORR) 68.2% and duration of response (DOR) 14.6 months by BICR in first-line patients
• Confirmed CNS (central nervous system) responses with firmonertinib including complete responses (CRs) by BICR
• Firmonertinib rapidly decreased or cleared PACC circulating tumor DNA (ctDNA) in frontline patients across PACC mutation types (frequent, less frequent and compound PACC) consistent with broad PACC activity
• Enrollment of the first patient in the global pivotal Phase 3 ALPACCA study in first-line EGFR PACC mutant non-small cell lung (NSCLC) cancer expected in the second half of 2025

Excerpt from the Press Release:

NEWTOWN SQUARE, Pa., Sept. 09, 2025 (GLOBE NEWSWIRE) — ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today presented positive final 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 (NSCLC) harboring EGFR PACC mutations at the IASCLC 2025 annual World Conference on Lung Cancer (WCLC), in Barcelona, Spain.

“Our 16-month prolonged progression free survival with once daily oral firmonertinib monotherapy has been maintained with 16.5 months of median follow up and we are particularly encouraged by the CNS responses including CNS complete responses” said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. “Together this data reinforces the potential of firmonertinib to address key unmet needs in the global EGFR mutant NSCLC treatment landscape. Additionally, the rapid clearance of PACC ctDNA in frontline patients observed across a broad range of PACC mutations, including those with frequent, less frequent and compound PACC mutations, is consistent with the broad activity of firmonertinib in PACC mutant NSCLC. We expect to enroll the first patient in our global registrational ALPACCA Phase 3 trial in frontline PACC patients in the second half of the year.”

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