On September 9, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported 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 (Press release, ArriVent Biopharma, SEP 9, 2025, View Source [SID1234655873]).

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"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."

Key Highlights of Longer-term Final Analysis Data for Firmonertinib Monotherapy:

● Maintained Clinically Meaningful PFS and Durable Responses
o 16.0 months mPFS with firmonertinib once daily 240 mg by BICR, with majority of patients remaining on study
o 14.6 months median duration of response with firmonertinib 240 mg by BICR
o 68.2% and 43.5% confirmed ORR by BICR at 240 mg and 160 mg, respectively
◾ Confirmed responses at first tumor assessment in the majority of patients
◾ Responses across a wide range of EGFR PACC mutations including most frequent (G719X, S768I), less frequent (E709X, V774M) and compound mutations

o 42.9% (6/14) CNS confirmed ORR and 35.7% (5/14) CNS confirmed CRs in CNS evaluable disease front-line patients by BICR

● Safety Profile Continues to be Consistent with No New Safety Signals
o Generally well-tolerated and manageable safety profile maintained over longer treatment duration
o Most frequent treatment-related adverse events include diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin
o No new safety findings with further follow up and safety profile remains consistent with EGFR-TKI class

● Rapidly Decreased or Cleared PACC ctDNA in Frontline Patients
o 82% (9/11) and 79% (11/14) ctDNA clearance in frontline PACC patients treated with firmonertinib at 240 mg and 160 mg, respectively, in patients with detectable PACC ctDNA at baseline
o Consistent decreases in ctDNA across different PACC mutations were observed including in patients with frequent, less frequent and compound mutations