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ArriVent Announces Cancer Cell Publication Highlighting Firmonertinib in EGFR PACC-Mutant Non-Small Cell Lung Cancer

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  • ArriVent BioPharma published Phase 1b FURMO-002 results for firmonertinib in Cancer Cell, highlighting its potential as the first oral, chemotherapy-free targeted therapy for treatment-naïve patients with advanced EGFR PACC-mutant NSCLC.
  • Firmonertinib demonstrated enhanced in vitro potency vs. osimertinib due to its unique trifluoroethoxy side chain creating additional binding contact points for PACC-mutated EGFR.
  • Clinical data showed robust activity with 43% confirmed overall response rate (ORR) at 160 mg & 68% at 240 mg, alongside median progression-free survival (PFS) of 11.1 months & 16.0 months respectively.
  • The drug exhibited meaningful intracranial activity with a 47% confirmed intracranial ORR & 41% complete responses among 17 patients with baseline brain metastases.
  • ctDNA clearance correlated with improved outcomes, as 80% of evaluable patients achieved complete molecular response by cycle 3, resulting in higher ORR (70% vs. 20%) & longer median PFS (15.1 vs. 3.0 months).
  • Firmonertinib maintained a manageable & consistent safety profile with treatment-related adverse event rates consistent with prior studies.
  • ArriVent is evaluating firmonertinib vs. investigator's choice of osimertinib or afatinib as first-line treatment in the ongoing global Phase 3 ALPACCA trial (NCT07185997).
  • Firmonertinib is currently approved in China for first-line NSCLC with classical EGFR mutations (exon 19 deletion or L858R), previously treated NSCLC with T790M mutation, & EGFR exon 20 insertion mutations.
  • The drug holds FDA Breakthrough Therapy Designation for untreated EGFR exon 20 insertion NSCLC & FDA Orphan Drug Designation for NSCLC with EGFR, HER2, or HER4 mutations.
  • EGFR PACC mutations represent approximately 12% of EGFR-mutant tumors & currently lack an established targeted standard of care.