other material
confidence high
sentiment positive
materiality 0.60
ArriVent firmonertinib FURTHER Phase 1b data published in Cancer Cell: ORR 43-68% in EGFR PACC NSCLC
ArriVent BioPharma, Inc.
- Confirmed ORR 43% at 160 mg and 68% at 240 mg, with median PFS of 11.1 and 16.0 months by BICR in front-line EGFR PACC-mutant NSCLC.
- Intracranial ORR of 47% (8/17), including 41% complete responses, among 17 patients with baseline brain metastases.
- 80% of evaluable patients achieved complete ctDNA molecular response by cycle 3; those patients showed ORR 70% vs 20% and PFS 15.1 vs 3.0 months.
- EGFR PACC mutations are ~12% of EGFR-mutant tumors with no established targeted standard of care; firmonertinib showed enhanced in vitro potency vs osimertinib.
- Global Phase 3 ALPACCA trial (FURMO-006; NCT07185997) is enrolling, testing firmonertinib vs investigator's choice of osimertinib or afatinib in first-line disease.