other material
confidence high
sentiment negative
materiality 0.85
ArriVent's Phase 3 FURVENT trial misses primary PFS endpoint; firmonertinib 240mg PFS 11.0 vs 9.5 months (p=0.0654)
ArriVent BioPharma, Inc.
- FURVENT Phase 3 trial of firmonertinib in first-line EGFR exon 20 insertion NSCLC missed primary endpoint of PFS by BICR: 240mg 11.0 months vs control 9.5 months, p=0.0654, HR 0.75.
- 160mg arm median PFS 8.4 months, HR 0.91; investigator-assessed PFS 11.1 vs 8.3 vs 7.1 months, HR 0.61 (0.46, 0.81) for 240mg vs control.
- Confirmed ORR by BICR: 60% for firmonertinib 240mg, 35% for 160mg, 33% for control; investigator-assessed ORR 61%, 41%, 28%.
- Safety consistent with prior studies, no new signals; Grade >=3 TEAEs 52% (240mg), 53% (160mg), 55% (control); Grade >=3 TRAEs 26%, 22%, 40%.
- CEO Bing Yao called the results 'disappointing'; ArriVent says it is evaluating the full FURVENT dataset to determine the most appropriate development path for firmonertinib.