ArriVent BioPharma's Phase 3 lung cancer trial misses primary endpoint, shares tumble

ArriVent BioPharma reported that its investigational EGFR tyrosine kinase inhibitor firmonertinib did not achieve a statistically significant improvement in progression-free survival in the Phase 3 FURVENT trial for patients with advanced non-squamous NSCLC harboring EGFR exon 20 insertion mutations.

The trial enrolled about 400 patients and showed a median PFS of 11 months for firmonertinib versus 9.5 months for standard chemotherapy, a difference that did not meet the pre-specified significance threshold.

Analysts said the result was largely driven by unexpectedly strong outcomes in the chemotherapy control arm, leading to a sharp decline in ArriVent's share price, wiping out roughly half of its market value.

Investors are now shifting attention to the company's ongoing late-stage study of the same inhibitor in a different lung-cancer indication and to its antibody-drug conjugate pipeline.