ArriVent's FURVENT Phase 3 trial misses PFS endpoint in EGFR exon 20 NSCLC

ArriVent BioPharma announced on October 6, 2026 that its Phase 3 FURVENT trial (NCT05607550) of firmonertinib in first-line EGFR exon 20 insertion mutant non-small cell lung cancer did not meet its primary endpoint of progression free survival by blinded independent central review.¹

By BICR, median PFS was 11.0 months for the 240mg firmonertinib dose and 8.4 months for the 160mg dose, compared with 9.5 months for the control arm, with a p-value of 0.0654 for the 240mg dose versus control and hazard ratios of 0.75 and 0.91 for the 240mg and 160mg doses respectively.¹ Confirmed objective response rates by BICR were 60% for the 240mg dose, 35% for the 160mg dose, and 33% for the control arm.¹

Despite the missed primary endpoint, the company said secondary measures including investigator-assessed PFS and confirmed response rate by BICR showed benefit, and although not mature, there was a trend toward improved overall survival.¹ The safety profile was described as consistent with prior firmonertinib studies, with no new safety signals.¹

Grade 3 or higher treatment-emergent adverse events occurred in 52% of patients on the 240mg dose, 53% on the 160mg dose, and 55% in the control arm.¹ Treatment-related adverse events of grade 3 or higher occurred in 26% of the 240mg group, 22% of the 160mg group, and 40% of the control arm.¹

CEO Bing Yao said the results were disappointing, particularly for patients with EGFR exon 20 insertion-mutant NSCLC who need more effective treatments.¹ He added that firmonertinib's safety profile matched earlier studies, but FURVENT did not show a meaningful PFS improvement over chemotherapy by BICR.¹ ArriVent said it is evaluating the full FURVENT dataset to determine the most appropriate development path for firmonertinib.¹

The trial, conducted jointly with partner Allist, enrolled 398 patients globally, including sites in the United States, Europe, Japan and China.¹