Furmonertinib - (FURVENT)

Oct. 6, 2026: ArriVent BioPharma (NASDAQ: AVBP) reported that the Phase 3 FURVENT trial (NCT05607550) of firmonertinib monotherapy in previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations failed its primary endpoint of PFS by blinded independent central review.

By BICR, median PFS was 11.0 months for firmonertinib 240 mg, 8.4 months for 160 mg, and 9.5 months for control; the 240 mg vs control comparison had p=0.0654 and HR 0.75 (95% CI, 0.55-1.02), while 160 mg vs control had HR 0.91 (0.67-1.25). Confirmed ORR by BICR was 60% for 240 mg, 35% for 160 mg, and 33% for control.

Secondary endpoints showed clinical benefit, including investigator-assessed PFS of 11.1 months (240 mg), 8.3 months (160 mg), and 7.1 months (control), with HR 0.61 (0.46-0.81) for 240 mg vs control and 0.86 (0.65-1.14) for 160 mg vs control; investigator-assessed ORR was 61%, 41%, and 28%, respectively. Overall survival was not mature, though a trend toward improvement was observed. Safety was consistent with prior studies, with no new safety signals; Grade ≥3 TEAEs were 52%, 53%, and 55% across the three arms. ArriVent said it is evaluating the full dataset to determine the development path for firmonertinib.