On October 6, 2026 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported that the FURVENT (NCT05607550) Phase 3 trial evaluating firmonertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations did not meet its primary endpoint of progression free survival (PFS) by blinded independent central review (BICR). Clinical benefit was observed with secondary endpoints such as PFS by investigator’s assessment and confirmed objective response rate by BICR. Although not yet mature, a trend toward an improvement in overall survival was also observed. The safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified.
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"These disappointing results are not what we hoped for, particularly for the patients with EGFR exon 20 insertion-mutant NSCLC who urgently need more effective treatment options," said Bing Yao, Ph.D., Chairman, Chief Executive Officer of ArriVent. "While the safety profile observed with firmonertinib was consistent with previous clinical studies, FURVENT did not show a meaningful improvement in PFS over chemotherapy by BICR in this study. We are deeply grateful to the patients, investigators and clinical teams who made this program possible and are evaluating the full FURVENT dataset as we determine the most appropriate development path for firmonertinib."
Key Results from the Phase 3 FURVENT Trial
The FURVENT key results are summarized below.
Firmonertinib
240mg
Median PFS
(months) Firmonertinib
160mg
Median PFS
(months) Control
Median
PFS
(months) p-value
(240mg vs.
control) HR (95%
CI)
240mg vs
Control HR (95%
CI)
160mg vs
Control Confirmed
ORR
240mg Confirmed
ORR
160mg Confirmed
ORR
control
BICR
11.0
months
8.4
months
9.5 months 0.0654
0.75
(0.55,
1.02)
0.91
(0.67, 1.25)
60% 35% 33%
Investigator’s Assessment
11.1
months
8.3
months
7.1
months
0.61
(0.46,
0.81)
0.86
(0.65,
1.14)
61% 41% 28%
The safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified. Treatment-emergent adverse events (TEAE) Grade ≥ 3 were 52% with firmonertinib 240mg, 53% with firmonertinib 160mg, and 55% with the control arm. Treatment-related adverse events (TRAE) Grade ≥ 3 were 26% with firmonertinib 240mg, 22% with firmonertinib 160mg, and 40% with the control arm.
About FURVENT
FURVENT (NCT05607550) is a global, pivotal 3 arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations being conducted jointly with our partner Allist. The FURVENT clinical trial is designed to assess the safety and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based chemotherapy with pemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per RECIST 1.1. Secondary endpoints include overall survival (OS), PFS by investigator’s assessment, confirmed objective response rate by BICR, and in patients with brain metastases at baseline, brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian countries including Japan and China.
About Firmonertinib
Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. Firmonertinib is approved in China for first-line advanced non-small-cell lung cancer (NSCLC) patients with EGFR exon 19 deletion or L858R mutations, with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, both known as EGFR classical mutations, as well as for with exon 20 insertion mutations who have experienced disease progression during or after platinum-containing chemotherapy, or who are intolerant to platinum-containing chemotherapy.
Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations.
Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 3 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA; NCT07185997).
About EGFR mutant NSCLC
Globally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations. PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of unmet medical need.
(Press release, ArriVent Biopharma, OCT 6, 2026, View Source [SID1234673210])