ArriVent Announces Program Update from the Phase 3 FURVENT Trial of Firmonertinib in First-Line EGFR Exon 20 Insertion Mutant NSCLC

Independent review and investigator assessments gave different progression-free survival results; the development path remains under evaluation.

Rhea-AI Summary

ArriVent BioPharma (AVBP) announced that its Phase 3 FURVENT trial of firmonertinib in previously untreated lung cancer missed its primary endpoint.

The trial enrolled patients with locally advanced or metastatic non-squamous non-small cell lung cancer carrying EGFR exon 20 insertion mutations. Median progression-free survival, time without cancer worsening, by blinded independent central review was 11.0 months at 240mg and 8.4 months at 160mg, versus 9.5 months with control; the 240mg comparison had a p-value of 0.0654. Confirmed response rates by independent review were 60%, 35% and 33%, respectively. Investigator-assessed median progression-free survival was 11.1, 8.3 and 7.1 months, respectively.

ArriVent reported an improvement trend in overall survival, but those data are not yet mature. No new safety signals were identified. The company is evaluating the full dataset to determine firmonertinib's development path.

8 points · 0 major

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Rhea-AI Sentiment measures something else, the tone of the wording.

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1 major · 3 points

How the balance works

Positive

• Moderate pointIndependent-review response rates were 60% at 240mg and 35% at 160mg, versus 33% with control.
• Moderate pointInvestigator-assessed median progression-free survival at 240mg was 11.1 months versus 7.1 with control; hazard ratio 0.61 (95% CI: 0.46–0.81).
• Moderate pointInvestigator-assessed response rates were 61% at 240mg and 41% at 160mg, versus 28% with control.
• Minor pointInvestigator-assessed median progression-free survival at 160mg was 8.3 months versus 7.1 with control; hazard ratio 0.86 (95% CI: 0.65–1.14).
• Minor pointOverall survival showed an improvement trend, although the data are not yet mature.

3 minor points

• Minor pointSafety remained consistent with previous firmonertinib studies, with no new safety signals identified.
• Minor pointGrade ≥3 treatment-emergent adverse events were 52% at 240mg and 53% at 160mg, versus 55% with control.
• Minor pointGrade ≥3 treatment-related adverse events were 26% at 240mg and 22% at 160mg, versus 40% with control.

Negative

• Major pointFURVENT missed its primary endpoint; independent-review median progression-free survival at 240mg was 11.0 versus 9.5 months with control.
• Minor pointThe 240mg primary-endpoint comparison had p=0.0654; hazard ratio was 0.75 (95% CI: 0.55–1.02).
• Minor pointIndependent-review median progression-free survival at 160mg was 8.4 versus 9.5 months with control; hazard ratio 0.91 (95% CI: 0.67–1.25).

News Explained

The safety breakdown reports grade 3 or higher treatment-emergent adverse events in 52% and 53% of the firmonertinib 240mg and 160mg groups, versus 55% with control; treatment-related grade 3 or higher events were 26% and 22%, versus 40% with control.

Key Figures

Median PFS, firmonertinib 240mg: 11.0 months Median PFS, firmonertinib 160mg: 8.4 months Median PFS, control: 9.5 months +4 more

Median PFS, firmonertinib 240mg

11.0 months

FURVENT, BICR assessment; primary endpoint not met

Median PFS, firmonertinib 160mg

8.4 months

FURVENT, BICR assessment; primary endpoint not met

Median PFS, control

9.5 months

FURVENT, BICR assessment

PFS p-value

0.0654

Firmonertinib 240mg vs. control, BICR assessment; primary endpoint not met

Confirmed ORR, firmonertinib 240mg

60%

FURVENT, BICR assessment

Confirmed ORR, firmonertinib 160mg

35%

FURVENT, BICR assessment

Confirmed ORR, control

33%

FURVENT, BICR assessment

Key Terms

progression free survival, blinded independent central review, objective response rate, treatment-emergent adverse events, +1 more

5 terms

progression free survival medical

"primary endpoint of progression free survival (PFS) by blinded independent"

Progression free survival is the length of time during and after a treatment when a disease, such as cancer, does not get worse or spread. It is an important measure because longer periods of stability can indicate that a treatment is effectively controlling the condition. For investors, it provides insight into the potential durability and success of a therapy or medication.

blinded independent central review medical

"progression free survival (PFS) by blinded independent central review (BICR)"

Blinded independent central review is a quality-control step in clinical trials where outside medical experts, who do not know which patients received the experimental therapy, re-examine key measurements (like scans or lab results) to prevent bias. Think of it as neutral referees watching game footage without knowing the teams, which gives investors greater confidence that the trial results are fair, more reliable for regulators, and less likely to be overturned or disputed.

objective response rate medical

"confirmed objective response rate by BICR"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

treatment-emergent adverse events medical

"Treatment-emergent adverse events (TEAE) Grade ≥ 3"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

treatment-related adverse events medical

"Treatment-related adverse events (TRAE) Grade ≥ 3"

Treatment-related adverse events are harmful or unwanted health effects that doctors or regulators determine were caused by a drug, vaccine, device, or other medical therapy. Investors care because how often and how severe these side effects are can shape regulatory approval, labeling, sales potential and legal risk — similar to how product defects can stop or damage a company's ability to sell an item.

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NEWTOWN SQUARE, Pa., Oct. 06, 2026 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced 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.

“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.

About ArriVent
ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our business strategy, our plans, our evaluation of the full FURVENT dataset, and our determination of the appropriate development path for firmonertinib, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission on March 5, 2026 and our other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law.

Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com

FAQ

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Did ArriVent's Phase 3 FURVENT trial meet its primary endpoint?

FURVENT did not meet its primary endpoint of progression-free survival by blinded independent central review. Median progression-free survival was 11.0 months with firmonertinib 240mg, 8.4 months with 160mg and 9.5 months with control. The 240mg-versus-control p-value was 0.0654.

What safety results did ArriVent report from FURVENT?

FURVENT identified no new safety signals, with safety consistent with previous firmonertinib studies. Grade ≥3 treatment-emergent adverse events occurred in 52%, 53% and 55% of the 240mg, 160mg and control arms, respectively. Grade ≥3 treatment-related adverse events occurred in 26%, 22% and 40%, respectively.