ArriVent Announces First Patient Dosed in Global Pivotal Phase 3 ALPACCA Trial Evaluating Firmonertinib for First-Line Treatment of EGFR PACC Mutant Non-Small Cell Lung Cancer

Rhea-AI Summary

ArriVent BioPharma (Nasdaq: AVBP) announced on Dec. 22, 2025 that the first patient was dosed in the global pivotal Phase 3 ALPACCA (FURMO-006) study evaluating once-daily oral firmonertinib 240 mg as first-line treatment for EGFR PACC mutant non-small cell lung cancer.

The randomized trial compares firmonertinib to investigator’s choice of osimertinib or afatinib, with primary endpoints of overall response rate (ORR) and progression-free survival (PFS) by blinded independent central review. Dose selection was based on prior data showing 16-month median PFS and a 68% confirmed ORR in the FURTHER trial. The study is designed to support potential accelerated and full regulatory approvals. Estimated annual incidence: ~42,000 global ex-China and ~6,200 US patients.

Positive

• First patient dosed in global pivotal Phase 3 ALPACCA
• 16-month median PFS observed in prior FURTHER trial
• 68% confirmed ORR by BICR reported in FURTHER

Negative

• Not yet approved; approval depends on ALPACCA outcomes
• Comparator arm uses osimertinib or afatinib, raising bar for superiority

Key Figures

Firmonertinib dose 240 mg once daily Dose selected for pivotal ALPACCA Phase 3 trial

Median PFS 16 months Phase 1b FURTHER trial at 240 mg by BICR

Overall response rate 68% ORR Confirmed ORR in FURTHER Phase 1b at 240 mg by BICR

Primary endpoints ORR and PFS Co-primary endpoints in ALPACCA Phase 3 by BICR

Global incidence 42,000 patients/year Estimated ex-China annual EGFR PACC mutant NSCLC incidence

US incidence 6,200 patients/year Estimated annual US EGFR PACC mutant NSCLC incidence

Market Reality Check

$22.40 Last Close

Volume Volume 863,092 is 1.81x the 20-day average of 476,342, indicating elevated interest ahead of this update. high

Technical Shares trade above the 200-day MA of 20.35 at a pre-news level of 22.065, reflecting an established uptrend.

Peers on Argus

AVBP showed a pre-news gain of 3.97% while peers were mixed: DAWN down 7.23%, KURA down 1.18%, TNGX up 0.83%, IMNM up 3.52%, PRAX up 0.47%, suggesting a company-specific driver rather than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 10	Q3 earnings & pipeline	Positive	+3.1%	Reported strong cash of $305.4M and clear clinical milestones for firmonertinib.
Sep 22	Executive hire	Positive	-1.9%	Named an experienced Chief Commercial Officer ahead of potential firmonertinib launch.
Sep 09	Phase 1b final data	Positive	-1.9%	Presented strong Phase 1b efficacy and CNS activity for firmonertinib at 240 mg.
Aug 11	Q2 earnings & pipeline	Negative	-3.3%	Reported larger net loss driven by higher R&D and upfront payment obligations.
Jul 01	Equity offering	Negative	+1.0%	Announced ~$75M equity and pre-funded warrant offering to support firmonertinib and pipeline.

Pattern Detected

Positive clinical and strategic news has not consistently translated into gains; several prior upbeat trial and corporate updates saw negative or muted next-day reactions.

Recent Company History

Over the last six months, ArriVent advanced firmonertinib and strengthened its balance sheet. A Jun 23 clinical update on Phase 1b data showed strong efficacy but was followed by a -9.6% move. Subsequent Q2 and Q3 earnings on Aug 11 and Nov 10 highlighted substantial cash balances and progress toward pivotal studies, with mixed share reactions. A July offering raised about $75M to fund development. The new ALPACCA Phase 3 first-patient-dosed milestone fits the ongoing transition toward late-stage, registration-directed trials.

Market Pulse Summary

This announcement marks first patient dosed in the pivotal ALPACCA Phase 3 trial of firmonertinib for EGFR PACC mutant NSCLC, building directly on prior Phase 1b data showing 16-month PFS and 68% ORR at 240 mg. The trial is structured to support both accelerated and full approvals in a defined population with an estimated 42,000 ex-China and 6,200 US patients annually. Investors may track enrollment progress, BICR-assessed endpoints, and ongoing funding from prior capital raises and reported cash balances.

Key Terms

phase 3 medical

"the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

overall response rate (orr) medical

"The primary endpoints are overall response rate (ORR) and progression-free survival"

Overall response rate (ORR) is the percentage of trial participants whose disease measurably improves—typically tumor shrinkage or disappearance—according to predefined medical criteria. Investors watch ORR because it provides an early, concrete signal of a therapy’s effectiveness and commercial potential, similar to seeing what share of products in a test batch actually work before deciding to back wider production.

progression-free survival (pfs) medical

"The primary endpoints are overall response rate (ORR) and progression-free survival (PFS)"

Progression-free survival (PFS) measures the length of time in a clinical trial or treatment period during which a patient’s disease does not get worse. Investors watch PFS because longer PFS in trials can signal a drug’s effectiveness, influence regulatory approval and reimbursement decisions, and affect commercial value—think of it as how long a product keeps a problem from returning, which helps estimate future sales and competitive advantage.

blinded independent central review (bicr) medical

"PFS) by blinded independent central review (BICR). The 240 mg dose"

A blinded independent central review (BICR) is a process in clinical trials where outside experts, who do not know which patients received the experimental treatment, centrally re-check key medical data (often images or test results) to confirm outcomes. Investors care because BICR reduces bias and disagreement in trial results—think of neutral referees reviewing game footage without team colors—so findings are more credible for regulators, partners and valuation decisions.

central nervous system (cns) medical

"systemic and central nervous system (CNS) activity in patients, we believe"

The central nervous system (CNS) is the part of the body that includes the brain and spinal cord, acting as the control center for processing information and directing actions. It is essential for coordinating all bodily functions, from movement to thinking. For investors, understanding the CNS is important because it illustrates how complex systems—like markets or organizations—rely on core components to operate smoothly.

circulating tumor dna medical

"rapid clearance of PACC circulating tumor DNA in 82% of frontline"

Fragments of DNA shed by cancer cells into the bloodstream that act like tiny fingerprints of a tumor; they can be detected with a blood test rather than a biopsy. Investors care because circulating tumor DNA (ctDNA) enables faster, lower-cost ways to detect disease, track treatment response, identify emerging resistance and enroll patients in trials—factors that can materially affect the commercial prospects of diagnostics and therapeutics.

AI-generated analysis. Not financial advice.

• Firmonertinib has the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapy
• ALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals

NEWTOWN SQUARE, Pa., Dec. 22, 2025 (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 first patient has been dosed in the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy for first-line treatment of EGFR PACC mutant non-small cell lung cancer (NSCLC). Firmonertinib is an oral, once daily, highly brain-penetrant and broadly active mutation-selective EGFR inhibitor.

“Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib,” said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. “Patients with EGFR PACC mutant NSCLC currently have limited treatment options and represent a clear unmet medical need. With a well-characterized safety profile and broad clinical systemic and central nervous system (CNS) activity in patients, we believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations and the potential to become a cornerstone therapy across the EGFR mutant spectrum.”

PACC mutations represent a distinct and underserved population of EGFR mutant NSCLC, with limited approved first-line targeted therapies and historically poor outcomes. The ALPACCA (FURMO-006) randomized, global Phase 3 study is evaluating firmonertinib 240 mg once daily versus investigator’s choice of osimertinib or afatinib in first-line patients with EGFR PACC mutant NSCLC. The primary endpoints are overall response rate (ORR) and progression-free survival (PFS) by blinded independent central review (BICR). The 240 mg dose of firmonertinib was selected for pivotal development based on compelling data showing a 16-month median PFS and a confirmed 68% ORR by BICR in the FURTHER trial. The ALPACCA study is designed to support potential global registration with endpoints for accelerated and full approval pathways. We estimate that the global ex-China annual incidence of NSCLC patients with EGFR PACC mutations to be approximately 42,000 patients and the US annual incidence to be approximately 6,200 patients.

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.

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. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations.

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).

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 EGFR PACC mutations

P-loop and αC-helix compressing (PACC) EGFR mutations are a distinct set of approximately 70 mostly missense activating mutations within the kinase domain of EGFR. They are similar to Exon 20 insertion mutations in narrowing the drug binding pocket to affect tyrosine kinase inhibitor activity. PACC mutations are diagnosed through commercially available NGS and most PCR tests. Patients with PACC mutations have limited treatment options, and there is no broadly utilized standard of care treatment for first-line PACC mutant patients.

About FURVENT

FURVENT 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Secondary endpoints in patients with brain metastases at baseline include 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. An interim analysis for this study has not been performed and there is no plan to perform such analysis given the expected timing of top-line data.

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 future results of operations or financial condition, business strategy and plans, estimates of our addressable market, activity of firmonertinib compared to available therapies, anticipated clinical milestones, our expectation that ALPACCA may support potential global registration and may facilitate accelerated and full approval pathways, and objectives of management for future operations, 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, 2024, filed with the Securities and Exchange Commission on March 3, 2025 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

What did ArriVent announce about firmonertinib on December 22, 2025 (AVBP)?

ArriVent announced the first patient dosing in the global pivotal Phase 3 ALPACCA trial of firmonertinib 240 mg for first-line EGFR PACC mutant NSCLC.

What are the primary endpoints of the ALPACCA Phase 3 trial (AVBP)?

The primary endpoints are overall response rate (ORR) and progression-free survival (PFS) assessed by blinded independent central review.

What prior efficacy supported the 240 mg firmonertinib dose in ALPACCA (AVBP)?

Dose selection was based on FURTHER trial data showing a 16-month median PFS and a 68% confirmed ORR by BICR.

Who is firmonertinib being compared against in ALPACCA (AVBP)?

ALPACCA randomizes firmonertinib versus investigator’s choice of osimertinib or afatinib in first-line EGFR PACC mutant NSCLC.

What regulatory pathways does ALPACCA support for firmonertinib (AVBP)?

The study is designed to support potential accelerated and full global regulatory approval pathways.

How large is the target patient population for EGFR PACC mutant NSCLC (AVBP)?

ArriVent estimates the annual incidence at approximately 42,000 patients globally ex-China and 6,200 patients in the US.