ArriVent to Present Proof-Of-Concept Phase 1b Data for Firmonertinib in EGFR PACC Mutant Non-Small Cell Lung Cancer at the 2024 World Conference on Lung Cancer

Rhea-AI Summary

ArriVent BioPharma (Nasdaq: AVBP) will present interim randomized Phase 1b FURTHER data for first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations at the 2024 World Conference on Lung Cancer (WCLC). The presentation, selected for the Presidential Symposium, marks the first prospectively designed randomized clinical data for a small-molecule EGFR tyrosine kinase inhibitor in this specific patient population. The study, titled 'FURTHER: A Global, Randomized study of Firmonertinib at Two Dose Levels in TKI-Naive, Advanced NSCLC with EGFR PACC Mutations,' will be presented on September 9, 2024. ArriVent will also host a virtual webinar on the firmonertinib program on the same day at 4:30pm ET.

Positive

• First prospectively designed randomized clinical data for EGFR tyrosine kinase inhibitor in PACC mutant NSCLC
• Presentation selected for Presidential Symposium at major lung cancer conference
• Study focuses on first-line monotherapy, potentially addressing an unmet medical need

Negative

• Only interim data available, full results not yet disclosed
• Efficacy and safety outcomes not mentioned in the press release

First-line monotherapy data for once daily firmonertinib selected as an oral presentation in the presidential session

      First prospectively designed randomized clinical data for a small-molecule EGFR tyrosine kinase inhibitor in PACC mutant non-small cell lung cancer patient population

      ArriVent to host virtual webinar in conjunction with 2024 WCLC

NEWTOWN SQUARE, Pa., Aug. 12, 2024 (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 it will present interim randomized Phase 1b FURTHER data for first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations as a Presidential Symposium Presentation at the 2024 annual World Conference on Lung Cancer (WCLC) taking place September 7-10, 2024, in San Diego, California. ArriVent plans to host a virtual webinar on the firmonertinib program on September 9, 2024 at 4:30pm ET in conjunction with 2024 WCLC.

Presidential Symposium Presentation Details
FURTHER: A global, randomized study of Firmonertinib at two dose levels in TKI-naive, advanced NSCLC with EGFR PACC mutations
Abstract Title: FURTHER: A Global, Randomized study of Firmonertinib at Two Dose Levels in TKI-Naive, Advanced NSCLC with EGFR PACC Mutations
Date and Time: Monday, September 9, 2024, 8:58am – 9:05am PT
Session: PL04 - Presidential Symposium 2
Location: San Diego, CA

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 (formerly furmonertinib) 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 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. Food and Drug Administration Orphan Drug Designation for the treatment of non-small cell lung cancer with epidermal growth factor receptor (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 1b study, which includes a cohort evaluating firmonertinib in patients with EGFR PACC mutations (FURTHER; NCT05364043).   In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations, in partnership with Beijing InnoCare Pharma Tech Co., Ltd.

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.

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, cash runway, estimates of our addressable market, activity of firmonertinib compared to available therapies, anticipated clinical milestones, including proof of concept data for firmonertinib in patients with NSCLC EGFR PACC mutations, top-line pivotal Phase 3 data for firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations, and the selection of an ADC development candidate, 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, 2023, filed with the Securities and Exchange Commission on March 28, 2024 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 is the FURTHER study for ArriVent's firmonertinib (AVBP) presenting at WCLC 2024?

The FURTHER study is a global, randomized Phase 1b trial evaluating firmonertinib at two dose levels as first-line monotherapy in TKI-naive, advanced NSCLC patients with EGFR PACC mutations. Interim data from this study will be presented at the 2024 World Conference on Lung Cancer.

When and where will ArriVent (AVBP) present the firmonertinib FURTHER study results?

ArriVent will present the interim results of the FURTHER study on Monday, September 9, 2024, from 8:58am to 9:05am PT during the Presidential Symposium 2 session at the 2024 World Conference on Lung Cancer in San Diego, California.

What makes ArriVent's firmonertinib (AVBP) FURTHER study significant for NSCLC treatment?

The FURTHER study is significant as it represents the first prospectively designed randomized clinical data for a small-molecule EGFR tyrosine kinase inhibitor in NSCLC patients with EGFR PACC mutations, potentially addressing an unmet medical need in this specific patient population.

Will ArriVent (AVBP) provide additional information about the firmonertinib FURTHER study?

Yes, ArriVent plans to host a virtual webinar on the firmonertinib program on September 9, 2024, at 4:30pm ET, in conjunction with the 2024 World Conference on Lung Cancer, providing an opportunity for more detailed discussion of the study results.