Full Press Release Details
Arrivent Announces Positive Interim Firmonertinib
Monotherapy Data From Global Phase 1b Study in EGFR PACC Mutant Non-Small Cell Lung Cancer and Plans to Advance into a Global Pivotal
16.0 months median progression free survival
(mPFS) with firmonertinib 240 mg by blinded independent central review (BICR) in first-line patients
Robust central nervous system (CNS) activity;
41% (7/17) confirmed complete response (CR) and 53% confirmed overall response (ORR) in CNS evaluable disease patients by BICR in overall
Enrollment of first patient in a randomized,
global pivotal Phase 3 (ALPACCA) study in first-line PACC patients expected in the second half of 2025
ArriVent to host virtual webinar today at 8
NEWTOWN SQUARE, PA, June 23, 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 encouraging additional follow up proof-of-concept data
from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with non-small cell lung cancer
(NSCLC) harboring EGFR PACC mutations and a clinical development update for the firmonertinib program for the treatment of EGFR PACC
mutant NSCLC. ArriVent plans to host a virtual webinar today June 23, 2025 at 8 am ET. To register for the event, please click here.
"We are encouraged by the strong progression-free
survival and durable systemic responses with long term firmonertinib treatment in frontline patients with EGFR PACC mutant NSCLC. Moreover,
the generally well-tolerated safety profile is consistent with what has been clinically established," said Bing Yao, Ph.D., Chairman
and Chief Executive Officer of ArriVent. "We believe these Phase 1b findings support the advancement of firmonertinib towards a
registration study for EGFR PACC mutant NSCLC, with potential for accelerated approval. We expect to enroll the first patient in the second
half of 2025 in our randomized, global pivotal ALPACCA Phase 3 trial."
Stuart Lutzker, M.D., Ph.D., Co-Founder and President
of R&D of ArriVent added, "Patients with PACC mutant NSCLC represent an underserved population. We believe the interim median
progression free survival of 16 months observed in the FURTHER study is clinically meaningful, and together with the compelling CNS activity
and favorable safety profile underscore the potential of firmonertinib to address unmet needs across patients with PACC mutations as a
once daily oral, chemo-free monotherapy"
Key Highlights of Interim Data:
Development Update - Firmonertinib for
the Treatment of EGFR PACC Mutations
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.
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; NCT05364073). 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
Forward-Looking Statements
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, activity of firmonertinib compared to available therapies, anticipated clinical milestones, including the
top-line pivotal global Phase 3 data for firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion
mutations, expansion of firmonertinib into a pivotal trial for 1L EGFR PACC mutant NSCLC and the timing of the first patient enrolled
in such study, participation in the global Phase 3 registrational study of firmonertinib in adjuvant uncommon mutant NSCLC, anticipated
IND filings for ADC candidates, 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.
LifeSci Advisors, LLC