Form 8-K
8-K — ArriVent BioPharma, Inc.
Accession: 0001104659-26-113898
Filed: 2026-10-06
Period: 2026-10-06
CIK: 0001868279
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Regulation FD Disclosure
Item: Other Events
Item: Financial Statements and Exhibits
Documents
8-K — tm2627092d1_8k.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (tm2627092d1_ex99-1.htm)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 6, 2026
ARRIVENT
BIOPHARMA, INC.
(Exact name of registrant as specified in its
charter)
Delaware
001-41929
86-3336099
(State
or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS
Employer
Identification No.)
18 Campus Boulevard, Suite 100
Newtown Square, PA
19073
(Address
of principal executive offices)
(zip
code)
Registrant’s telephone number, including
area code: (628) 277-4836
N/A
(Former name or former
address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock,
$0.0001 par value per share
AVBP
The
Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange
Act of 1934 (17 CFR §240.12b-2).
Emerging Growth Company x
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01
Regulation FD Disclosure.
On October 6, 2026, ArriVent BioPharma, Inc. issued a press release
announcing an update from the Phase 3 FURVENT trial of firmonertinib in first-line EGFR exon 20 insertion mutant non-small cell lung cancer.
A copy of the press release is filed as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 7.01.
The information
in this Item 7.01 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed
incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange
Act, except as shall be expressly set forth by specific reference in such filing.
Item 8.01
Other Events.
The information set forth in the press release referred to in Item
7.01 above, other than the second paragraph thereof, is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No.
Description
99.1
Press Release dated October 6, 2026.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ARRIVENT BIOPHARMA, INC.
By:
/s/ Winston Kung
Winston Kung
Chief Financial Officer and Treasurer
Date: October
6, 2026
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: tm2627092d1_ex99-1.htm · Sequence: 2
Exhibit 99.1
ArriVent Announces Program Update from the Phase
3 FURVENT Trial of Firmonertinib in First-Line EGFR Exon 20 Insertion Mutant NSCLC
NEWTOWN SQUARE, PA, October 6, 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
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