The Second Indication of Ivonescimab in
NSCLC
2L+ EGFRm NSCLC Already Approved in May 2024
HONG
KONG, Aug. 14, 2024 /PRNewswire/ -- Akeso, Inc.
(HKEX: 9926.HK) ("Akeso,") today announced that the National Center
for Drug Evaluation of the State Drug Administration of
the People's Republic of China
(NMPA CDE) has granted priority review of the supplemental New Drug
Application (sNDA) to 依达方® (ivonescimab), a first-in-class
PD-1/VEGF bi-specific antibody developed by Akeso, as
monotherapy for first-line treatment of PD-L1 positive (PD-L1
TPS≥1%) locally advanced or metastatic non-small cell lung cancer
(NSCLC).
This marks the second indication for which ivonescimab has been
granted priority review following the treatment of EGFR-mutant
non-squamous NSCLC that has progressed after EGFR-TKI therapy,
highlighting its significant clinical value.
This new indication application for ivonescimab is based on the
HARMONi-2 (AK112-303) study. At a prespecified interim
analysis conducted by an independent Data Monitoring Committee,
ivonescimab demonstrated a statistically significant and clinically
meaningful improvement in PFS by blinded independent radiology
review committee (BICR) compared to pembrolizumab, and the
hazard ratio (HR) was significantly better than expected. There are
no known Phase III clinical trials in NSCLC which have shown a
statistically significant improvement compared to pembrolizumab in
a head-to-head setting.
In May 2024, ivonescimab
combination therapy for EGFR-mutant non-squamous NSCLC that has
progressed after EGFR-TKI therapy was approved through priority
review, making it the world's first approved bispecific antibody
that combines "tumor immunotherapy" and "anti-angiogenesis"
mechanisms.
About Ivonescimab (AK112/SMT112)
Ivonescimab is a novel global first-in-class PD-1/VEGF
bi-specific immunotherapy drug independently developed by Akeso.
Ivonescimab is known as SMT112 in Summit Therapeutics' license
territories, including the United
States, Canada,
Europe, Japan, Central
America, South America, the
Middle East and Africa. Ivonescimab was granted marketing
approval by NMPA for the treatment of EGFR mutated locally advanced
or metastatic non-squamous NSCLC patients who have progressed after
EGFR TKI treatment. Currently, ivonescimab's first indication has
been approved in China, and Akeso
is conducting 5 Phase III trials including 2 global MRCTs and 4
registrational trials versus anti-PD-1 therapeutics. The Company is
also conducting multiple clinical trials of ivonescimab covering 16
indications including gastrointestinal cancer, hepatocellular
carcinoma and colorectal cancer.
About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company
committed to the research, development, manufacturing and
commercialization of the world's first or best-in-class innovative
biological medicines. Founded in 2012, the company has created a
unique integrated R&D innovation system with the comprehensive
end-to-end drug development platform (ACE Platform) and bi-specific
antibody drug development technology (Tetrabody) as the core, a
GMP-compliant manufacturing system and a commercialization system
with an advanced operation mode, and has gradually developed into a
globally competitive biopharmaceutical company focused on
innovative solutions.
With fully integrated multi-functional platform, Akeso is
internally working on a robust pipeline of over 50 innovative
assets in the fields of cancer, autoimmune disease, inflammation,
metabolic disease and other major diseases, with 19 drug candidates
in the clinical stage, including 8 multispecific antibodies. Akeso
has successfully promoted the commercialization of three innovative
biological drugs, and marketing applications of multiple
indications are submitted for 4 new drugs. 安尼可®, approved for
marketing in August 2021, is
currently the only differentiated PD-1 monoclonal antibody that
applies the IgG1 subtype with modified Fc-null domain. 开坦尼®
(PD-1/CTLA-4 bi-specific antibody, Cadonilimab injection) was
granted marketing approval in June
2022, making it the world's first bi-specific antibody drug
for tumor immunotherapy and the first bi-specific antibody new drug
in China.In May 2024, 依达方® (PD-1/VEGF
bi-specific antibody, Ivonescimab injection), the first-in-class
PD-1/VEGF bi-specific antibody independently developed by Akeso,
was granted marketing approval for the treatment of epidermal
growth factor receptor ("EGFR") mutated locally advanced or
metastatic non-squamous non-small cell lung cancer ("nsq-NSCLC"),
making it the world's first approved PD-1/VEGF bi-specific
antibody. The drug had been granted three Breakthrough Therapy
Designations for the treatment of lung cancer by the Center for
Drug Evaluation (CDE). In December
2022, a license agreement with total potential deal value of
USD $5 billion, plus a low
double-digit royalty of product net sales in the authorized
countries of the new drug, 依达方®, set a new record in overseas
licensing for the transaction amount of a single innovative drug in
China.
Through efficient and breakthrough R&D innovation, Akeso
always integrates superior global resources, develops the
first-in-class and best-in-class new drugs, provides affordable
therapeutic antibodies for patients worldwide, and continuously
creates more commercial and social values to become a global
leading biopharmaceutical enterprise.
Shihui Zhu
shihui.zhu@akesobio.com
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SOURCE Akeso, Inc.