AbClon, AC101 Improves HER2-Positive Gastric Cancer Progress…
AbClon announced on the 4th that AC101
(Henlius code name HLX22), which was licensed to Henlius, showed long-term
efficacy exceeding two years after administration in a Phase 2 clinical trial
for patients with HER2-positive advanced gastric cancer. These results were
presented at the American Society of Clinical Oncology (ASCO) annual meeting,
which took place in Chicago, USA, from May 29th to early this month.
According to the latest results from the
HLX22-GC-201 Phase 2 clinical trial, long-term treatment effects were stably
maintained in the patient group that received AC101 in combination with other
drugs. This achievement surpasses previously reported results, once again
proving AC101's excellent therapeutic efficacy. The HLX22-GC-301 Phase 3
clinical trial is also underway in the United States, Europe, Japan, South
Korea, China, South America, and Australia. To date, no similar dual HER2
blockade therapy for HER2-positive gastric cancer treatment has received
marketing authorization worldwide.
Gastric cancer is a fatal disease with
nearly 1 million new patients annually worldwide and over 660,000 deaths.
Particularly, the 5-year survival rate for advanced gastric cancer is only 6%,
highlighting a critical need for innovative treatments that surpass existing
therapies.
According to the ASCO presentation,
follow-up over two years showed that the AC101 combination group demonstrated
an excellent effect, reducing the risk of disease progression by 80% compared
to the control group. The median progression-free survival (PFS) in the AC101
combination group has not yet been reached, while it was 8.3 months in the
control group. The 12-month and 24-month progression-free survival (PFS) rates
were 77.1% and 54.8%, respectively, compared to 40.8% and 17.5% in the control
group, indicating a more than threefold increase in survival rate after two
years. The objective response rate (ORR) was 87.1% for the AC101 combination
group and 80.6% for the control group. The duration of response (DOR) has not
reached the median in the combination group, while it was 9.7 months in the
control group. Overall survival (OS) has also not reached the median in the
combination group, while it was 16.4 months in the control group, demonstrating
AC101's excellent survival-prolonging effect.
Due to these innovative therapeutic
effects, AC101 has simultaneously received Orphan Drug Designation (ODD) for
gastric cancer treatment from the U.S. Food and Drug Administration (FDA) and
European regulatory authorities. Furthermore, it has met the criteria for
accelerated approval from the U.S. FDA, and received positive evaluations from
major global regulatory bodies, including conditional marketing authorization
and priority medicine designation from the European Medicines Agency (EMA), and
innovative drug designation from China's National Medical Products
Administration (NMPA).
At ASCO, the design and synopsis of the
HLX22-GC-301 Phase 3 clinical trial were also introduced. The trial is being
conducted into 550 HER2-positive gastric cancer patients worldwide, with
participation from leading medical institutions such as MD Anderson Cancer
Center, Japan's National Cancer Center, and Peking University Cancer Hospital.
The study is designed to compare the efficacy and safety between AC101 +
trastuzumab + XELOX combination therapy and trastuzumab + XELOX ± pembrolizumab
combination therapy. Additionally, precise analysis based on HER2 expression
levels, region (Asia, Europe, North America), and PD-L1 expression levels (CPS)
will be performed, aiming to establish a new standard treatment for
HER2-positive gastric cancer.
A Phase 3 clinical trial for AC101 is also
underway in South Korea. It received clinical approval from the Ministry of
Food and Drug Safety on April 16th and involves 10 domestic hospitals as part
of the global multi-national clinical trial. Some patients will directly
receive AC101 in South Korea.
Clinical trials for expanding AC101's
indications to other cancer types are also actively progressing. A Phase 2
clinical trial combining AC101 with trastuzumab Deruxtecan (T-DXd) for HER2-low
expression and hormone receptor (HR)-positive locally advanced or metastatic
breast cancer patients is underway in China, with the first patient having
completed treatment.
An AbClon official stated, "The ASCO
presentation will be a new turning point for AC101 in the treatment of
HER2-positive gastric cancer. We plan to accelerate AC101's global clinical
development and commercialization to provide effective and affordable treatment
options to patients worldwide."
They added, "Henlius expects AC101's peak
annual sales target to be $10 billion, and AbClon anticipates securing over 700
billion won in annual royalties. Given the recent pace of progress, we believe
we are approaching the commercialization stage through conditional marketing
authorization by country."
