Abclon "AC101 Improves Survival Rate in HER2-Positive Gastroesophageal Cancer... Rising Expectations as First-Line Treatment"

Appclon announced on the 23rd that AC101, which was licensed to Henlius, showed significantly superior data compared to the control group, raising expectations for success as a first-line treatment for HER2 (human epidermal growth factor receptor 2)-positive metastatic gastric cancer.

After licensing AC101 to Henlius, it is currently undergoing global Phase 3 clinical trials under the code name HLX22 in China, the United States, Japan, and Australia. The company disclosed the clinical research abstracts on treatment efficacy and safety to be presented at the ASCO GI 2025 symposium on gastrointestinal cancers, held in the United States from the 23rd to the 25th (local time).

HER2-positive metastatic gastric cancer occurs in approximately 12% to 23% of cancer patients. Although HER2-positive patients can receive combination therapy with trastuzumab and chemotherapy, prognosis is often poor, increasing the need for effective treatments.

The recently announced study evaluated the combination therapy of AC101 antibody, trastuzumab, and Xelox as a first-line treatment for HER2-positive metastatic gastric cancer patients.

According to the presented clinical study results, the group receiving the HLX22, trastuzumab, and Xelox (hereafter HLX22) combination therapy showed significantly higher survival rates compared to the placebo, trastuzumab, and Xelox (hereafter placebo) group. The HLX22 combination therapy group had not yet reached progression-free survival (PFS) (NR), while the placebo group reported 8.3 months. The 12-month survival rate was also markedly higher in the HLX22 group at 73.8%, compared to 34.2% in the placebo group. The HLX22 group recorded an objective response rate (ORR) of 87.1%, while the placebo group showed 80.6%.

Regarding the 24-month PFS rate, the HLX22 group significantly outperformed the placebo group with 61.5% versus 24.0%. The HLX22 group was still at a stage where overall survival (OS) could not be evaluated, whereas the placebo group reported 22.0 months. The company explained that treatment-related side effects were mostly manageable, and the incidence of severe adverse events was low.

An Appclon representative stated, “The results suggest that the HLX22 combination therapy can provide meaningful survival benefits to patients with HER2-positive metastatic gastric cancer,” adding, “In particular, treatment-related side effects are manageable, and HLX22 shows the potential to demonstrate better efficacy than existing treatment methods.”

He continued, “This study will bring a significant change to the treatment of HER2-positive metastatic gastric cancer,” emphasizing, “We expect it to offer hope to patients who need new treatment options.”