Appclon "Antibody Therapy AC101 Shows High Potential as First-Line Treatment for Metastatic Stomach Cancer"

Appclon announced that Henlius Biotech Shanghai (hereinafter Henlius), to which it licensed the technology (L/O), presented the interim results of the Phase 2 clinical trial of AC101, currently underway as a first-line treatment for HER2-positive gastric cancer patients, at the ASCO GI (San Francisco), the gastrointestinal cancer symposium of the American Society of Clinical Oncology (ASCO), on the 18th (local time). The trial involved a total of 53 patients.

Gastric cancer is a highly threatening disease with approximately one million new cases annually, ranking fifth in global cancer incidence. Particularly, the 5-year survival rate for advanced gastric cancer patients is only 6%. Among these, the HER2-positive rate is observed in about 20% of gastric or gastroesophageal junction adenocarcinomas, and the treatment prognosis is known to be poor. Despite this, no existing treatments, including ADCs (antibody-drug conjugates), have shown sufficient efficacy, making the development of new therapies urgently needed.

According to the interim results of the Phase 2 clinical trial of AC101 (HLX22) presented that day, it was explained that in HER2-positive locally advanced/metastatic patients, the combination of AC101 with the currently used standard treatment HLX02 (Herceptin biosimilar) + XELOX regimen showed superior therapeutic efficacy compared to the standard treatment alone.

This clinical trial was conducted with three groups: AC101 low-dose combination group (15 mg/kg), AC101 high-dose combination group (25 mg/kg), and a control group. The objective response rate (ORR) measured at 48 weeks post-administration was 58.8% in the low-dose group, 38.9% in the high-dose group, and 16.7% in the control group. The company noted that the low-dose group demonstrated more than three times better treatment efficacy than the control group.

The median progression-free survival (PFS) was 8.2 months in the control group, 15.1 months in the high-dose group, and had not yet reached the median in the low-dose group, confirming its superiority.

Overall survival (OS) median values were not reached in any group as the trial is ongoing; however, the hazard ratio for OS was lower in both the high-dose and low-dose groups compared to the control group. Additionally, the duration of response (DOR), the period during which the tumor response is maintained before regrowth, was 6.8 months in the control group, 12.4 months in the high-dose group, and not reached in the low-dose group, demonstrating the excellent efficacy of AC101 combination therapy.

A company representative stated, "AC101, developed by our company as an antibody therapy targeting HER2 for gastric cancer, shows even greater efficacy when combined with the Herceptin antibody, firmly establishing its potential as a first-line standard treatment for HER2-positive gastric cancer." They added, "In particular, Henlius expects to maximize therapeutic effects through the combination therapy of its developed Herceptin biosimilar and AC101, as well as secure high competitiveness in the market."

Meanwhile, Appclon will receive milestones according to the progress of AC101’s clinical trials in China and globally, as well as royalties on sales upon commercialization.

This content was produced with the assistance of AI translation services.