Appclon: "Threefold Increase in Progression-Free Survival for HER2-Positive Gastric Cancer"

Appclon announced on June 4 that AC101, which was licensed out to Henlius, demonstrated long-term effects of over two years following administration in a Phase 2 clinical trial targeting patients with HER2-positive advanced gastric cancer.

The results were presented at the American Society of Clinical Oncology (ASCO) meeting, which began on May 29. An Appclon representative stated, "The ASCO presentation will mark a new turning point in the treatment of HER2-positive gastric cancer with AC101," adding, "We plan to accelerate global clinical development and commercialization of AC101 to provide effective and affordable treatment options to patients worldwide."

According to the latest results from the Phase 2 trial, the group of patients who received AC101 in combination with other drugs maintained stable long-term therapeutic effects. This outcome surpasses previous research findings and once again demonstrates the superior efficacy of AC101. To date, there have been no cases worldwide in which a similar dual HER2 blockade therapy for HER2-positive gastric cancer has received marketing approval.

According to the ASCO presentation, follow-up for up to two years after administration showed that the AC101 combination group reduced 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, resulting in more than a threefold increase in survival at two years.

AC101 has simultaneously received orphan drug designation (ODD) for gastric cancer treatment from both the U.S. Food and Drug Administration (FDA) and European regulatory authorities. In addition, it has met the requirements for accelerated approval from the U.S. FDA, received conditional marketing authorization and priority medicine status from the European Medicines Agency (EMA), and has been designated as an innovative therapy by the National Medical Products Administration of China, receiving positive evaluations from major global regulatory agencies.