China’s Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has unveiled the latest results from a Phase I/II study of its Category 1 biologic product candidate ASKB589, which is being evaluated as a first-line treatment for advanced gastric/esophagogastric junction (G/GEJ) adenocarcinoma. The study assessed the efficacy and safety of ASKB589 in combination with capecitabine and oxaliplatin (CAPOX) plus a PD-1 inhibitor. The findings were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI).
Study Results and Efficacy
The study enrolled 62 first-line CLDN18.2-positive G/GEJ adenocarcinoma patients. In the dose-escalation phase, 53 subjects received ASKB589 at 6 mg/kg in combination with CAPOX and a PD-1 inhibitor, including 47 stage IV G/GEJ adenocarcinoma patients with high CLDN18.2 expression and unrestricted PD-L1 expression status. The confirmed objective response rate (cORR) among stage IV patients with high CLDN18.2 expression was 76.1%, with a median duration of response (mDOR) of 13.9 months and a disease control rate (DCR) of 100%. As of December 20, 2024, with a median follow-up of approximately 15 months, the median progression-free survival (mPFS) was 12.45 months, and the overall survival (OS) rate at 18 months was 65.2%. In a subgroup analysis, the cORR was 81.8%, mPFS was 15.28 months, and the 18-month OS rate was 73.4%. The treatment regimen also demonstrated a favorable tolerability profile.
ASKB589: Mechanism and Competitive Landscape
ASKB589 is an innovative anti-tumor biologic independently developed by Beijing Aosaikang, leveraging antibody-dependent cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to target and kill tumor cells. This mechanism positions ASKB589 as a potential breakthrough in the treatment of CLDN18.2-positive cancers. Similar products, such as zolbetuximab-clzb (Vyllo) from Astellas Pharma, have already gained regulatory approval in China, highlighting the growing interest in CLDN18.2-targeted therapies.
Implications for Gastric Cancer Treatment
The promising results from the Phase I/II study underscore the potential of ASKB589 to improve outcomes for patients with advanced G/GEJ adenocarcinoma. With high response rates and durable efficacy, ASKB589 could offer a valuable addition to the current treatment landscape, particularly for patients with high CLDN18.2 expression. Beijing Aosaikang’s ongoing development efforts aim to further validate these findings and bring this novel therapy to market.-Fineline Info & Tech
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