Early Positive Results for Merck and Kelun's TROP2-Targeted ADC in Treating Gastric Cancer at AACR

A recent study presented at the 2024 American Association for Cancer Research (AACR) annual meeting highlighted the potential of SKB264, an antibody-drug conjugate (ADC) developed by Merck and Kelun-Biotech, in treating gastric and gastroesophageal junction cancers. The drug targets the TROP2 protein, which is linked to poor outcomes in gastric cancer. In a Phase I/II trial involving 41 patients, SKB264 showed an 80.5% disease control rate and a 22% objective response rate, with a median response duration of 7.5 months. Notably, among patients who had undergone at least two prior treatments, the drug improved median progression-free survival to 3.7 months and overall survival to 7.6 months, with a 12-month survival rate of 32.6%. 

The ADC's payload is a belotecan-derived topoisomerase I inhibitor that induces DNA damage and cell death. A unique feature of SKB264 is its pH-sensitive linker that is cleaved by changes in the tumor's acidic environment and by enzymes within cancer cells, enhancing the targeted delivery of the drug. The study's lead author, Jordi Rodon, emphasized the significance of varying payloads and linkers in ADCs, noting that SKB264 did not exhibit the interstitial lung diseases observed with other ADCs targeting the same protein. 

Merck has secured worldwide rights to SKB264, except in the Greater China region, and is planning a global Phase III trial to compare its efficacy with the current standard treatment for patients with advanced gastric cancer who have received at least three prior treatments. The drug is also being studied in a Phase III trial for triple-negative breast cancer and a Phase II trial for non-small cell lung cancer and other advanced tumors. The collaboration between Merck and Kelun, a subsidiary of Sichuan Kelun Pharmaceutical, has been instrumental in advancing oncology research and development.

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