Merck Launches International Multicenter Phase 2/3 Trial of SKB264 (MK-2870) in Endometrial Cancer

On November 15, 2023, Merck Sharp & Dohme AG registered a Phase 2/3 clinical trial for SKB264 (MK-2870) in the treatment of endometrial cancer on the Clinicaltrials.gov website.

This Phase 2/3 clinical trial plans to enroll 710 patients with advanced endometrial cancer who have undergone platinum-based chemotherapy and immunotherapy, with preliminary completion expected by 2028.

This Phase 2/3 clinical trial uses chemotherapy as the control group.

SKB264 (MK-2870) is an innovative TROP2-ADC independently developed by Kelun-Biotech. It utilizes a proprietary toxin-linker strategy (Kthiol design strategy) and incorporates a fully differentiated design. The toxin employs a novel TOPO1 inhibitor with moderate cytotoxicity. A carbonate linker is used, enabling specific toxin release in the acidic tumor microenvironment while exerting a bystander effect. This linker is conjugated via cysteine, achieving a high DAR value of 7.4, ensuring good stability in circulation and significantly enhancing safety. The excellent molecular design allows SKB264 to achieve a better balance between efficacy and safety.

Summary

Kelun-Biotech's TROP2-ADC (SKB264/MK-2870) is making rapid progress, with both monotherapy and combination therapy, as well as clinical studies in China and internationally, advancing simultaneously. MSD is actively promoting the international clinical development of SKB264. Last month, a global multi-center Phase III clinical trial for EGFR-mutated non-small cell lung cancer was initiated, and now a global multi-center Phase 2/3 clinical trial for endometrial cancer has also been launched.

Editor: Baiji

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