China’s Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) will present efficacy and safety data from the Phase I/II KL264-01/MK-2870-001 study of its TROP2-targeted antibody-drug conjugate (ADC) sacituzumab tirumotecan (SKB264/MK-2870) at the ASCO-GU 2025 conference. The drug is being evaluated in patients with unresectable, locally advanced, or metastatic urothelial carcinoma (UC) who progressed after prior anti-cancer therapy.
Study Highlights
- Patient Enrollment: 49 patients with locally advanced or metastatic UC, all previously treated with platinum-based therapy and anti-PD-(L)1 agents.
- Efficacy: As of June 30, 2024, the objective response rate (ORR) was 31%, with one patient achieving complete response (CR) in the second-line setting.
- Safety: 59% of patients experienced ≥ grade 3 treatment-related adverse events (TRAEs), with no grade 5 TRAEs reported. One patient discontinued treatment due to TRAEs.
Drug Profile
Sacituzumab tirumotecan (SKB264/MK-2870) is a TROP2-targeted ADC licensed to Merck, Sharp & Dohme (MSD) for territories outside Greater China in May 2022. The drug received approval in China in November 2023 for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic therapies.
Strategic Outlook
The ASCO-GU 2025 presentation will highlight SKB264/MK-2870’s potential in UC, building on its approval in TNBC. Kelun-Biotech aims to expand the drug’s indications and global reach through partnerships with MSD.-Fineline Info & Tech
