Sichuan Kelun Pharmaceutical: Research results of Lukan Sandaizhuzdan Antibody (SAC-TMT) will be announced at the ASCO GU Cancer Symposium in 2025.

Sichuan Kelun Pharmaceutical (002422.SZ) announced that its subsidiary Sichuan Kelun Bote Bio-Pharmaceutical Co., Ltd. ("Kelun Bote") will present the efficacy and safety results of its antibody-drug conjugate (ADC) Luconashatuzumab monatox (Sac-TMT, formerly known as SKB264/MK-2870) (Jiatai Lai) in the Phase 1/2 study KL264-01/MK2870-001 (NCT04152499) for the treatment of unresectable, locally advanced or metastatic urothelial carcinoma (UC) patients who have previously received anticancer therapy or experienced disease progression after treatment at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in San Francisco, USA, from February 13 to February 15, 2025. These study results will be presented in a poster session on February 14, 2025 (Abstract #796). The abstract of the study will also be released on the official website of the 2025 ASCO Genitourinary Cancers Symposium on February 10, 2025. The study enrolled participants who were histologically/cytologically confirmed to have locally advanced or metastatic UC, had disease progression after at least one prior platinum therapy, and had received prior anti-PD-(L)1 treatment. Participants who were platinum intolerant and had received prior anti-PD-(L)1 treatment (with neoadjuvant/adjuvant therapy considered as one treatment regimen if patients progressed within 12 months) were also eligible. Participants had an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 1 and had measurable lesions confirmed by CT/MRI. Participants were treated with Sac-TMT at a dose of 5mg/kg every two weeks (Q2W) until disease progression, intolerable toxicity, or withdrawal of consent. As of the data cutoff date (June 30, 2024), the minimum follow-up time for 49 treated patients was 9 weeks. 11 patients received Sac-TMT as second-line therapy, while 38 patients received Sac-TMT as third-line or later therapy. The median ages of the patients were 62 and 61 years; the majority were Asian (82%; 100%). The median (range) follow-up periods were 9.5 (7.5-16.2) months and 11.7 (7.8-17.4) months, respectively. The objective response rate (ORR) was 31% in all patients. As of the safety data cutoff date (May 21, 2024), 59% of patients experienced grade 3 treatment-related adverse events. The most common grade 3-4 treatment-related adverse events were anemia (39%), neutropenia (29%), leukopenia (16%), stomatitis (12%), and thrombocytopenia (8%), which were generally reversible with dose adjustments and/or supportive care. There were no grade 5 treatment-related adverse events; one patient discontinued Sac-TMT due to treatment-related adverse events.