SKB BIO-B(06990): The core product SAC-TMT will announce research results at the 2025 ASCO GU Cancer Symposium.

SKB BIO-B (06990) announced that the company will present the results of the phase 1/2 study (NCT04152499) of its antibody-drug conjugate (ADC) sacituzumab govitecan (sac-TMT, formerly known as SKB264/MK-2870) in the treatment of unresectable, locally advanced or metastatic urothelial carcinoma (UC) patients who have previously received anti-cancer therapy or have 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. The results will be presented in the poster session on February 14, 2025 (abstract #796). The abstract of the study will also be published on the official website of the 2025 ASCO GU Cancers Symposium on February 10, 2025. Eligible participants were histologically/cytologically confirmed to have locally advanced or metastatic UC, had disease progression after at least one prior platinum-based therapy, and had previously received anti-PD-(L)1 therapy. For platinum-refractory patients, those who had previously received anti-PD-(L)1 therapy (with new neoadjuvant/adjuvant therapy considered as a treatment regimen if progression occurred within 12 months) were also eligible. Patients had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 1 and measurable lesions confirmed by CT/MRI. Patients received sacituzumab govitecan (sac-TMT) at a dose of 5 mg/kg every two weeks (Q2W) until disease progression, intolerable toxicity or withdrawal of consent. As of the data cut-off date (June 30, 2024), the minimum follow-up time for 49 treated patients was 9 weeks. 11 patients received sacituzumab govitecan (sac-TMT) as second-line treatment; 38 patients received sacituzumab govitecan (sac-TMT) as third-line or higher treatment. The median ages were 62 years and 61 years, with the majority of patients being Asian (82%; 100%). The median (range) follow-up times were 9.5 (7.5-16.2) months and 11.7 (7.8-17.4) months. The objective response rate (ORR) for all patients was 31%. As of the safety data cut-off 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%), decreased neutrophil count (29%), decreased white blood cell count (16%), stomatitis (12%), and decreased platelet count (8%), which were generally reversible with dose adjustments and/or supportive care. There were no grade 5 treatment-related adverse events; one patient discontinued sacituzumab govitecan (sac-TMT) due to treatment-related adverse events.