The Annals of Oncology journal has released clinical research findings from Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. on TROP2 ADC sacituzumab tirumotecan monotherapy for patients with advanced or metastatic urothelial carcinoma (UC) (Impact Factor: 65.4). For patients with advanced UC, this trial offers the first proof of sac-TMT’s possible substantial therapeutic effect.
Cohort 9’s effectiveness and safety findings from a phase II MK-2870-001/KL264-01 study assessing sac-TMT monotherapy in patients with advanced or metastatic UC and disease progression following chemotherapy and immune checkpoint inhibitors served as the basis for this article. Sac-TMT uses the novel toxin, a topoisomerase I inhibitor KL610023 (T030), in conjunction with the only irreversible conjugation method currently available. By improving stability, more T030 toxin is released at tumor locations. It ensures accurate and powerful destruction of tumor cells, striking a good balance between safety and effectiveness. Sac-TMT has shown exceptional therapeutic promise in clinical trials thanks to its distinctive structural architecture.
According to the data, participants with advanced or metastatic UC who had received extensive pretreatment showed encouraging anticancer activity with a tolerable safety profile while receiving sac-TMT 5 mg/kg monotherapy every two weeks. This suggests that sac-TMT should be further evaluated in this cohort.
Of the 49 patients treated with sac-TMT as of the data cutoff date (February 17, 2025), 37 (76%) had received at least two previous lines of treatment. 18.8 months was the median follow-up period. The disease control rate was 71%, and the proven ORR was 31% (sac-TMT as second-line therapy showed a confirmed ORR of 50%). The 12-month probability of sustained response was 53%, and the median DOR was not attained. The 12-month PFS rate was 29%, and the median PFS was 5.5 months. There were no febrile neutropenia occurrences or grade 5 treatment-related adverse events (AEs) with sac-TMT, and the most common grade 3 or 4 treatment-related AEs (≥5%) were stomatitis and hematologic toxicities.
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