Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKEX: 6990), a China-based holding subsidiary of Kelun Pharmaceutical (002422.SZ), announced on Thursday that the journal of Annals of Oncology (Impact Factor: 65.4) has published the clinical study results of TROP2 ADC sacituzumab tirumotecan (sac-TMT) monotherapy for advanced or metastatic urothelial carcinoma (UC) patients.

This study is claimed to provide the first evidence of sac-TMT's potential significant clinical benefit for patients with advanced UC.

This publication is based on the efficacy and safety results of cohort 9 of a phase II MK-2870-001/KL264-01 study evaluating sac-TMT monotherapy in patients with advanced or metastatic UC and disease progression after chemotherapy and immune checkpoint inhibitors. The company says that Sac-TMT employs the only currently available irreversible conjugation technology, combined with the novel toxin - a topoisomerase I inhibitor KL610023 (T030). This is designed to enhance stability, ensuring greater release of the toxin T030 at tumour sites. The company says this guarantees precise and potent tumour cell killing, achieving an effective balance between efficacy and safety. With its unique structural design, sac-TMT is claimed to have demonstrated outstanding therapeutic potential in clinical studies.

Sichuan Kelun-Biotech says the results showed that sac-TMT 5 mg/kg monotherapy every 2 weeks demonstrated promising antitumor activity in participants with heavily pre-treated advanced or metastatic UC, with a manageable safety profile, warranting further evaluation of sac-TMT in this population.