On April 12, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that results from a Phase 3 registrational clinical study evaluating the novel TROP2 antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) for the treatment of adult patients with advanced triple-negative breast cancer (TNBC) and results from an early Phase I/II clinical study of sac-TMT for the treatment of adult patients with advanced non-small-cell lung cancer (NSCLC) were published in the top international medical journal Nature Medicine (Impact Factor (IF)= 58.7) (Press release, Kelun, APR 12, 2025, View Source [SID1234651895]).
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Results
TNBC: Based on the results of the multicenter, randomized, controlled Phase III OptiTROP-Breast01 (NCT05347134) clinical study, the current publication reports on the efficacy and safety of sac-TMT versus investigator’s choice chemotherapy for the treatment of patients with locally advanced, recurrent or metastatic TNBC. The results of the study showed that sac-TMT demonstrated statistically and clinically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared to investigator’s choice chemotherapy. Based on this study, sac-TMT was approved for marketing for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). The data from this study were presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
NSCLC: Based on the results of two early clinical studies of sac-TMT, the article reports on the efficacy and safety of sac-TMT in previously treated advanced NSCLC with or without epidermal growth factor receptor (EGFR) mutations. The article also explored in vitro experiments on the potential mechanisms of sac-TMT treatment for NSCLC, suggesting that EGFR mutations can increase the endocytosis and anti-tumor activity of TROP2 ADCs.
Dr. Michael Ge, CEO of Kelun-Biotech said, "These successful publications in Nature Medicine mark the international academic community’s recognition of the clinical efficacy and application value of sac-TMT in the treatment of advanced TNBC and NSCLC. The Company’s novel product, sac-TMT, has been marketed in China for two indications. Meanwhile, the Company is also actively promoting the registrational clinical studies of sac-TMT in multiple indications, including breast cancer and lung cancer. Kelun-Biotech has always been committed to promoting innovation and leadership, and we look forward to continuing our research in the field of ADCs in partnership with MSD."
About sac-TMT (佳泰莱)
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).
To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the NMPA, and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD.