Chinese pharmaceutical company Sichuan Kelun-Biotech Biopharmaceutical Co Ltd reported on Saturday that trial results for the novel TROP2 antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) have been published in Nature Medicine, an international medical journal.
A Phase III registrational clinical study evaluating sac-TMT for the treatment of adult patients with locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC) 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). Data from this study were presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Based on an early Phase I/II clinical study, the article also reports on the efficacy and safety of sac-TMT in the treatment of adult patients with previously treated advanced non-small-cell lung cancer (NSCLC) with or without epidermal growth factor receptor (EGFR) mutations. Additionally, the article explores in vitro experiments on the potential mechanisms of sac-TMT treatment for NSCLC, suggesting that EGFR mutations can increase the endocytosis and anti-tumour activity of TROP2 ADCs.
Dr. Michael Ge, Kelun-Biotech CEO, 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."
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