By Fineline Cube 
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that another indication approval filing for its sacituzumab tirumotecan (SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC), has been accepted for review by the National Medical Products Administration (NMPA). The filing seeks approval for the drug’s use in adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) unresectable locally advanced or metastatic breast cancer (BC) who have received endocrine therapy in the past and other systematic treatment in the advanced or metastatic stage.
Clinical Trial Results
Kelun-Biotech leveraged the positive results from the regulatory Phase III OptiTROP-Breast02 study for the filing, the fourth indication filing for sacituzumab tirumotecan. In the randomized, open-label, multi-center Phase III OptiTROP-Breast02 study, sacituzumab tirumotecan (sac-TMT) alone showed significant statistical and clinical improvements in progression-free survival (PFS) compared with the investigator’s choice of chemotherapy. The primary endpoint, evaluated by the Blinded Independent Review Committee (BIRC), demonstrated a significant reduction in the risk of disease progression or death.
Previous Approvals and Licensing Deal
Sacituzumab tirumotecan was the target of a licensing deal between Merck, Sharp & Dohme (MSD) for territories outside Greater China in May 2022. The drug is the first home-grown ADC with full approval in China for use in adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies. It is also approved for adult patients with EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy. Additionally, the drug is awaiting regulatory decisions in China as a monotherapy for patients with EGFR-mutant NSCLC who have failed after EGFR-TKI therapy.-Fineline Info & Tech