#China #Chengdu #Kelun-Biotech #Sacituzumab #Lung Cancer

Kelun-Biotech’s Sacituzumab Tirumotecan Approved for NSCLC

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has just announced an exciting development in the field of oncology: the National Medical Products Administration (NMPA) of China has granted marketing approval for its antibody-drug conjugate, Sacituzumab Tirumotecan (sac-TMT), for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is EGFR-mutant positive. This approval marks the second indication for sac-TMT.

A Milestone in Lung Cancer Treatment

The recent approval is particularly significant as it represents the first TROP2-directed ADC drug authorized for lung cancer treatment worldwide. This new treatment option comes at a crucial time, offering renewed hope for patients who have exhausted previous therapies, including EGFR-tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy. With lung cancer being among the leading causes of cancer-related deaths globally, the introduction of sac-TMT into the treatment landscape could substantially benefit patient survival rates.

The basis for this approval stems from a pivotal study named OptiTROP-Lung03, which was a multi-center, randomized, controlled trial aimed at assessing sac-TMT's effectiveness compared to docetaxel. Notably, the study indicated that patients receiving sac-TMT showed statistically and clinically significant improvements in important health metrics. These improvements included overall survival (OS), progression-free survival (PFS), and objective response rate (ORR), all suggesting a considerable enhancement in patient outcomes.

Addressing Unmet Medical Needs

Dr. Michael Ge, CEO of Kelun-Biotech, expressed enthusiasm about this latest milestone, emphasizing the company’s commitment to addressing unmet medical needs in the oncology segment, particularly for patients battling advanced stages of EGFR-mutant NSCLC. “The successful approval of this new indication will help to address an unmet treatment need for patients with later-stage EGFRm NSCLC in China,” he highlighted. Kelun-Biotech, in collaboration with Merck Sharp & Dohme (MSD), is already conducting ten registrational Phase III clinical studies, emphasizing their proactive approach to advancing cancer treatment globally.

Insights on NSCLC

Non-small cell lung cancer (NSCLC) accounts for approximately 80-85% of all lung cancer cases, with EGFR mutations being especially prevalent in patients in China. According to the latest guidelines from the Chinese Society of Clinical Oncology (CSCO), treating stage IV EGFR-mutant NSCLC typically involves the administration of EGFR-TKIs as a first-line therapy. However, the treatment landscape remains challenging, as existing medications often become ineffective in patients who have previously failed EGFR-TKI and platinum-based therapy. This highlights the urgent necessity for novel treatment options like sac-TMT to enhance survival rates among these patients.

About Sac-TMT

Sac-TMT is a carefully developed human TROP2 ADC that acts on advanced solid tumors. Its innovative composition involves a proprietary payload: a belotecan-derived topoisomerase I inhibitor. This mechanism specifically targets TROP2 antigens on cancer cells, facilitating the release of cytotoxic agents that induce cell death. Furthermore, sac-TMT has already been approved for treating unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), giving it a diverse application in oncology.

As the company continues to expand its research and clinical trials, the hope remains that more effective and targeted cancer treatment options will become available, addressing the tremendous burden of disease and improving the lives of patients.

Through innovative approaches and rigorous research, Kelun-Biotech is poised to play a pivotal role in the future of cancer therapies.

For more information about Kelun Biotech and their product offerings, visit their official website at Kelun Biotech.