Kelun-Biotech Secures Breakthrough Therapy Status in China for sac-TMT Plus Pembrolizumab in First-Line PD-L1-Positive NSCLC
Tuesday, January 06, 2026
Kelun-Biotech has received Breakthrough Therapy Designation (BTD) in China for sacituzumab tirumotecan (sac-TMT) used in combination with pembrolizumab as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The designation applies to patients whose tumours are PD-L1 positive (tumour proportion score of at least 1%) and who do not have EGFR or ALK genetic alterations.
The designation was granted by the Centre for Drug Evaluation under China’s National Medical Products Administration. BTD is intended for treatments that show clear clinical benefit or address serious conditions where current options are limited. Medicines granted this status may qualify for faster development, priority review and, where appropriate, conditional approval.
The decision follows positive results from the Phase III OptiTROP-Lung05 study, which assessed sac-TMT combined with pembrolizumab as an initial treatment for PD-L1-positive NSCLC. The study met its primary endpoint, showing a significant improvement in progression-free survival, with a positive trend also seen in overall survival. This trial is the first Phase III study of an antibody–drug conjugate combined with immunotherapy to achieve its main goal in first-line NSCLC.
This latest decision marks the fifth Breakthrough Therapy Designation for sac-TMT in China. Previous designations covered several breast cancer and lung cancer settings, including triple-negative breast cancer, EGFR-mutant NSCLC after targeted therapy, and combinations with other immunotherapies.
Sac-TMT is a TROP2-targeted antibody–drug conjugate developed by Kelun-Biotech to treat a range of advanced solid tumours, including lung, breast, gastric and gynaecological cancers. The medicine uses a proprietary linker to attach a topoisomerase I inhibitor payload to a humanised antibody that targets TROP2 on tumour cells. Once inside the cancer cell, the payload causes DNA damage, leading to cell death. The design also allows the drug to affect nearby tumour cells, helping to increase its anti-cancer effect.
In 2022, Kelun-Biotech granted MSD exclusive rights to develop and commercialise sac-TMT outside Greater China. Within China, sac-TMT is already approved for three cancer indications, including certain forms of NSCLC and triple-negative breast cancer. Two of these uses have been added to China’s National Reimbursement Drug List, which is expected to improve patient access.
Sac-TMT is the first TROP2 antibody–drug conjugate approved for lung cancer worldwide. An additional application for its use in hormone receptor-positive, HER2-negative breast cancer has also entered China’s priority review process.
Kelun-Biotech is currently running nine registration-focused clinical studies in China. Globally, MSD is leading 15 Phase III trials of sac-TMT, either alone or in combination with pembrolizumab or other cancer treatments, across multiple tumour types.
Source: prnasia.com
