Kelun has won approval in China for its Merck & Co.-partnered sacituzumab tirumotecan (sac-TMT), a TROP2-targeting antibody-drug conjugate, as the world’s first in the class to be cleared for lung cancer.
The approval was based on positive PFS and OS results from the Phase II OptiTROP-Lung03 trial with sac-TMT as monotherapy versus docetaxel in Chinese EGFR-mutated NSCLC patients who had failed on an EGFR inhibitor and platinum-based chemotherapy.
The ADC was administered at 5mg/kg Q2W in OptiTROP-Lung03, compared with 4mg/kg Q2W in Merck's Phase III TroFuse-004 trial in a similar indication.

Kelun Wins World’s First TROP2 ADC Approval In Lung Cancer

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