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Home Merck Launches 12th Global Phase III Trial of Kelun-Biotech’s TROP2 ADC Sacituzumab Tirumotecan in First-Line PD-L1 Low/Negative Metastatic Triple-Negative Breast Cancer

Merck Launches 12th Global Phase III Trial of Kelun-Biotech’s TROP2 ADC Sacituzumab Tirumotecan in First-Line PD-L1 Low/Negative Metastatic Triple-Negative Breast Cancer

Apr 18, 2025 17:23 CST Updated 17:23
MSD

Pharmaceutical R&D and Manufacturer

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April 18,The Chinese Drug Clinical Trial Registry and Information Disclosure Platform shows that MSD has registered aComparison of Sac-TMT（Lukansatuzumab, TROP2 ADC)Combination/Non-combination of Pembrolizumab with TPCFirst-line treatment for unresectable/metastaticTriple-Negative Breast Cancer(Phase III Study with PD-L1 CPS < 10)（CTR20251453）。
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InterceptImage source:Drug Clinical Trial Registration and Information Disclosure Platform

This is aPhase III, Randomized, Open-Label Study（TroFuse-011）, aiming at previously untreated locally recurrent unresectable or metastaticTriple-negative breast cancer with PD-L1 CPS < 10Comparison among subjectsSac-TMT Monotherapy, Sac-TMT in Combination with Pembrolizumab（MK-3475）Efficacy and Safety of Combination Therapy vs. Physician's Choice of TreatmentThe primary endpoints of the study are PFS and OS.。
Insight database shows that this is the MSD's initiation for the drug.Item 12Global Multicenter Clinical Trial. This trial involves 253 institutions, with 144 participants planned in China and 1000 participants internationally. There were also 11 previous clinical trials, involvingOvarian cancer, cervical cancer, gastric cancer, non-small cell lung canceretc.:
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InterceptImage source: Insight Database
Sac-TMT is a product developed by Kelun-Biotech.TROP2 ADC, composed of the humanized monoclonal antibody Sacituzumab, an enzymatically cleavable Linker, and the novel topoisomerase I inhibitor T030 conjugate, with a drug-to-antibody ratio.（DAR）An average of up to 7.4.
The drugFirst approved for marketing by the NMPA in November 2024, for use inSecond-line Treatment for Triple-Negative Breast CancerIn March 2025, the drug was approved in China.New Indications, used forTreatment of locally advanced or metastatic EGFR mutation-positive disease that has progressed after treatment with EGFR TKI and platinum-based chemotherapyNon-squamous NSCLCAdult patients.
In May 2022, Kelun-Biotech signed a cooperation agreement with MSD, granting the latter the rights to develop, use, manufacture, and commercialize outside of Greater China.Exclusive rights to Sac-TMT.
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Screenshot source:Insight Database

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Editor：ccai
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