China-based Kelun-Biotech has announced that its TROP2-targeting antibody-drug conjugate (ADC) sacituzumab tirumotecan met the primary endpoint of progression-free survival (PFS) in the Phase III OptiTROP-Breast03 trial. The study evaluated the drug versus investigator's choice of chemotherapy in patients with inoperable, recurrent, or metastatic triple-negative breast cancer (TNBC) who had not received prior systemic therapy for advanced disease. An independent data monitoring committee confirmed a statistically significant and clinically meaningful improvement in PFS at a pre-specified interim analysis. While overall survival (OS) data remain immature, an early positive trend was observed.

The safety profile of sacituzumab tirumotecan was consistent with prior studies, with no new signals identified. This marks the first Chinese TROP2 ADC to report positive Phase III results in the first-line TNBC setting. Kelun plans to engage with China’s Centre for Drug Evaluation (CDE) to discuss the regulatory pathway for this indication. The asset is also approved in China for later-line TNBC treatment based on earlier trial data.

PharmCube's NextBiopharm® database shows that Kelun transferred R&D and commercialisation rights to MSD in 2022, which then received R&D funding from Blackstone Life Sciences in exchange for future sales royalties. Click here to request a free trial for NextBiopharm®.