Sacituzumab Tirumotecan Earns Approval in China for Pretreated Advanced TNBC

CAR-T Digest - August 2020

27 Nov 2024: Sacituzumab Tirumotecan Earns Approval in China for Pretreated Advanced TNBC

Sacituzumab tirumotecan has been approved by China’s National Medical Products Administration (NMPA) to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have previously received at least two systemic therapies, including one in the metastatic setting
It is the first TROP2-directed ADC approved in China, marking a milestone as the first fully approved ADC developed domestically by Kelun-Biotech
The Phase 3 OptiTROP-Breast01 trial demonstrated significant clinical efficacy, with patients treated with sacituzumab tirumotecan achieving a mPFS of 5.7 months compared to just 2.3 months for those receiving chemotherapy
The interim overall survival (OS) analysis revealed a statistically significant improvement in the Sacituzumab tirumotecan arm, with a hazard ratio (HR) of 0.53; 95% CI, 0.36 to 0.78; P =0.0005, the median OS was not reached (95% CI, 11.2 to NE) with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. Additionally, the Sacituzumab tirumotecan arm demonstrated a higher overall response rate (45.4% vs. 12.0%)
The safety analysis indicated that 100% of patients in the sacituzumab tirumotecan arm experienced treatment-related adverse effects (TRAE), though the rate of severe TRAEs (grade 3 or higher) was comparable between both treatment arms (57.7% for sacituzumab tirumotecan vs. 56.8% for chemotherapy)