Kelun-Biotech Reports NMPA Approval of Sacituzumab Tirumotecan for HR+/HER2- Breast Cancer
Shots:
- The Chinese NMPA has approved sacituzumab tirumotecan for the treatment of adults with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy & ≥1L of CT in an advanced setting
- Approval was based on the P-III (OptiTROP-Breast02) trial assessing sac-TMT vs CT for the treatment of HR+/HER2- breast cancer, where 95.7% had visceral metastases, 75.9% had liver metastases; 52.9% were HER2-zero, while 47.1% were HER2-low
- Trial showed improved PFS (mPFS: 8.3 vs 4.1mos.), consistent across all subgroups, incl. HER2-zero & HER2-low, with favorable OS benefit & improved ORR (41.5% vs. 24.1%) observed
Ref: PRnewswire | Image: Kelun-Biotech | Press Release
Related News: Kelun-Biotech and Crescent Biopharma Enter Strategic Deal to Accelerate CR-001 and SKB105 Programs
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