Today, Kelun Biotech announced that its TROP2-targeted ADC drug SKB264 (Lukang Satuzumab) has been approved for marketing for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least 2 systemic treatments (at least 1 of which is for advanced or metastatic stages).

Lukang Satuzumab is the first domestically produced and the second global TROP2 ADC drug approved for marketing. This approval is based on the positive results of the Phase III OptiTROP-Breast01 study, which evaluates the efficacy and safety of Lukang Satuzumab compared with chemotherapy as a third-line treatment for patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC).

The latest results published at ASCO 2024 showed that as of November 30, 2023, compared with chemotherapy, ruconazole reduced the risk of disease progression or death by 69% (HR=0.31, 95% CI: 0.22-0.45, P<0.00001). According to the results of BICR evaluation, the mPFS of the ruconazole group and the chemotherapy group were 6.7 months and 2.5 months, respectively, and the PFS rates at 9 months were 34.0% and 5.9%, respectively, reaching the primary endpoint.

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