SKB BIO-B(06990):The core product sac-TMT has been approved by the National Medical Products Administration for a second indication, for the treatment of EGFR-mutated non-small cell lung cancer.

SKB BIO-B(06990) announced that its antibody drug conjugate (ADC) Lukan satumab tesirine monoclonal antibody (sac-TMT, formerly known as SKB264/MK-2870) has been approved by the National Medical Products Administration (NMPA) for a second indication. It is now approved for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in adult patients with EGFR gene mutation who have progressed after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy. This is the first TROP2ADC drug approved for lung cancer indication worldwide. Compared to the current standard treatment, sac-TMT significantly prolongs the overall survival benefit for these patients. This approval is based on a multicenter, randomized, controlled pivotal clinical study (OptiTROP-Lung03) that evaluated the efficacy and safety of sac-TMT monotherapy with a 5mg/kg intravenous injection every two weeks (Q2W) versus docetaxel in patients with locally advanced or metastatic EGFR-mutant NSCLC who have failed EGFR-TKI and platinum-based chemotherapy (sequentially or in combination). The interim analysis results showed that compared to docetaxel, sac-TMT monotherapy demonstrated significant and clinically meaningful improvement in objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Previously, NMPA has approved sac-TMT for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer in patients who have received at least two prior systemic therapies (with at least one therapy targeting the advanced or metastatic stage); and has accepted a supplemental new drug application (sNDA) for sac-TMT monotherapy in patients with EGFR-mutant NSCLC who have failed EGFR-TKI treatment.