SKB BIO-B (06990) announced that its antibody-drug conjugate (ADC) targeting human trophoblast cell surface antigen 2 (TROP2), sacituzumab govitecan (sac-TMT, also known as SKB264/MK-2870, brand name Jiatailai), has received approval from the National Medical Products Administration (NMPA) for a third indication. The drug is now approved for treating adult patients with EGFR gene mutation-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed following epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment.

Sacituzumab govitecan (sac-TMT) represents the first and only ADC globally that has demonstrated significant overall survival (OS) benefit compared to platinum-based doublet chemotherapy and has been approved for advanced NSCLC patients who have progressed after receiving only TKI treatment (2L). In the prespecified OS interim analysis, sacituzumab govitecan (sac-TMT) monotherapy showed statistically significant and clinically meaningful improvements in both progression-free survival and overall survival compared to the current standard platinum-based doublet chemotherapy, significantly extending both progression-free survival and overall survival for this patient population.

This approval is based on a randomized, open-label, multicenter Phase III clinical study (OptiTROP-Lung04), which has been selected as a Late-Breaking Abstract (LBA) for the 2025 European Society for Medical Oncology (ESMO) Congress and will be presented as an oral presentation in the Presidential Symposium format (Abstract Number: LBA5). The OptiTROP-Lung04 study was designed to evaluate the efficacy and safety of sacituzumab govitecan (sac-TMT) monotherapy at 5mg/kg intravenously every two weeks (Q2W) compared to pemetrexed plus platinum therapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who failed EGFR-TKI treatment.

In March 2025, sacituzumab govitecan (sac-TMT) had already received NMPA approval for treating EGFR gene mutation-positive locally advanced or metastatic non-squamous NSCLC patients who progressed after both EGFR-TKI and platinum-based chemotherapy treatment. Compared to standard treatment, sacituzumab govitecan (sac-TMT) monotherapy significantly extended overall survival for this patient population.

Additionally, another Phase III registration study evaluating sacituzumab govitecan (sac-TMT) in combination with osimertinib as first-line treatment for EGFR-mutated locally advanced or metastatic non-squamous NSCLC has completed full patient enrollment in China.