China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its sacituzumab tirumotecan (SKB264/MK-2870). The approval allows the use of this TROP2-targeted antibody drug conjugate (ADC) in adult patients with EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has progressed after treatment with EGFR tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy. This nod makes sacituzumab tirumotecan the world’s first approved ADC for lung cancer globally.
Clinical Trial Basis
The NMPA’s decision was based on results from the OptiTROP-Lung03 study, a multi-center, randomized, controlled pivotal study. The trial assessed the efficacy and safety of sacituzumab tirumotecan administered as a monotherapy at 5mg/kg every other week (Q2W) via intravenous injection, compared to docetaxel in patients with locally advanced or metastatic EGFR-mutant NSCLC who had failed previous treatment with an EGFR-TKI and platinum-based chemotherapy. The drug demonstrated statistically significant and clinically meaningful improvements in objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to docetaxel, as shown in a pre-specified interim analysis.
Licensing and Regulatory Status
In May 2022, sacituzumab tirumotecan was the subject of a licensing deal between Merck, Sharp & Dohme (MSD) for territories outside Greater China. It is the first home-grown ADC to receive full approval in China for use in adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies. Additionally, the drug is awaiting regulatory decisions in China for use as a monotherapy in patients with EGFR-mutant NSCLC who have failed after EGFR-TKI therapy.-Fineline Info & Tech
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