China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its drug candidate SKB264. The antibody-drug conjugate (ADC) targets trophoblast cell-surface antigen 2 (TROP2) and will be evaluated in combination with AstraZeneca’s (AZ, NASDAQ: AZN) Tagrisso (osimertinib) for the first-line treatment of EGFR-mutant non-small cell lung cancer (NSCLC).
Mechanism and Clinical Development
As an ADC, SKB264 delivers a cytotoxic payload directly to tumor cells by targeting the TROP2 antibody. This approach aims to reduce off-target toxicity while enhancing efficacy and safety. SKB264 is currently undergoing Phase II and III clinical trials for multiple tumor types globally, based on promising preliminary data. In May 2022, the drug was licensed to Merck, Sharp & Dohme (MSD, NYSE: MRK) in a USD 1.41 billion deal for commercial rights outside of Greater China.
Tagrisso’s Market Presence
Tagrisso, an irreversible third-generation EGFR-TKI with clinical activity against central nervous system metastasis, was approved in China in March 2017 for the treatment of metastatic NSCLC. It was included on the National Reimbursement Drug List (NRDL) in 2018, with its status renewed in 2020 for the coverage of the first-line indication. This approval underscores Tagrisso’s significant role in the treatment of EGFR-mutant NSCLC.
Future Outlook
The approval for the Phase II study of SKB264 in combination with Tagrisso highlights Kelun-Biotech’s commitment to advancing innovative treatments for lung cancer. With a robust clinical program and strategic partnerships, Kelun-Biotech is poised to make a meaningful impact on patient outcomes in EGFR-mutant NSCLC. The ongoing trials and commercial partnerships position SKB264 as a potential new treatment option for patients with significant unmet needs.-Fineline Info & Tech
