China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented compelling efficacy and safety data for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, at the European Society for Medical Oncology (ESMO) Congress 2023. The drug is being evaluated for first-line treatment in advanced non-small cell lung cancer (NSCLC) with EGFR Exon20ins mutation, showcasing significant therapeutic potential.
Study Details and Results
The summary analysis included data from EGFR exon20ins mutant advanced NSCLC patients in the global multicenter I/II study “Wukong 1” (WU-KONG1) and the Phase II study “Wukong 15” (WU-KONG15). As of September 15, 2023, the efficacy analysis comprised 28 patients, while the safety analysis included 57 patients. The results were striking, with 100% of target lesions observed to have shrunk in the 28 patients included in the efficacy analysis. The objective response rate (ORR) reached an impressive 78.6%, and the median progression-free survival (mPFS) was 12.4 months in the 300mg group, surpassing previous research benchmarks.
Sunvozertinib’s Therapeutic Profile
Sunvozertinib, as a monotherapy, demonstrated strong and long-lasting anti-tumor activity, showing efficacy across multiple EGFR exon20ins mutation subtypes. The drug also exhibited good tolerability, with its overall safety profile aligning with previous second/later line reports and being similar to traditional EGFR-TKIs.
Regulatory Milestone
In August of this year, sunvozertinib received approval in China for the treatment of locally advanced or metastatic NSCLC with EGFR Exon20ins mutation in patients previously treated with platinum chemotherapy or intolerant of platinum. It stands as the first and currently only home-grown Category 1 drug with this indication in the country, marking a significant achievement for Dizal Pharmaceutical.-Fineline Info & Tech
