China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving the green light from EU authorities to proceed with the global, multi-center, random-controlled Phase III WU-KONG28 study for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib (DZD9008). The study aims to assess the drug as a first-line treatment for advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor 20 exon insertion (EGFR Exon20ins) mutations.
Sunvozertinib: A Pioneering Treatment for EGFR Exon20ins Mutant NSCLC
Sunvozertinib, the first home-grown Category 1 drug targeting EGFR exon20ins mutant advanced NSCLC, was awarded priority review status in China in January 2023. This recognition underscores the drug’s potential in addressing a critical unmet medical need. Dizal has published the latest data from two studies focusing on sunvozertinib’s efficacy in patients with EGFR exon20ins mutant advanced NSCLC who have failed previous chemotherapy. The objective response rate (ORR) was confirmed at 60.8%, while the best overall response (BoR) in patients treated with first-line single agent RP2D (300mg QD) reached 77.8%.
Implications of the EU Approval and Study Outcomes
The EU’s approval to conduct the Phase III WU-KONG28 study further validates sunvozertinib’s potential as a groundbreaking treatment option for patients with EGFR Exon20ins mutations. The positive data from the preliminary studies, along with the EU’s greenlight, positions Dizal Pharmaceutical to potentially transform the treatment landscape for this specific NSCLC patient population.-Fineline Info & Tech
