, /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, presented the latest data from the inaugural global pivotal study WU-KONG1 Part B (WU-KONG1B) of sunvozertinib in relapsed or refractory non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study demonstrated statistically significant outcomes on the primary endpoint for sunvozertinib and highlighted its significant clinical value to patients around the globe. As a rationally designed, oral, potent EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity, sunvozertinib was previously granted Breakthrough Therapy designations by both the US FDA and the China Center for Drug Evaluation (CDE) in treating NSCLC with EGFR exon20ins.
Sunvozertinib has obtained conditional approval in through a phase II pivotal study (WU-KONG6), making it the world's first and only oral drug for the treatment of NSCLC patients with EGFR exon20ins. WU-KONG1B, a multinational pivotal study, is the equivalent study with a similar design of WU-KONG6 to investigate sunvozertinib in relapsed or refractory NSCLC patients with EGFR exon20ins from 10 countries and regions in , , , and . The primary endpoint and key secondary endpoint were independent review committee (IRC) a.
