Dizal 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 China 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 exon20in. 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 Asia, Europe, North America, and South America. The primary endpoint and key secondary endpoint were independent review committee (IRC) assessed objective response rate (ORR) and duration of response (DoR) respectively.

As of March 22, 2024, a total of 111 patients were enrolled to receive sunvozertinib treatment at 300mg as the optimal recommended phase 2 dose (RP2D). 107 patients who met the full analysis set (FAS) definition were included in efficacy analysis, of which Asian, White, and Black or African American enrollees were 57.9%, 40.2% and 1.9%, respectively. The key findings of the primary analysis were as follows: Per IRC assessment, sunvozertinib achieved a best ORR of 53.3%.

The median DoR has not been reached, and the 9-month DoR rate was 57%, indicating durable efficacy of sunvozertinib. Anti-tumor efficacy was observed regardless of amivantamab treatment. The best ORRs in patients with or without prior amivantamab treatment were 50% and 53.8%, respectively.

Sunvozertinib was well tolerated with a favorable safety profile consistent with previous reports. WU-KONG28, a phase III, multinational, randomized study, is ongoing to assess sunvozertinib versus platinum-based doublet chemotherapy in the first-line setting with patients from 14 countries and regions in Asia, Europe, North America, and South America.