• Treatment with ZEGFROVY^® resulted in statistically significant and clinically meaningful improvement in progression free survival (PFS) over platinum-containing chemo doublet
• WU-KONG 28 is the first and only phase 3 study to demonstrate meaningful benefits with an oral, once daily, chemo-free, targeted therapy
• In addition to improvement in PFS, ZEGFROVY^® also showed superior results in all secondary endpoints, including cORR, DOR, DCR, compared to platinum-based chemo doublet
• ZEGFROVY^® was generally well tolerated with a safety profile consistent with previous studies  

Dizal announced that its multinational Phase 3 WU-KONG28 study evaluating ZEGFROVY^® (sunvozertinib) monotherapy as first-line treatment in non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (exon20ins) met its primary endpoint with positive topline results.

The findings suggest that ZEGFROVY monotherapy has the potential to become the first and only chemo free, oral agent to treat newly diagnosed NSCLC patients with EGFR exon20ins.

WU-KONG28 is a multinational, open-label, randomized confirmatory phase 3 study evaluating ZEGFROVY versus platinum-based chemotherapy as first-line treatment in advanced NSCLC patients with EGFR exon20ins. The study enrolled patients across 16 countries and regions in Asia, Europe, North America and South America. The primary endpoint is progression-free survival (PFS) assessed by blinded independent central review (BICR). Topline results demonstrated that ZEGFROVY significantly improved PFS compared to platinum-based doublet chemotherapy, with meaningful clinical benefit. Detailed data from the primary analysis will be submitted for presentation at an upcoming international scientific congress.

"Finding a drug targeting EGFR exon 20 insertion mutations is especially challenging due to their enormous heterogeneity. We have identified over 100 different subtypes of EGFR exon20ins clinically. Despite tremendous efforts, there is no success yet in finding an effective target drug that can spare patients from chemotherapies. WU-KONG28 study has the potential to change all that." said Dr. Xiaolin Zhang, CEO of Dizal. "The success of this multinational pivotal study further validates ZEGFROVY's potential as first-line therapy for patients with EGFR exon20ins NSCLC. We extend our sincere gratitude to the patients, their families, and the investigators worldwide for their dedication and contribution to this study. We look forward to sharing comprehensive data with the global scientific community."

"The positive topline results from WU-KONG28 study represent an important advancement for treating patients with EGFR exon20ins NSCLC," said Prof. Caicun Zhou, MD, PhD of Shanghai East Hospital and the principal investigator of the study. "ZEGFROVY is currently the only single-agent, small-molecule targeted therapy approved in both China and the United States for patients with EGFR exon 20 insertion NSCLC. In this Phase 3 trial, first-line treatment with ZEGFROVY significantly prolonged PFS compared to platinum-based doublet chemotherapy. These results suggest that ZEGFROVY may offer an effective and convenient treatment option for treatment-naïve patients with EGFR exon20ins NSCLC."

ZEGFROVY was previously approved in both China and the U.S. for the treatment of relapsed or refractory NSCLC with EGFR exon20ins. In the first-line setting, ZEGFROVY has been granted Breakthrough Therapy Designations by both the U.S. Food and Drug Administration (FDA) and China Center for Drug Evaluation (CDE). Based on WU-KONG28 study results, Dizal plans to engage with regulatory authorities regarding potential new drug applications (NDAs).