On March 21, 2026 Dizal (SSE:688192) reported 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.
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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).
About ZEGFROVY(sunvozertinib)
ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication.
In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins.
ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.
WU-KONG28, a multinational, randomized Phase 3 study conducted across 16 countries and regions evaluating ZEGFROVY as first-line treatment for patients with EGFR exon20ins NSCLC, met its primary endpoint.
Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology.
(Press release, Dizal Pharma, MAR 21, 2026, View Source;302721366.html [SID1234663805])