Dizal Reports Positive Phase 3 Sunvozertinib Results in NSCLC

Dizal has announced positive topline results from the multinational Phase 3 WU-KONG28 trial (NCT05668988) evaluating ZEGFROVY® (sunvozertinib) as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (exon20ins). The study met its primary endpoint, demonstrating that sunvozertinib significantly improved progression-free survival (PFS) compared with platinum-based doublet chemotherapy.

The findings suggest that ZEGFROVY monotherapy may become the first chemo-free, oral targeted therapy for newly diagnosed NSCLC patients with EGFR exon20ins mutations, a subgroup that remains difficult to treat due to the high heterogeneity of these alterations and the limited benefit observed with conventional EGFR tyrosine kinase inhibitors.

The WU-KONG28 trial is a multinational, open-label, randomized Phase 3 confirmatory study comparing ZEGFROVY with platinum-based chemotherapy as first-line treatment in patients with advanced NSCLC and EGFR exon20ins mutations. The trial enrolled patients across 16 countries and regions in Asia, Europe, North America, and South America.

The primary endpoint was progression-free survival assessed by blinded independent central review (BICR). According to the topline results, treatment with ZEGFROVY led to a clinically meaningful improvement in PFS compared with standard chemotherapy. Detailed results from the primary analysis are expected to be presented at an upcoming international scientific congress.

Dr. Xiaolin Zhang, CEO of Dizal, said targeting EGFR exon20 insertion mutations is challenging due to the large number of mutation subtypes, but the WU-KONG28 results highlight ZEGFROVY’s potential as a first-line treatment that could help patients avoid chemotherapy.

Principal investigator Prof. Caicun Zhou, MD, PhD, of Shanghai East Hospital, added that ZEGFROVY, already approved in China and the U.S. for previously treated EGFR exon20ins NSCLC, significantly improved progression-free survival over platinum-based chemotherapy in the Phase 3 trial, supporting its potential as a convenient first-line targeted therapy.

ZEGFROVY has previously been approved in both the United States and China for the treatment of locally advanced or metastatic NSCLC with EGFR exon20ins mutations in patients whose disease progressed after platinum-based chemotherapy. In the first-line setting, the therapy has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and a breakthrough therapy-like designation from China’s Center for Drug Evaluation (CDE). Based on the WU-KONG28 results, Dizal plans to engage with regulatory authorities regarding potential new drug applications (NDAs) to expand ZEGFROVY’s indication to first-line treatment of EGFR exon20ins NSCLC.

Sunvozertinib is an irreversible EGFR inhibitor designed to target a broad spectrum of EGFR mutations, including sensitizing mutations, T790M, uncommon EGFR variants, and EGFR/HER2 exon20 insertions, while maintaining selectivity for wild-type EGFR. Beyond EGFR exon20ins NSCLC, the drug has also shown encouraging anti-tumor activity in patients with these other EGFR and HER2 alterations.

Across clinical studies, ZEGFROVY has demonstrated a manageable safety profile, with most treatment-emergent adverse events reported as Grade 1 or 2 and considered clinically manageable.

Preclinical and clinical findings for sunvozertinib have been published in leading peer-reviewed journals, including Cancer Discovery, The Lancet Respiratory Medicine, and the Journal of Clinical Oncology.

Reference

Dizal Announces Positive Topline Phase 3 Results from WU-KONG28 Study: Evaluating Oral, Once-Daily ZEGFROVY® (Sunvozertinib) vs. Platinum-Containing Chemo Doublet in First-Line Non-Small Cell Lung Cancer (NSCLC) with EGFR Exon 20 Insertion Mutation (exon20ins), 21 March 2026, https://www.dizalpharma.com/news/detail?id=109&search=&currentPage=1

A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28), ClinicalTrials.gov ID NCT05668988, https://clinicaltrials.gov/study/NCT05668988