Dizal’s Phase III WU-KONG28 trial of Zegfrovy (sunvozertinib) for first-line treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) has met its primary endpoint.
The multinational study revealed positive topline data and demonstrated that Zegfrovy improved progression-free survival (PFS) compared to platinum-based doublet chemotherapy.
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This randomised confirmatory, open-label trial enrolled patients across 16 countries and regions in Europe, Asia, South America, and North America.
The primary endpoint was PFS evaluated by blinded independent central review. Dizal noted that detailed data from the primary analysis will be submitted for presentation at an upcoming international scientific congress.
Zegfrovy was previously approved in both China and the US for relapsed or refractory NSCLC with EGFR exon20ins.
In the first-line setting, it has received breakthrough therapy designations from both the US Food and Drug Administration (FDA) and China Center for Drug Evaluation (CDE). Dizal plans to engage regulatory authorities regarding potential new drug applications based on these results.
Zegfrovy is described as an irreversible EGFR inhibitor targeting a range of EGFR mutations with wild-type selectivity.
Dizal CEO Dr Xiaolin Zhang said: “Finding a drug targeting EGFR exon 20 insertion mutations is especially challenging due to their enormous heterogeneity. We have identified over one hundred 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.”
“The success of this multinational pivotal study further validates Zegfrovy’s potential as first-line therapy for patients with EGFR exon20ins NSCLC.”
In June 2025, Dizal completed subject enrolment for the randomised Phase III WU-KONG28 trial of oral sunvozertinib for treating NSCLC patients.
