SHANGHAI, China, May 29, 2026
Dizal has announced groundbreaking results from the global Phase 3 WU-KONG28 trial, demonstrating that ZEGFROVY® (sunvozertinib) significantly outperformed standard platinum-doublet chemotherapy as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (EGFR exon20ins). The landmark findings were presented as a Late-Breaking Abstract at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine, highlighting the study’s major clinical significance. The results mark the first positive global Phase 3 trial of an oral, chemotherapy-free targeted monotherapy regimen in the first-line EGFR exon20ins NSCLC setting and could potentially redefine treatment standards for a patient population that has historically faced limited targeted therapeutic options.
WU-KONG28 Demonstrates Superior Progression-Free Survival
The multinational WU-KONG28 study enrolled 324 previously untreated patients with advanced NSCLC carrying EGFR exon20 insertion mutations across 15 countries and regions worldwide. Participants were randomized to receive either ZEGFROVY 300 mg once daily or standard platinum-doublet chemotherapy. The trial successfully met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients receiving ZEGFROVY.
According to blinded independent central review, median PFS reached 10.3 months in the ZEGFROVY arm compared with 7.5 months in the chemotherapy group, representing a 35% reduction in the risk of disease progression or death. These findings establish ZEGFROVY as the first targeted oral monotherapy to show superior efficacy over chemotherapy in this challenging molecular subtype of lung cancer. Investigators noted that patients with EGFR exon20ins mutations have historically lacked effective first-line targeted therapies and have largely depended on conventional chemotherapy despite its associated toxicity and limited durability of response. The WU-KONG28 results provide compelling evidence supporting a shift toward precision medicine-based treatment strategies for this underserved patient population.
Significant Response Rates Support Chemotherapy-Free Treatment
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Beyond improvements in progression-free survival, ZEGFROVY delivered substantially stronger anti-tumor activity compared with chemotherapy across several key efficacy measures. The study reported a best objective response rate (ORR) of 68.1% among patients treated with ZEGFROVY, nearly double the 35.4% response rate observed in the chemotherapy arm. Additionally, patients receiving ZEGFROVY experienced a median duration of response of 11.2 months, compared with 7.1 months for chemotherapy-treated patients.
These findings indicate that patients receiving the targeted therapy were more likely to experience meaningful tumor shrinkage and maintain those responses for longer periods. The ability to deliver strong efficacy without the need for cytotoxic chemotherapy represents an important advancement in patient care, offering the potential for improved quality of life while reducing treatment burden. Researchers emphasized that the combination of efficacy, convenience, and oral administration could significantly influence future treatment decisions for newly diagnosed EGFR exon20ins-positive NSCLC patients worldwide.
ZEGFROVY Advances Precision Oncology in Lung Cancer
ZEGFROVY is an irreversible EGFR inhibitor specifically designed to target a broad range of EGFR mutations while maintaining selectivity against wild-type EGFR. The therapy has already received approvals in both the United States and China for patients with previously treated EGFR exon20ins-positive NSCLC. The positive WU-KONG28 results now support expansion into the first-line setting and further strengthen the drug’s clinical profile.
Importantly, the safety findings from WU-KONG28 remained consistent with previous studies, with treatment-related adverse events generally manageable and reversible. No new safety concerns were identified during the trial. Based on the strength of the Phase 3 data, China’s National Medical Products Administration (NMPA) has accepted Dizal’s supplemental New Drug Application and granted Priority Review status for first-line use of ZEGFROVY. As precision oncology continues transforming lung cancer treatment, the WU-KONG28 study represents a major milestone that could usher in a new chemotherapy-free era for patients with EGFR exon20 insertion mutation-positive NSCLC, offering a more effective and targeted therapeutic option with the potential to improve long-term outcomes worldwide.
Source: Dizal press release
