Shanghai, China | March 21, 2026
Dizal has announced positive topline results from its multinational Phase 3 WU-KONG28 clinical trial, demonstrating that ZEGFROVY® (sunvozertinib) significantly improves outcomes in patients with first-line non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (exon20ins). The study successfully met its primary endpoint of progression-free survival (PFS), showing statistically significant and clinically meaningful improvement compared to platinum-based chemotherapy, positioning ZEGFROVY as a potential first-in-class, chemo-free targeted therapy for this challenging cancer subtype.
Phase 3 Trial Demonstrates Superior Clinical Outcomes
The WU-KONG28 trial, a randomized, open-label, global Phase 3 study conducted across 16 countries and regions, evaluated ZEGFROVY monotherapy against platinum-containing chemotherapy doublets in treatment-naïve patients. The results confirmed that ZEGFROVY significantly prolonged progression-free survival (PFS), as assessed by blinded independent central review, highlighting a clear clinical advantage over standard chemotherapy regimens.
In addition to the primary endpoint, the therapy demonstrated superior performance across all key secondary endpoints, including confirmed objective response rate (cORR), duration of response (DOR), and disease control rate (DCR). These findings underscore the drug’s robust anti-tumor activity and durable clinical benefit, reinforcing its potential to become a new standard-of-care first-line treatment for patients with EGFR exon20ins NSCLC.
Chemo-Free Targeted Therapy Advances Precision Oncology
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ZEGFROVY is an oral, once-daily, irreversible EGFR inhibitor designed to target a wide spectrum of EGFR exon 20 insertion mutations, which are known for their genetic heterogeneity and resistance to conventional therapies. The success of the WU-KONG28 trial represents the first Phase 3 evidence demonstrating meaningful clinical benefit with a chemo-free, targeted therapy in this patient population, marking a major shift in treatment paradigm.
Traditional treatment options for EGFR exon20ins NSCLC have relied heavily on platinum-based chemotherapy, often associated with toxicity and limited efficacy. By offering a targeted, oral alternative, ZEGFROVY has the potential to improve patient convenience, reduce treatment burden, and enhance overall quality of life, aligning with the principles of precision medicine and personalized oncology care.
Favorable Safety Profile and Regulatory Outlook
The study also demonstrated that ZEGFROVY was generally well tolerated, with a safety profile consistent with previous clinical studies. Most treatment-emergent adverse events were Grade 1 or 2 and manageable, supporting its suitability for long-term use in the first-line setting.
ZEGFROVY is already approved in both the United States and China for previously treated NSCLC patients with EGFR exon20ins, and has received Breakthrough Therapy Designations for first-line treatment. Based on these positive Phase 3 results, Dizal plans to engage with regulatory authorities regarding potential new drug applications (NDAs) to expand its indication.
From a cGxP perspective, the WU-KONG28 trial highlights the importance of robust clinical trial design, global patient enrollment, and adherence to Good Clinical Practice (GCP) standards, ensuring high-quality data integrity and regulatory readiness for submission.
The Phase 3 WU-KONG28 trial establishes ZEGFROVY as a promising first-line targeted therapy for EGFR exon20ins NSCLC, delivering significant improvements in progression-free survival, strong secondary endpoint outcomes, and a favorable safety profile. With its potential to become the first chemo-free oral therapy in this indication, ZEGFROVY represents a major advancement in lung cancer treatment and precision oncology, offering new hope for patients with limited therapeutic options.
Source: Dizal press release
