On May 29, 2026 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, reported the results from the multinational phase 3 WU-KONG28 study showing that ZEGFROVY (sunvozertinib) monotherapy demonstrated superior anti-tumor efficacy, compared to platinum-doublet chemotherapy, in untreated NSCLC patients with EGFR exon 20 insertion mutations (exon20ins). These data were presented as a Late-Breaking Abstract Oral Presentation (#LBA8500) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine (The NEJM).

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As of January 16, 2026, 324 patients were randomized in a 1:1 ratio to receive either ZEGFROVY or chemotherapy. ZEGFROVY, administered at 300 mg once daily, demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS), the primary endpoint of the study, as assessed by blinded independent central review (BICR). The overall safety profile was consistent with previous studies, no new safety finding.

Median PFS was 10.3 months with ZEGFROVY versus 7.5 months with chemotherapy (HR=0.65; P=0.0008).
BICR-assessed best objective response rate (BoR) was 68.1% with ZEGFROVY versus 35.4% with chemotherapy, and median duration of response (DoR) was 11.2 months versus 7.1 months.
The overall safety profile was consistent with previous studies, with adverse reactions generally manageable and reversible.
"Over the past two decades, treatment for EGFR-mutated NSCLC has evolved substantially, with targeted therapies transforming outcomes. However, patients with EGFR exon20ins NSCLC have continued to face limited treatment options, particularly in the first-line setting," said John Heymach, M.D., Ph.D, Chair of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, and presenting author. "The WU-KONG28 trial marks a clinical turning point. The data demonstrate that a single-agent targeted oral regimen can deliver superior antitumor efficacy over conventional chemotherapy, offering a practice-changing alternative that may spare treatment-naïve patients from initial cytotoxic treatment."

"The current first-line management of EGFR exon20ins NSCLC remains chemotherapy-bound, highlighting a substantial unmet need for a precision targeted therapy that simultaneously balances robust efficacy, favorable safety, and oral administration convenience," said Caicun Zhou, M.D., Ph.D, Shanghai East Hospital affiliated with Tongji University, Lead Principal Investigator of WU-KONG28, and corresponding author of The NEJM article. "The WU-KONG28 study demonstrates that ZEGFROVY monotherapy yields superior antitumor efficacy compared to platinum-doublet chemotherapy, while maintaining a manageable safety profile and enhanced convenience. These findings support the potential to usher the first-line treatment of EGFR exon20ins NSCLC into a chemotherapy-free era, providing global patients a more precise single-agent targeted therapeutic option."

"The presentation of WU-KONG28 as an ASCO (Free ASCO Whitepaper) Late-Breaking Abstract (LBA) and its simultaneous publication in The NEJM underscore the clinical significance and quality of the study," said Dr. Xiaolin Zhang, CEO of Dizal. "WU-KONG28 study demonstrates that ZEGFROVY can provide superior benefits for treatment naïve patients. It is the first positive study for this difficult disease, providing a chemotherapy-free option for patients globally. It is the first global phase 3 study conducted by Dizal. I am deeply grateful to our patients, their families, and investigators of the study. I am very proud of our team for this fantastic achievement."

ZEGFROVY has previously been granted accelerated approvals in both the U.S. and China for the treatment of relapsed or refractory EGFR exon20ins NSCLC. Based on the positive results of WU-KONG28, the New Drug Application (NDA) for ZEGFROVY as a first-line treatment for EGFR exon20ins NSCLC has been accepted and granted Priority Review designation by China’s National Medical Products Administration (NMPA).

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 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.

Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals including Cancer Discovery, The Lancet Respiratory Medicine, Journal of Clinical Oncology, and The New England Journal of Medicine.

About WU-KONG28

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 15 countries and regions in Asia, Europe, North America and South America. The primary endpoint is progression-free survival (PFS) assessed by BICR.

(Press release, Dizal Pharma, MAY 29, 2026, View Source [SID1234666226])