# Dizal Announces Phase 3 WU-KONG28 Results: ZEGFROVY® (Sunvozertinib) Outperforms Platinum-Doublet Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer - Link: https://www.thailand-business-news.com/pr-news/dizal-announces-phase-3-wu-kong28-results-zegfrovy-sunvozertinib-outperforms-platinum-doublet-chemotherapy-in-first-line-egfr-exon-20-insertion-mutation-positive-non-small-cell-lung-cancer - Published: 2026-05-29T19:52:00+07:00 - Author: PR Newswire | | ◦ _ZEGFROVY__^(®)__ demonstrated superior anti-tumor efficacy compared to platinum- doublet chemotherapy as a first-line treatment for advanced NSCLC with EGFR exon20ins_ ◦ _WU-KONG28 is the first global randomized phase 3 study with positive results for an oral, chemo-free, targeted monotherapy regimen in first-line EGFR exon20ins NSCLC_ ◦ _Late-breaking data were presented at the 2026 ASCO Annual Meeting and simultaneously published in _**_The New England Journal of Medicine_** SHANGHAI, May 29, 2026 /PRNewswire/ — Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, today announced 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) Annual Meeting and simultaneously published in **_The New England Journal of Medicine (The NEJM)_**. 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 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.  **About Dizal** Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with multiple assets in global pivotal studies and two leading assets: ZEGFROVY, approved in both the U.S. and China, and golidocitinib, approved in China. To learn more about Dizal, please visit [www.dizalpharma.com](http://www.dizalpharma.com/), or follow us on [LinkedIn](http://www.linkedin.com/company/dizal-pharma) or [X](https://twitter.com/Dizal_Global). **Forward-Looking Statements** This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", " believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal’s competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect. **Contacts** Investor Relations: [ir@dizalpharma.com](https://www.thailand-business-news.com/pr-news/ir@dizalpharma.com) Business Development: [bd@dizalpharma.com](https://www.thailand-business-news.com/pr-news/bd@dizalpharma.com) Media Contact: [pr@dizalpharma.com](https://www.thailand-business-news.com/pr-news/pr@dizalpharma.com) --- | This article was produced by Cision PR Newswire, our trusted news partner. The views expressed and the content presented here are solely those of the author and may not fully reflect the opinions of Thailand Business News. | --- **Read the original article :** [Dizal Announces Phase 3 WU-KONG28 Results: ZEGFROVY® (Sunvozertinib) Outperforms Platinum-Doublet Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer ](http://www.prnasia.com/story/archive/4971135_CN71135_0?rand=184833)