Dizal's ZEGFROVY® (Sunvozertinib) Shows Profound Antitumor Activity as First-Line Treatment in Advanced NSCLC Patients with PACC or Other Uncommon Mutations at ELCC 2026
Dizal's ZEGFROVY® (Sunvozertinib) Shows Profound Antitumor Activity as First-Line Treatment in Advanced NSCLC Patients with PACC or Other Uncommon Mutations at ELCC 2026 |
| [27-March-2026] |
First-line ZEGFROVY® monotherapy demonstrated an objective response rate (ORR) of 81.3% in patients with advanced NSCLC harboring EGFR PACC or other uncommon mutations, with a manageable safety profile SHANGHAI, March 27, 2026 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, today announced the presentation of new clinical data for ZEGFROVY® (sunvozertinib) as a first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) P-Loop and αC-helix compressing (PACC) or other uncommon mutations. The data were presented at the 2026 European Lung Cancer Congress (ELCC), held in Copenhagen, Denmark from March 25 to 28 (#44P).
PACC mutations account for approximately 12.5% of all EGFR mutations. Approved EGFR kinase inhibitors may have clinical activities to certain types of mutations, but overall, their clinical benefits are rather limited, and chemo doublet are the only option. Multiple studies have shown that patients with these mutations exhibit poorer prognosis than those with classical EGFR common mutations (exon 19 deletions and L858R), underscoring a significant unmet medical need for effective, well-tolerated therapies with broader activity cross the EGFR mutation spectrum. ZEGFROVY, a rationally designed oral EGFR TKI, has demonstrated robust clinical efficacy in advanced NSCLC and potent antitumor activity in preclinical models of EGFR PACC-mutant tumors. At the recommended phase 3 dose (RP3D) of 300 mg, ZEGFROVY monotherapy demonstrated promising antitumor activity and a manageable safety profile in treatment-naïve patients with advanced NSCLC harboring EGFR PACC or other uncommon mutations.
Dr. Xiaolin Zhang, CEO of Dizal, said: "NSCLC patients with EGFR PACC and other uncommon mutations represent a population with substantial unmet medical need, given the limited availability of effective and well-tolerated target therapies, compared to those available for classical EGFR mutations. The data presented at ELCC further reinforces the potential of ZEGFROVY to address this gap. We are committed to advancing our clinical development programs, with the goal of bringing transformative treatment options to the global lung cancer community as quickly as possible." ZEGFROVY is approved in the U.S. and China for the treatment of relapsed or refractory NSCLC with EGFR exon20ins. Recently, Dizal reported the results from the randomized Phase 3 WU-KONG28 study, comparing ZEGFROVY monotherapy with platinum containing chemo doublet. ZEGFROVY showed a statistically significant and clinically meaningful improvement in PFS in newly diagnosed patients with EGFR exon20ins. Detailed results will be presented at the upcoming scientific conference. 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 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. WU-KONG28, a multinational, randomized Phase 3 study conducted across 16 countries and regions evaluating ZEGFROVY as first-line treatment for patients with EGFR exon20ins NSCLC, met its primary endpoint. Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology. 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, or follow us on Linkedin or X. 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
SOURCE Dizal | ||
Company Codes: Shanghai:688192 |
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