On June 19, 2025 Dizal reported the completion of patient enrollment for its WU-KONG28 clinical trial: a multinational, randomized phase III study evaluating the efficacy and safety of sunvozertinib versus platinum-based doublet chemotherapies as a first-line treatment for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) (Press release, Dizal Pharma, JUN 19, 2025, View Source [SID1234654007]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
EGFR exon20ins have been difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. Patients with EGFR exon20ins NSCLC face a poor prognosis and limited treatment options due to the limited efficacy of first- to third-generation EGFR tyrosine kinase inhibitors (TKIs).
Sunvozertinib, the only oral treatment for NSCLC patients with EGFR exon20ins approved, has demonstrated significant efficacy and a favorable safety profile in this patient population. Both the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) have granted Breakthrough Therapy designation to sunvozertinib for the treatment of EGFR exon20ins NSCLC.
WU-KONG28 is a phase III, multinational, randomized clinical trial investigating sunvozertinib compared to platinum-based doublet chemotherapies in treatment-naïve NSCLC patients with EGFR exon20ins. The study is being conducted across 16 countries and regions in Asia, Europe, North America, and South America.
At the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, Dizal reported that sunvozertinib, as a single oral agent, achieved 100% reduction of target lesions, a confirmed objective response rate (ORR) of 78.6%, and a median progression-free survival (mPFS) of 12.4 months, in treatment-naïve patients with advanced or metastatic NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated a well-tolerated safety profile compaired to other EGFR TKIs.
Sunvozertinib is approved in China for the treatment of relapsed and refractory NSCLC with EGFR exon20ins. U.S. FDA granted priority review for its NDA for the same indication with a PDUFA date of July 7, 2025.
About sunvozertinib (DZD9008)
Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.
Sunvozertinib 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.
Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.
Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine.