Dizal announced 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).

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) 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.