Chinese biopharmaceutical company Dizal announced on Thursday the completion of patient enrolment for its WU-KONG28 clinical trial in non-small cell lung cancer (NSCLC).

WU-KONG28 is a multinational, randomised phase III study evaluating the efficacy and safety of sunvozertinib versus platinum-based doublet chemotherapies as a first-line treatment for NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). It is being conducted across 16 countries and regions in Asia, Europe, North America and South America.

Sunvozertinib, the only approved oral treatment for NSCLC patients with EGFR exon20ins, has demonstrated significant efficacy and a favourable safety profile in this patient population. Both the US 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.

Sunvozertinib is approved in China for the treatment of relapsed and refractory NSCLC with EGFR exon20ins. The FDA granted priority review for its NDA for the same indication with a PDUFA date of 7 July 2025.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine.