Chinese biopharmaceutical company Dizal (SSE:688192) announced on Saturday that its multinational Phase 3 WU-KONG28 study evaluating ZEGFROVY (sunvozertinib) monotherapy as first-line treatment in non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (exon20ins) met its primary endpoint with positive topline results.

The findings suggest that ZEGFROVY monotherapy has the potential to become the first and only chemo free, oral agent to treat newly diagnosed NSCLC patients with EGFR exon20ins.

WU-KONG28 is a multinational, open-label, randomised 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 16 countries and regions in Asia, Europe, North America and South America. Primary endpoint is progression-free survival (PFS) assessed by blinded independent central review (BICR).

Topline results demonstrated that ZEGFROVY significantly improved PFS compared to platinum-based doublet chemotherapy, with meaningful clinical benefit. Detailed data from the primary analysis will be submitted for presentation at an upcoming international scientific congress.