Shots:
Dizal has reported the topline P-III (WU-KONG28) trial data assessing Zegfrovy monotx. (QD, PO) vs Pt-based CT as the 1L treatment of pts with advanced NSCLC harboring EGFR exon 20 insertion mutations across Asia, EU, North America & South America
The trial met its 1EP of improved PFS, assessed by BICR, plus showed superiority across…
Shots:
The US FDA has granted accelerated approval to Zegfrovy for locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in pts whose disease has progressed on or after Pt-based CT
Approval was based on the multinational WU-KONG1 part B trial assessing Zegfrovy in above mentioned pts, which showed significant improvement…
Shots:
Dizal has completed pts enrollment in P-III (WU-KONG28) trial of sunvozertinib as a 1L treatment of NSCLC harboring EGFR exon 20 insertion mutations (exon20ins); NDA under the US FDA’s priority review (PDUFA: Jul 7, 2025)
Trial assessed sunvozertinib vs Pt-based doublet CTs in treatment-naïve NSCLC pts with EGFR exon20ins across 16 countries & regions…

