Dizal's Zegfrovy Achieves Phase 3 Success in First-Line NSCLC with EGFR Exon 20 Insertion, Challenging Chemotherapy Standard

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Dizal announced on March 21, 2026, that its Phase 3 WU-KONG28 study met its primary endpoint, with Zegfrovy (sunvozertinib) significantly improving progression-free survival (PFS) versus platinum-based doublet chemotherapy in first-line treatment for advanced NSCLC patients with EGFR exon 20 insertion mutations.12

The multinational, open-label, randomized trial enrolled patients across 16 countries in Asia, Europe, North America, and South America, with PFS assessed by blinded independent central review.12

Zegfrovy also showed superior results in secondary endpoints including confirmed objective response rate (cORR), duration of response (DOR), and disease control rate (DCR), and was generally well-tolerated.2

Previously approved in China and the US for relapsed/refractory NSCLC with EGFR exon20ins, Zegfrovy has Breakthrough Therapy Designations for first-line use; Dizal plans regulatory submissions based on these results.12

This marks the world-first Phase 3 win for an oral targeted therapy in this rare NSCLC subtype, potentially challenging chemotherapy standards and positioning it against competitors like J&J's Rybrevant.35

Sources:

1. https://www.investing.com/news/company-news/dizals-lung-cancer-drug-meets-primary-goal-in-phase-3-trial-93CH-4574052

2. https://www.biospace.com/press-releases/dizal-announces-positive-topline-phase-3-results-from-wu-kong28-study-evaluating-oral-once-daily-zegfrovy-sunvozertinib-vs-platinum-containing-chemo-doublet-in-first-line-non-small-cell-lung-cancer-nsclc-with-egfr-exon-20-insertion-mutation-exon20ins

3. https://www.ainvest.com/news/zegfrovy-phase-3-win-challenges-chemo-line-standard-egfr-exon20-nsclc-2603/

5. https://insights.citeline.com/scrip/scrip/r-and-d/clinical-trials/dizals-zegfrovy-snags-world-first-phase-iii-win-as-oral-option-for-rare-type-nsclc-UQNFPNOWFFAD7E2KUJBY2MXO2Y/