Dizal Sunvozertinib Outperforms Chemo, Reshapes First-Line NSCLC Dizal's Sunvozertinib met primary endpoint. Phase 3 WU-KONG28 trial succeeded. Drug showed superior anti-tumor efficacy. PFS prolonged versus chemotherapy. Dizal announced positive Phase 3 WU-KONG28 results for Sunvozertinib (ZEGFROVY®). The trial evaluated Sunvozertinib as a first-line treatment for EGFR Exon20ins NSCLC. It demonstrated superior anti-tumor efficacy and prolonged progression-free survival (PFS) compared to platinum-doublet chemotherapy. This marks the first global randomized Phase 3 study to show positive results for an oral, chemo-free targeted monotherapy in this indication. This outcome positions Sunvozertinib for potential accelerated approval pathways. The FDA and EMA prioritize therapies addressing unmet medical needs. Dizal will likely submit these data for regulatory review soon. Such a strong Phase 3 result could support a New Drug Application (NDA) or Marketing Authorization Application (MAA). This aligns with 21 CFR Part 314 Subpart H for accelerated approval. EMA previously granted Orphan Drug Designation. This result impacts the competitive landscape. Sunvozertinib could become the new standard of care. Competitors like Takeda's Exkivity (mobocertinib) and Amgen's Lumakras (sotorasib) face increased pressure. This success could shift market share dramatically. Dizal anticipates presenting full data at a major medical conference in late 2026.