Dizal Pharmaceuticals’ sunvozertinib outperformed chemotherapy in a Phase 3 trial for first-line treatment of advanced NSCLC with EGFR exon 20 insertion mutations, extending progression-free survival versus carboplatin–pemetrexed. The randomized study enrolled 324 patients and used blinded independent central review as the primary endpoint. Median progression-free survival was 10.3 months with sunvozertinib compared with 7.5 months for chemotherapy, with a hazard ratio of 0.65 (P<0.001). At 12 months, progression-free survival was reported in 46.1% of patients in the sunvozertinib arm versus 26.7% in the chemotherapy arm; overall survival data were immature. The trial also reported higher objective response rates (58.9% vs. 31.1%) but increased grade 3 or higher adverse events (75.5% vs. 56.7%). The most common severe events included increased serum creatine kinase levels, diarrhea, and anemia, with no deaths attributed to treatment-related adverse events.
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