In a pivotal Phase 3 trial, sunvozertinib outperformed chemotherapy as first-line treatment in advanced non–small-cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The study randomized 324 patients 1:1 to sunvozertinib or carboplatin–pemetrexed, with progression-free survival assessed by blinded independent central review. Sunvozertinib delivered a median progression-free survival of 10.3 months versus 7.5 months for chemotherapy (hazard ratio 0.65, p<0.001). The objective response rate was 58.9% with sunvozertinib compared with 31.1% with chemotherapy, and at 12 months PFS was reported in 46.1% of patients versus 26.7% under chemotherapy. The safety profile included higher rates of grade 3 or worse adverse events for sunvozertinib (75.5% vs. 56.7%), with grade 3 or higher creatine kinase elevations, diarrhea, and anemia reported as common. No deaths were attributed to investigational drug-related adverse events. The results were published at NEJM.org following funding by Dizal Pharmaceuticals.