Dizal Pharmaceuticals’ sunvozertinib outperformed chemotherapy in a phase 3 first-line trial for advanced non–small-cell lung cancer with EGFR exon 20 insertion mutations. In NEJM-published results (WU-KONG28; NCT05668988), median progression-free survival was 10.3 months with sunvozertinib versus 7.5 months with carboplatin–pemetrexed, with a hazard ratio of 0.65. The trial also reported higher objective response rates in the sunvozertinib arm (58.9% vs 31.1%). However, the safety profile was heavier, with grade 3 or higher adverse events occurring in 75.5% versus 56.7% on chemotherapy; common severe events included increased creatine kinase, diarrhea, and anemia. With crossover allowed after progression, the phase 3 readout still provides direct comparative evidence in a biomarker-defined population. The results set up a likely shift in treatment sequencing for EGFR exon 20 insertion NSCLC, where targeted options have been limited.
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