Sunvozertinib (EGFR exon20ins TKI) extends PFS vs carbo/pem chemo in 1L EGFR exon20ins NSCLC (WU-KONG28)

Sunvozertinib is an oral EGFR tyrosine kinase inhibitor designed to inhibit EGFR exon 20 insertion mutations, tested head-to-head vs platinum doublet in the confirmatory multinational Phase 3 WU-KONG28 trial (NCT05668988) in previously untreated advanced EGFR exon20ins NSCLC (n=324; 1:1 randomization; stratified by baseline brain metastases). At the Jan 16, 2026 data cutoff, BICR-assessed median PFS was 10.3 vs 7.5 months (HR 0.65, 95% CI 0.50–0.85; p=0.0008), with higher confirmed ORR (58.9% vs 31.1%) and longer DoR (11.2 vs 7.1 months); OS was immature with 90.2% crossover to sunvozertinib after BICR-confirmed progression in the chemo arm. Discontinuations from drug-related TEAEs were 7.4% on sunvozertinib, with no drug-related fatal TEAEs reported; efficacy vs the trial’s platinum/pemetrexed control looks directionally similar-to-better than historical chemo-alone outcomes in this biomarker subgroup, but it underperforms the PAPILLON first-line benchmark where amivantamab + carbo/pem delivered mPFS ~11.4 vs 6.7 months (HR ~0.40) against the same chemo backbone.