In this international phase 3 trial, first-line sunvozertinib significantly improved progression-free survival and objective response rate compared to carboplatin-pemetrexed chemotherapy in patients with advanced NSCLC harboring EGFR exon 20 insertion mutations. Although grade 3 or higher adverse events were more frequent with sunvozertinib, the treatment discontinuation rate was similar between groups. Overall survival was similar at the time of analysis but data were immature due to crossover.
Study
|
Phase 3, international, randomized, multicenter trial [WU-KONG28] |
| Advanced, untreated nonsquamous NSCLC with EGFR exon 20 insertions |
| Sunvozertinib (n=163) vs Carboplatin-Pemetrexed chemotherapy (n=161)
|
Efficacy
|
ORR: 58.9% vs 31.1% |
| mPFS: 10.3 mos vs 7.5 mos (HR 0.65 [0.50-0.85]) |
| 12-mo PFS: 46.1% vs 26.7% |
| mDoR: 11.2 mos vs 7.1 mos |
| mOS: 29.8 mos vs 28.8 mos (HR 0.99 [0.70-1.40])
|
Safety
|
Grade >=3 AEs: increased serum creatine kinase (21% vs 0.7%), diarrhea (14.1% vs 0%), anemia (9.2% vs 11.3%), neutropenia (2.5% vs 18.7%), thrombocytopenia (2.5% vs 6.7%) |
| Serious adverse events: 45.4% vs 26.7% |
| Treatment discontinuation due to AEs: 11.7% vs 12.0% |
| Treatment-related deaths: 0% vs 0.7%
|
N Engl J Med 2026; Published online May 29
Zhou C, Greillier L, Liu G First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations
http://doi.org/10.1056/NEJMoa2604461
Reviewed by Ulas D. Bayraktar, MD on Jun 13, 2026
