Clinical Summary:

• Design/Population: The phase 3 WU-KONG28 trial assessed sunvozertinib in previously untreated patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations. 
• Key Outcomes: Sunvozertinib significantly improved progression-free survival compared with chemotherapy and produced higher objective response rates and longer duration of response.
• Clinical Relevance: These findings support sunvozertinib as a potential first-line treatment option in this patient population. 

Results from the phase 3 WU-KONG28 trial demonstrated that sunvozertinib significantly improved progression-free survival (PFS) compared with platinum-based chemotherapy among previously untreated patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.

These results were presented by John Heymach, MD, PhD, MD Anderson Cancer Center, Houston, Texas, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

In this study, 324 patients were randomized 1:1 to receive 300 mg of once daily sunvozertinib (n = 163) or AUC5 carboplatin plus 500 mg/m² of pemetrexed once every 3 weeks for up to 6 cycles followed by pemetrexed maintenance (n = 161). Patients in the chemotherapy arm were permitted to cross over to sunvozertinib upon confirmed disease progression. The primary end point was PFS. Secondary end points included overall survival (OS), objective response rate (ORR), duration of response, and safety.

At analysis, median PFS was 10.3 months in the sunvozertinib arm and 7.5 months in the chemotherapy arm (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.50 to 0.85; P = .0008). Confirmed ORR was 58.9% and 31.1%, respectively. Median duration of response was 11.2 months in the sunvozertinib arm and 7.1 months in the chemotherapy arm. OS data remained immature. Among patients in the chemotherapy arm, 90.2% of patients crossed over to receive sunvozertinib. 

Safety was consistent with prior findings. Treatment-emergent adverse events leading to treatment discontinuation were reported in 7.4% of patients. No fatal treatment-emergent adverse events were reported. 

As Dr Heymach concluded, “these results support sunvozertinib as a first-line treatment for advanced NSCLC harboring EGFR exon20ins.” 

Source:

Heymach J, Liu G, Xing L, et al. Sunvozertinib monotherapy versus platinum-based chemotherapy as first-line treatment for advanced NSCLC with EGFR exon20ins: Primary analysis of a multinational phase 3 randomized study (WU-KONG28). Presented at the ASCO Annual Meeting. May 29 - June 2, 2026. Chicago, Illinois. LBA8500.