KOL Leaders Discussing WU-KONG28
Key Slides & Data
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WU-KONG28 Overview
WU-KONG28 (NCT05668988) is the first multinational, confirmatory Phase 3 randomized trial evaluating oral sunvozertinib monotherapy against platinum-pemetrexed chemotherapy as first-line treatment for advanced non-squamous NSCLC harboring EGFR exon 20 insertion mutations — a population historically underserved by classical EGFR TKIs. At ASCO 2026 (abstract LBA8500), the trial met its primary endpoint of blinded independent central review–assessed progression-free survival, with results published simultaneously in the New England Journal of Medicine. Sunvozertinib already holds FDA accelerated approval for previously treated EGFR exon20ins NSCLC and FDA Breakthrough Therapy Designation in the first-line setting; WU-KONG28 is the confirmatory study supporting potential first-line use.
Population
Treatment-naïve stage IIIB/IIIC/IV non-squamous NSCLC with confirmed EGFR exon 20 insertion mutations.
Intervention
Oral sunvozertinib 300 mg once daily vs carboplatin/pemetrexed with optional pemetrexed maintenance.
Primary Endpoint
Progression-free survival by blinded independent central review (RECIST 1.1).
Key Secondary
Overall survival, objective response rate (ORR), and duration of response (DOR).
Reported Results
Progression-Free Survival (Primary Endpoint)
Sunvozertinib significantly improved median PFS to 10.3 months vs 7.5 months for chemotherapy (HR 0.65; 95% CI, 0.50–0.85; p=0.0008). The 12-month PFS rate was 46.1% vs 26.7%.
Median PFS 10.3 vs 7.5 mo · HR 0.65Source: NEJM (LBA8500, ASCO 2026)Objective Response Rate
Confirmed ORR was 58.9% with sunvozertinib vs 31.1% with chemotherapy, with responses observed across exon 20 insertion variant subtypes.
ORR 58.9% vs 31.1%Source: NEJM (LBA8500, ASCO 2026)Overall Survival
Overall survival data were immature at this analysis. KOLs (e.g. @JacobPlieth) noted that crossover from the chemotherapy arm to sunvozertinib may confound the OS signal — an important interpretive caveat to watch as the data mature.
Source: ASCO 2026 presentation (LBA8500)Safety & Tolerability
Sunvozertinib was administered as an all-oral, chemotherapy-free regimen. Full adverse-event profiles from the Phase 3 dataset are reported in the NEJM publication; diarrhea and skin-related events are the class-typical EGFR-TKI toxicities discussed by KOLs. CNS coverage in monotherapy was raised as an open question (@TejasPatilMD).
Source: NEJM (LBA8500, ASCO 2026)