WU-KONG1B at a Glance
Design: Phase 2, open-label, multinational dose-optimization study (sunvozertinib 200 mg vs 300 mg once daily) in platinum-pretreated EGFR exon20ins NSCLC (NCT03974022).
Primary endpoint (confirmed ORR): ~46% by blinded independent review — 45.9% (200 mg), 47.2% (300 mg randomized), 45.8% (300 mg all-comers); P<.0001 (JCO 2025).
Duration of response: 11.1 months at 200 mg; 13.8 months at 300 mg (JCO 2025).
Hard-to-treat subsets: responses seen with baseline brain metastases and prior amivantamab.
Regulatory: FDA accelerated approval (Jul 2, 2025) in post-platinum EGFR exon20ins NSCLC; confirmatory trial = WU-KONG28 (first-line).
Sponsor / drug: sunvozertinib (Zegfrovy), Dizal — global rights licensed to AstraZeneca (Jul 2026).
KOL Leaders Discussing WU-KONG1B
Top Tweets
WU-KONG1B Data Slides (ASCO 2024)
What Is the WU-KONG1B Trial?
WU-KONG1B (WU-KONG1 Part B; NCT03974022) is the Phase 2, multinational pivotal study that established the efficacy of sunvozertinib in patients with advanced NSCLC harboring EGFR exon 20 insertion (exon20ins) mutations whose disease progressed after platinum-based chemotherapy. EGFR exon20ins is a rare, difficult-to-treat oncogenic driver that has historically been resistant to classic EGFR tyrosine kinase inhibitors, leaving these patients with limited options.
Sunvozertinib is an oral, irreversible EGFR inhibitor discovered by Dizal scientists that targets a broad spectrum of EGFR mutations while maintaining selectivity over wild-type EGFR. WU-KONG1B enrolled a globally representative population — more than 40% of patients were non-Asian — and the trial's confirmed objective response rate became the basis for sunvozertinib's US accelerated approval, making it the first oral targeted therapy for this population.
Study Design & Population
Design
Phase 2, open-label, multinational. Patients randomized 1:1 to sunvozertinib 200 mg or 300 mg once daily; additional patients enrolled at 300 mg after a predefined interim analysis. (JCO 2025)
Population
Advanced/metastatic EGFR exon20ins NSCLC with prior platinum-based chemotherapy. Baseline brain metastases and prior amivantamab were permitted; ~40% of enrollees were non-Asian. (JCO 2025)
Endpoints
Primary: blinded independent review committee (IRC)-assessed confirmed ORR per RECIST v1.1. Key secondary: duration of response (DoR). (JCO 2025)
Trial Details
NCT03974022. Sponsor: Dizal Pharmaceutical. Lead principal investigator: Prof. James Chih-Hsin Yang (National Taiwan University). Biomarker: EGFR exon20ins by an FDA-authorized test.
Key Results
Confirmed Objective Response Rate (Primary Endpoint)
By blinded IRC assessment, the confirmed objective response rate (cORR) was 45.9% in the 200 mg cohort, 47.2% in the 300 mg randomized cohort, and 45.8% in the 300 mg all-comers cohort. The predefined null hypothesis was rejected with statistical significance (P<.0001). (JCO 2025, JCO-25-00788) The FDA accelerated approval was based on 85 patients treated at the 200 mg once-daily dose, in whom the ORR was 46% (95% CI, 35%–57%). (FDA label, NDA 219839)
cORR ~46% — first oral option in post-platinum EGFR exon20ins NSCLCDuration of Response
Median duration of response was 11.1 months at 200 mg and 13.8 months at 300 mg, with durable responses observed across EGFR exon20ins subtypes. (JCO 2025)
DoR 11.1–13.8 monthsActivity in Hard-to-Treat Subgroups
Responses were observed in patients with baseline brain metastases (cORR 52.4% at 300 mg vs 28.6% at 200 mg) and in those previously treated with amivantamab (41.7% vs 25%) — subgroups with historically poor outcomes. (JCO 2025)
Safety & Tolerability
Adverse Event Profile
Sunvozertinib's safety profile was consistent with on-target EGFR inhibition. The most common treatment-related adverse events were diarrhea, skin rash, and blood creatine phosphokinase (CPK) increase; the majority were grade 1/2 and reversible. Grade ≥3 diarrhea and CPK elevation were more frequent at 300 mg than at 200 mg — data that informed the approved 200 mg once-daily starting dose. (JCO 2025 / FDA label)
FDA & Commercialization
KOL Sentiment on WU-KONG1B
Media Coverage
Frequently Asked Questions
What is the WU-KONG1B trial?
WU-KONG1B (WU-KONG1 Part B; NCT03974022) is a Phase 2 multinational pivotal study of oral sunvozertinib (Zegfrovy) in patients with advanced EGFR exon 20 insertion NSCLC whose disease progressed after platinum-based chemotherapy. Its confirmed objective response rate supported sunvozertinib's FDA accelerated approval.
Is sunvozertinib (Zegfrovy) FDA approved?
Yes. On July 2, 2025 the FDA granted sunvozertinib (Zegfrovy) accelerated approval for adults with locally advanced or metastatic EGFR exon 20 insertion–positive NSCLC whose disease progressed on or after platinum-based chemotherapy. It is the first oral targeted therapy approved for this mutation.
What were the WU-KONG1B response rates?
By blinded independent review, the confirmed objective response rate was ~46% (45.9% at 200 mg, 47.2% at 300 mg randomized, 45.8% at 300 mg all-comers; P<.0001). Median duration of response was 11.1 months at 200 mg and 13.8 months at 300 mg.
How does WU-KONG1B relate to WU-KONG28?
WU-KONG1B is the Phase 2 pivotal study supporting sunvozertinib's accelerated approval in the previously-treated (second-line and later) setting. WU-KONG28 is the confirmatory Phase 3 trial in the first-line setting, which met its primary endpoint (PFS) versus chemotherapy and was published in NEJM in 2026.
What is the AstraZeneca–Dizal deal for Zegfrovy?
On July 14, 2026, AstraZeneca entered an exclusive global license agreement with Dizal for Zegfrovy (sunvozertinib), acquiring worldwide rights to develop and commercialize the drug for $600 million upfront plus up to $900 million in milestones and tiered royalties. The deal is expected to close in the second half of 2026.
About This Profile
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Every clinical figure is traceable to a primary source (peer-reviewed publication, FDA label, or sponsor press release) as cited above. Last updated July 14, 2026.