David R Spigel MD; ASCO 2026: EGFR Exon-20 Insertion Directed Initial Therapy Cuts Disease Progression in Patients with Advanced Non-Small Cell Lung Cancer
CHICAGO, USA—For patients with advanced non-small cell lung cancer harboring the rare exon-20 gene insertion,first-line treatment with the targeted drug sunvozertinib monotherapy brought statistically significant anti-tumor efficacy when compared with chemotherapy in the phase three WU-KONG28 study reported to the 2026 Annual Meeting of the American Society of Clinical Oncology by John V Heymach MD PhD, Professor and Chair of Thoracic and Head and Neck Medical Oncology, at the University of Texas MD Anderson Cancer Center, in Houston. After hearing Dr. Heymach’s talk, Audio Journal of Oncology reporter Peter Goodwin caught up with ASCO commentator David R Spigel MD, President and Chief Medical Officer at the Sarah Cannon Research Institute in Nashville, Tennessee. (An interview with David R Spigel MD, President & Chief Medical Officer, Sarah Cannon Research Institute, Nashville, Tennessee, US)
EGFR Exon-20 Insertion Directed Initial Therapy Cuts Disease Progression in Patients with Advanced Non-Small Cell Lung Cancer
An interview with David R Spigel MD, President & Chief Medical Officer, Sarah Cannon Research Institute, Nashville, Tennessee, US
CHICAGO, USA—For patients with advanced non-small cell lung cancer harboring the rare exon-20 gene insertion,first-line treatment with the targeted drug sunvozertinib monotherapy brought statistically significant anti-tumor efficacy when compared with chemotherapy in the phase three WU-KONG28 study reported to the 2026 Annual Meeting of the American Society of Clinical Oncology by John V Heymach MD PhD, Professor and Chair of Thoracic and Head and Neck Medical Oncology, at the University of Texas MD Anderson Cancer Center, in Houston.
After hearing Dr. Heymach’s talk, Audio Journal of Oncology reporter Peter Goodwin caught up with ASCO commentator David R Spigel MD, President and Chief Medical Officer at the Sarah Cannon Research Institute in Nashville, Tennessee.
Audio Journal of Oncology; David R Spigel MD
IN: ”Peter Goodwin here at ….
OUT:…….for the Audio Journal of Oncology. 3: 53secs
Source: ASCO 2026:
https://ascopubs.org/doi/10.1200/JCO.2026.44.17_suppl.LBA8500
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).
Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Abstract
LBA8500
Background:
Sunvozertinib has been granted accelerated approval in the US and China for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor exon 20 insertion mutations (EGFR exon20ins) who failed platinum-based chemotherapy, based on results from two phase 2 single arm pivotal studies (WU-KONG1B [NCT03974022] and WU-KONG6 [NCT05712902]). WU-KONG28 (NCT05668988) is a multinational randomized confirmatory phase 3 study to compare sunvozertinib versus platinum-based chemotherapy as first-line treatment in advanced NSCLC patients with EGFR exon20ins. Here we reported the primary analysis of WU-KONG28 study results.
Methods:
Eligible patients were randomized in a 1:1 ratio, stratified by baseline brain metastasis status, to receive either sunvozertinib 300 mg once daily or chemotherapy (carboplatin [AUC5] and pemetrexed [500 mg/m²]) once every 3 weeks for up to 6 cycles, followed by pemetrexed maintenance therapy until disease progression or other discontinuation criteria were met. Patients in the chemotherapy arm could cross over to receive sunvozertinib upon confirmed progressive disease by the blinded independent central review (BICR). The primary endpoint was progression free survival (PFS) assessed by BICR per RECIST 1.1. Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response (DoR), and safety profile. PFS and OS were analyzed using log-rank test and Cox proportional hazards model. The data cutoff date was Jan 16, 2026. Results: A total of 324 patients were randomized to receive sunvozertinib (N=163) or chemotherapy (N=161). Baseline characteristics were generally balanced between the two arms. PFS by BICR was significantly longer with sunvozertinib than chemotherapy (median: 10.3 vs 7.5 months; hazard ratio [HR]: 0.65, 95% confidence interval [CI]: 0.50, 0.85, p=0.0008). The PFS benefit was consistent in trends across subgroups. In the chemotherapy arm, 90.2% of patients with BICR-confirmed disease progression crossed over to receive sunvozertinib. The OS data were immature. Patients in the sunvozertinib arm showed higher confirmed ORR (58.9% vs 31.1%) and longer median DoR (11.2 vs 7.1 months). Safety profile of sunvozertinib was similar to what was previously reported. Drug-related treatment emergent adverse events (TEAEs) leading to treatment discontinuation occurred in 7.4% of patients. No drug-related TEAE leading to fatal outcome was reported.
Conclusion:
Sunvozertinib demonstrated significantly superior antitumor efficacy than chemotherapy with a manageable safety profile. These results support sunvozertinib as a first-line treatment for advanced NSCLC harboring EGFR exon20ins.
Clinical trial information: NCT05668988.
References
- https://ascopubs.org/doi/10.1200/JCO.2026.44.17_suppl.LBA8500
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