First-Line Sunvozertinib in NSCLC with <i>EGFR</i> Exon 20 Insertion Mutations

BACKGROUND: ) exon 20 insertion mutations. Data are needed on the efficacy and safety of sunvozertinib as a first-line treatment for NSCLC. METHODS: exon 20 insertions to receive sunvozertinib or chemotherapy (carboplatin-pemetrexed). The primary end point was progression-free survival as assessed by blinded independent central review. Crossover to the sunvozertinib group was allowed after disease progression was confirmed. Secondary end points included overall survival, investigator-assessed progression-free survival, objective response (complete or partial response), change in tumor size, and duration of response. RESULTS: A total of 324 patients were randomly assigned to receive sunvozertinib (163 patients) or chemotherapy (161 patients). Treatment with sunvozertinib led to significantly longer median progression-free survival than chemotherapy (10.3 vs. 7.5 months; hazard ratio for disease progression or death, 0.65; 95% confidence interval, 0.50 to 0.85; P<0.001). At 12 months, progression-free survival was reported in 46.1% of the patients in the sunvozertinib group and in 26.7% of those in the chemotherapy group; the data for overall survival were immature (38.9% maturity). The percentage of patients with an objective response was 58.9% in the sunvozertinib group and 31.1% in the chemotherapy group; the median best percentage change in tumor size was -42.1% and -24.7% respectively, and the median duration of response was 11.2 and 7.1 months. Grade 3 or higher adverse events were reported in 75.5% of the patients in the sunvozertinib group and in 56.7% of those in the chemotherapy group. In the sunvozertinib group, the most common adverse events of grade 3 or higher included increased serum creatine kinase levels, diarrhea, and anemia. No deaths were attributed to adverse events considered by the investigators to be related to sunvozertinib. CONCLUSIONS: exon 20 insertions. (Funded by Dizal Pharmaceuticals; WU-KONG28 ClinicalTrials.gov number, NCT05668988.).

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Journal
New England Journal of Medicine
Published
2026-05-29
DOI
https://doi.org/10.1056/nejmoa2604461
Primary Topic
Lung Cancer Treatments and Mutations
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article
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article

First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations

洪群英, Elaine Shum, L Antonuzzo, Denis Moro-Sibilot et al.
New England Journal of Medicine
Lung Cancer Treatments and Mutations
article

First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations

洪群英, Elaine Shum, L Antonuzzo, Denis Moro-Sibilot, J Heymach, Laurent Greillier, Elvire Pons-Tostivint, Ludovic Doucet, Mengzhao Wang, Regan M. Memmott, Dariusz Kowalski, Ozan Yazici, Dingzhi Huang, Meili Sun, Gonzalo Fernandez-Hinojal, Federica Bertolini, Li Zheng, Thomas John, Chengzhi Zhou, Yun Fan, Geoffrey Liu, Caicun Zhou, Jian Fang, Yan Yu, D. Ross Camidge, Ligang Xing, Jaafar Bennouna, Catherine Shu, Gilberto de Castro, Bo Jin
article en

Abstract

BACKGROUND: ) exon 20 insertion mutations. Data are needed on the efficacy and safety of sunvozertinib as a first-line treatment for NSCLC. METHODS: exon 20 insertions to receive sunvozertinib or chemotherapy (carboplatin-pemetrexed). The primary end point was progression-free survival as assessed by blinded independent central review. Crossover to the sunvozertinib group was allowed after disease progression was confirmed. Secondary end points included overall survival, investigator-assessed progression-free survival, objective response (complete or partial response), change in tumor size, and duration of response. RESULTS: A total of 324 patients were randomly assigned to receive sunvozertinib (163 patients) or chemotherapy (161 patients). Treatment with sunvozertinib led to significantly longer median progression-free survival than chemotherapy (10.3 vs. 7.5 months; hazard ratio for disease progression or death, 0.65; 95% confidence interval, 0.50 to 0.85; P<0.001). At 12 months, progression-free survival was reported in 46.1% of the patients in the sunvozertinib group and in 26.7% of those in the chemotherapy group; the data for overall survival were immature (38.9% maturity). The percentage of patients with an objective response was 58.9% in the sunvozertinib group and 31.1% in the chemotherapy group; the median best percentage change in tumor size was -42.1% and -24.7% respectively, and the median duration of response was 11.2 and 7.1 months. Grade 3 or higher adverse events were reported in 75.5% of the patients in the sunvozertinib group and in 56.7% of those in the chemotherapy group. In the sunvozertinib group, the most common adverse events of grade 3 or higher included increased serum creatine kinase levels, diarrhea, and anemia. No deaths were attributed to adverse events considered by the investigators to be related to sunvozertinib. CONCLUSIONS: exon 20 insertions. (Funded by Dizal Pharmaceuticals; WU-KONG28 ClinicalTrials.gov number, NCT05668988.).

New England Journal of Medicine
University of Modena and Reggio Emilia (IT), University Health Network (CA), The University of Texas MD Anderson Cancer Center (US), Harbin Medical University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Peking University (CN), Fudan University (CN), Columbia University Irving Medical Center (US), Centre Hospitalier Universitaire de Grenoble (FR), Peter MacCallum Cancer Centre (AU), Peking Union Medical College Hospital (CN), Tianjin Medical University Cancer Institute and Hospital (CN), Princess Margaret Cancer Centre (CA), Centre Hospitalier Universitaire de Nantes (FR), NYU Langone Health (US), Assistance Publique Hôpitaux de Marseille (FR), Instituto do Câncer do Estado de São Paulo (BR), Azienda Unita' Sanitaria Locale Di Modena (IT), Peking University Cancer Hospital (CN), First Affiliated Hospital of Guangzhou Medical University (CN), Zhejiang Cancer Hospital (CN), Shandong Tumor Hospital (CN), Third Affiliated Hospital of Harbin Medical University (CN), Institut de Cancérologie de l'Ouest (FR), Jinan Central Hospital (CN), Ohio State University Hospital (US), Hôpital Nord (FR), Azienda Ospedaliero-Universitaria Careggi (IT), Zhongshan Hospital (CN), Shanghai East Hospital (CN), University of Colorado Cancer Center (US), Clinica Universidad de Navarra (ES), First Hospital of China Medical University (CN), Hôpital Foch (FR), Hôpital Albert Michallon (FR), Shandong First Medical University (CN), Shanghai Institute of Pharmaceutical Industry (CN), Narodowy Instytut Leków (PL), China Medical University (CN), Guangzhou Medical University (CN), University of Colorado Denver (US), Gazi University (TR)
Openalex Percentile: Top 6%
Lung Cancer Treatments and Mutations
DOISourceOpenAlex
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