TY  - BOOK
AU  - Zhou, Caicun 
AU  - Greillier, Laurent 
AU  - Liu, Geoffrey 
AU  - John, Thomas 
AU  - Xing, Ligang 
AU  - Kowalski, Dariusz  
AU  - Memmott, Regan M. 
AU  - Yazici, Ozan  
AU  - Sun, Meili  
AU  - Shu, Catherine A. 
AU  - Pons-Tostivint, Elvire 
TI  - First-line sunvozertinib in NSCLC with EGFR exon 20 insertion mutations
KW  - CÁNCER DE PULMÓN
KW  - NEUMOLOGÍA
KW  - CUIDADOS INTENSIVOS GENERAL
KW  - TRATAMIENTOS EN ONCOLOGÍA
N2  - Background: Sunvozertinib received accelerated approval for use in later lines of therapy for patients with advanced non–small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Data are needed on the efficacy and safety of sunvozertinib as a first-line treatment for NSCLC. Methods: In this phase 3, international trial, we randomly assigned, in a 1:1 ratio, patients with advanced nonsquamous NSCLC with EGFR 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: The efficacy of sunvozertinib was superior to that of chemotherapy as first-line treatment for advanced NSCLC with EGFR exon 20 insertions
ER  -