Overall Survival with Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Yang James Chih-Hsin, Lu Shun, Hayashi Hidetoshi, Felip Enriqueta, Spira Alexander I, Girard Nicolas, Kim Yu Jung, Lee Se-Hoon, Ostapenko Yurii, Danchaivijitr Pongwut, Liu Baogang, Alip Adlinda, Korbenfeld Ernesto, Mourão Dias Josiane, Besse Benjamin, Passaro Antonio, Lee Ki-Hyeong, Xiong Hailin, How Soon-Hin, Cheng Ying, Chang Gee-Chen, Yoshioka Hiroshige, Thomas Michael, Nguyen Danny, Ou Sai-Hong Ignatius, Mukhedkar Sanjay, Prabhash Kumar, D'Arcangelo Manolo, Alatorre-Alexander Jorge, Vázquez Limón Juan Carlos, Alves Sara, Stroyakovskiy Daniil, Peregudova Marina, Şendur Mehmet Ali Nahit, Yazici Ozan, Califano Raffaele, Gutiérrez Calderón Vanesa, de Marinis Filippo, Kim Sang-We, Gadgeel Shirish M, Owen Scott, Xie John, Sun Tao, Mehta Jaydeep, Venkatasubramanian Raja, Ennis Mariah, Fennema Elizabeth, Daksh Mahesh, Roshak Amy, Man Julie, Knoblauch Roland E, Bauml Joshua M, Baig Mahadi, Shah Sujay, Sethi Seema, Cho Byoung Chul, MARIPOSA Investigators
Аннотация
METHODS: We randomly assigned, in a 2:2:1 ratio, participants with previously untreated EGFR-mutated (exon 19 deletion or L858R substitution), locally advanced or metastatic NSCLC to receive amivantamab-lazertinib, osimertinib, or lazertinib. Overall survival (assessed in an analysis of the time from randomization to death from any cause) in the amivantamab-lazertinib group as compared with the osimertinib group was a key secondary end point. Additional end points included safety.
RESULTS: A total of 429 participants each were assigned to receive amivantamab-lazertinib or osimertinib. Over a median follow-up of 37.8 months, amivantamab-lazertinib led to significantly longer overall survival than osimertinib (hazard ratio for death, 0.75; 95% confidence interval, 0.61 to 0.92; P = 0.005); 3-year overall survival was 60% and 51%, respectively. At the clinical cutoff date, 38% of participants in the amivantamab-lazertinib group and 28% in the osimertinib group were still receiving the assigned treatment. Adverse events of grade 3 or higher were more common with amivantamab-lazertinib (in 80% of participants) than with osimertinib (in 52%), particularly skin-related events, venous thromboembolism, and infusion-related events; these findings were consistent with the established safety profile of each treatment. No new safety signals were observed with additional follow-up.
CONCLUSIONS: Amivantamab-lazertinib led to significantly longer overall survival among participants with previously untreated EGFR-mutated advanced NSCLC than osimertinib but was associated with an increased risk of adverse events of grade 3 or higher. (Funded by Janssen Research and Development; MARIPOSA ClinicalTrials.gov number, NCT04487080.).