Amivantamab plus Chemotherapy in NSCLC with
Humans
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Disease Progression
ErbB Receptors
/ genetics
Exons
/ genetics
Lung Neoplasms
/ drug therapy
Mutation
Protein Kinase Inhibitors
/ therapeutic use
Carboplatin
/ administration & dosage
Pemetrexed
/ administration & dosage
Antineoplastic Agents, Immunological
/ administration & dosage
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
30 Nov 2023
30 Nov 2023
Historique:
medline:
5
12
2023
pubmed:
23
10
2023
entrez:
23
10
2023
Statut:
ppublish
Résumé
Amivantamab has been approved for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor ( In this phase 3, international, randomized trial, we assigned in a 1:1 ratio patients with advanced NSCLC with A total of 308 patients underwent randomization (153 to receive amivantamab-chemotherapy and 155 to receive chemotherapy alone). Progression-free survival was significantly longer in the amivantamab-chemotherapy group than in the chemotherapy group (median, 11.4 months and 6.7 months, respectively; hazard ratio for disease progression or death, 0.40; 95% confidence interval [CI], 0.30 to 0.53; P<0.001). At 18 months, progression-free survival was reported in 31% of the patients in the amivantamab-chemotherapy group and in 3% in the chemotherapy group; a complete or partial response at data cutoff was reported in 73% and 47%, respectively (rate ratio, 1.50; 95% CI, 1.32 to 1.68; P<0.001). In the interim overall survival analysis (33% maturity), the hazard ratio for death for amivantamab-chemotherapy as compared with chemotherapy was 0.67 (95% CI, 0.42 to 1.09; P = 0.11). The predominant adverse events associated with amivantamab-chemotherapy were reversible hematologic and EGFR-related toxic effects; 7% of patients discontinued amivantamab owing to adverse reactions. The use of amivantamab-chemotherapy resulted in superior efficacy as compared with chemotherapy alone as first-line treatment of patients with advanced NSCLC with
Sections du résumé
BACKGROUND
BACKGROUND
Amivantamab has been approved for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (
METHODS
METHODS
In this phase 3, international, randomized trial, we assigned in a 1:1 ratio patients with advanced NSCLC with
RESULTS
RESULTS
A total of 308 patients underwent randomization (153 to receive amivantamab-chemotherapy and 155 to receive chemotherapy alone). Progression-free survival was significantly longer in the amivantamab-chemotherapy group than in the chemotherapy group (median, 11.4 months and 6.7 months, respectively; hazard ratio for disease progression or death, 0.40; 95% confidence interval [CI], 0.30 to 0.53; P<0.001). At 18 months, progression-free survival was reported in 31% of the patients in the amivantamab-chemotherapy group and in 3% in the chemotherapy group; a complete or partial response at data cutoff was reported in 73% and 47%, respectively (rate ratio, 1.50; 95% CI, 1.32 to 1.68; P<0.001). In the interim overall survival analysis (33% maturity), the hazard ratio for death for amivantamab-chemotherapy as compared with chemotherapy was 0.67 (95% CI, 0.42 to 1.09; P = 0.11). The predominant adverse events associated with amivantamab-chemotherapy were reversible hematologic and EGFR-related toxic effects; 7% of patients discontinued amivantamab owing to adverse reactions.
CONCLUSIONS
CONCLUSIONS
The use of amivantamab-chemotherapy resulted in superior efficacy as compared with chemotherapy alone as first-line treatment of patients with advanced NSCLC with
Identifiants
pubmed: 37870976
doi: 10.1056/NEJMoa2306441
doi:
Substances chimiques
amivantamab-vmjw
0
EGFR protein, human
EC 2.7.10.1
ErbB Receptors
EC 2.7.10.1
Protein Kinase Inhibitors
0
Carboplatin
BG3F62OND5
Pemetrexed
04Q9AIZ7NO
Antineoplastic Agents, Immunological
0
Banques de données
ClinicalTrials.gov
['NCT04538664']
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
2039-2051Investigateurs
Andres Aguilar
(A)
Jorge Arturo Alatorre
(JA)
Adlinda Alip
(A)
Andrea Ardizzoni
(A)
Oscar Gerardo Arrieta
(OG)
Isabel Azevedo
(I)
Koichi Azuma
(K)
Clarissa Baldotto
(C)
Ana Barroso
(A)
Ullas Batra
(U)
Reyes Bernabe Caro
(R)
Ahmet Bilici
(A)
Bivas Biswas
(B)
Samantha Bowyer
(S)
Michael Boyer
(M)
Farastuk Bozorgmehr
(F)
Emilio Bria
(E)
Enric Carcereny Costa
(E)
Gee-Chen Chang
(GC)
Yuan Chen
(Y)
Jianhua Chen
(J)
Susanna Cheng
(S)
Byoung Chul Cho
(BC)
Irfan Cicin
(I)
Timucin Cil
(T)
Alexis Cortot
(A)
Sulene Cunha Souza Oliveira
(SCS)
Pongwut Danchaivijitr
(P)
Javier De Castro
(J)
Gilberto De Castro Junior
(G)
Angelo Delmonte
(A)
Christophe Dooms
(C)
Michaël Duruisseaux
(M)
Rafal Dziadziuszko
(R)
Yong Fang
(Y)
Enriqueta Felip
(E)
Miguel Fernández Sanmamed
(M)
Daichi Fujimoto
(D)
Maria Del Rosario Garcia Campelo
(M)
Pilar Garrido
(P)
Ana Caroline Gelatti
(AC)
Nicolas Girard
(N)
Jonathan Goldman
(J)
Jerome Goldschmidt
(J)
Frank Griesinger
(F)
Mahmut Gumus
(M)
Zhongliang Guo
(Z)
Xiaosheng Hang
(X)
Osamu Hataji
(O)
Hidetoshi Hayashi
(H)
Yi Hu
(Y)
Jen-Yu Hung
(JY)
Dolores Isla
(D)
Minish Jain
(M)
Tetsuji Kawamura
(T)
Stephan Disean Kendall
(SD)
Chul Kim
(C)
Yu Jung Kim
(YJ)
Sang-We Kim
(SW)
Nikolay Kislov
(N)
Satoru Kitazono
(S)
Dariusz Kowalski
(D)
Kang-Yun Lee
(KY)
Se-Hoon Lee
(SH)
Young Joo Lee
(YJ)
Yun-Gyoo Lee
(YG)
Wen Li
(W)
Chun Sen Lim
(CS)
Zhe Liu
(Z)
Caigang Liu
(C)
Baogang Liu
(B)
Shun Lu
(S)
Dongqing Lv
(D)
M V T Krishna Mohan
(MVTK)
Margarita Majem
(M)
Shingo Matsumoto
(S)
Ofer Merimsky
(O)
Josiane Mourao Dias
(J)
Rajnish Nagarkar
(R)
Misako Nagasaka
(M)
Hiromi Nagashima
(H)
Hovav Nechushtan
(H)
Vanita Noronha
(V)
Sebahat Ocak
(S)
Francesca Ogliari
(F)
Masahide Oki
(M)
Akira Ono
(A)
Gyula Ostoros
(G)
Scott Owen
(S)
Ozgur Ozyilkan
(O)
Luiz Paz-Ares Rodriguez
(L)
Nir Peled
(N)
Dmitry Ponomarenko
(D)
Sanjay Popat
(S)
Steven Powell
(S)
Naiyarat Prasongsook
(N)
Claudia Proto
(C)
Immaculada Ramos Garcia
(I)
Gary Richardson
(G)
Joshua Sabari
(J)
Victor Santos
(V)
Yuki Sato
(Y)
Mehmet Ali Nahit Sendur
(MAN)
Hong Shen
(H)
Catherine Shu
(C)
Felipe José Silva Melo Cruz
(FJ)
Hwoei Fen Soo Hoo
(HFS)
Hector Jose Soto Parra
(HJ)
Alexander Spira
(A)
David Stewart
(D)
Daniil Stroyakovskiy
(D)
Ping Sun
(P)
Hiroshi Tanaka
(H)
Ke-Jing Tang
(KJ)
Encarnacao Teixeira
(E)
Muthukkumaran Thiagarajan
(M)
Rémi Veillon
(R)
Huijie Wang
(H)
Donglin Wang
(D)
Naohiro Watanabe
(N)
Lin Wu
(L)
Yong Xu
(Y)
Yu Yao
(Y)
Ozan Yazici
(O)
Toshihide Yokoyama
(T)
Hiroshige Yoshioka
(H)
Yanqiu Zhao
(Y)
Jun Zhao
(J)
Caicun Zhou
(C)
Jianying Zhou
(J)
Bogdan Zurawski
(B)
Informations de copyright
Copyright © 2023 Massachusetts Medical Society.