Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC.
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ adverse effects
Antineoplastic Agents
/ adverse effects
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
B7-H1 Antigen
/ metabolism
Carboplatin
/ administration & dosage
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Carcinoma, Squamous Cell
/ drug therapy
Cisplatin
/ administration & dosage
Deoxycytidine
/ administration & dosage
Female
Humans
Lung Neoplasms
/ drug therapy
Male
Middle Aged
Mutation
Survival Analysis
Gemcitabine
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:
01 10 2020
01 10 2020
Historique:
entrez:
30
9
2020
pubmed:
1
10
2020
medline:
21
10
2020
Statut:
ppublish
Résumé
The efficacy and safety of the anti-programmed death ligand 1 (PD-L1) monoclonal antibody atezolizumab, as compared with those of platinum-based chemotherapy, as first-line treatment for patients with metastatic non-small-cell lung cancer (NSCLC) with PD-L1 expression are not known. We conducted a randomized, open-label, phase 3 trial involving patients with metastatic nonsquamous or squamous NSCLC who had not previously received chemotherapy and who had PD-L1 expression on at least 1% of tumor cells or at least 1% of tumor-infiltrating immune cells as assessed by the SP142 immunohistochemical assay. Patients were assigned in a 1:1 ratio to receive atezolizumab or chemotherapy. Overall survival (primary end point) was tested hierarchically according to PD-L1 expression status among patients in the intention-to-treat population whose tumors were wild-type with respect to Overall, 572 patients were enrolled. In the subgroup of patients with Atezolizumab treatment resulted in significantly longer overall survival than platinum-based chemotherapy among patients with NSCLC with high PD-L1 expression, regardless of histologic type. (Funded by F. Hoffmann-La Roche/Genentech; IMpower110 ClinicalTrials.gov number, NCT02409342.).
Sections du résumé
BACKGROUND
The efficacy and safety of the anti-programmed death ligand 1 (PD-L1) monoclonal antibody atezolizumab, as compared with those of platinum-based chemotherapy, as first-line treatment for patients with metastatic non-small-cell lung cancer (NSCLC) with PD-L1 expression are not known.
METHODS
We conducted a randomized, open-label, phase 3 trial involving patients with metastatic nonsquamous or squamous NSCLC who had not previously received chemotherapy and who had PD-L1 expression on at least 1% of tumor cells or at least 1% of tumor-infiltrating immune cells as assessed by the SP142 immunohistochemical assay. Patients were assigned in a 1:1 ratio to receive atezolizumab or chemotherapy. Overall survival (primary end point) was tested hierarchically according to PD-L1 expression status among patients in the intention-to-treat population whose tumors were wild-type with respect to
RESULTS
Overall, 572 patients were enrolled. In the subgroup of patients with
CONCLUSIONS
Atezolizumab treatment resulted in significantly longer overall survival than platinum-based chemotherapy among patients with NSCLC with high PD-L1 expression, regardless of histologic type. (Funded by F. Hoffmann-La Roche/Genentech; IMpower110 ClinicalTrials.gov number, NCT02409342.).
Identifiants
pubmed: 32997907
doi: 10.1056/NEJMoa1917346
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Antineoplastic Agents
0
B7-H1 Antigen
0
CD274 protein, human
0
Deoxycytidine
0W860991D6
atezolizumab
52CMI0WC3Y
Carboplatin
BG3F62OND5
Cisplatin
Q20Q21Q62J
Gemcitabine
0
Banques de données
ClinicalTrials.gov
['NCT02409342']
Types de publication
Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1328-1339Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2020 Massachusetts Medical Society.