Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.

Détails

ID Serval
serval:BIB_9D16DE496DBE
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.
Périodique
The New England journal of medicine
Auteur⸱e⸱s
Hellmann M.D., Paz-Ares L., Bernabe Caro R., Zurawski B., Kim S.W., Carcereny Costa E., Park K., Alexandru A., Lupinacci L., de la Mora Jimenez E., Sakai H., Albert I., Vergnenegre A., Peters S., Syrigos K., Barlesi F., Reck M., Borghaei H., Brahmer J.R., O'Byrne K.J., Geese W.J., Bhagavatheeswaran P., Rabindran S.K., Kasinathan R.S., Nathan F.E., Ramalingam S.S.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Statut éditorial
Publié
Date de publication
21/11/2019
Peer-reviewed
Oui
Volume
381
Numéro
21
Pages
2020-2031
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
In an early-phase study involving patients with advanced non-small-cell lung cancer (NSCLC), the response rate was better with nivolumab plus ipilimumab than with nivolumab monotherapy, particularly among patients with tumors that expressed programmed death ligand 1 (PD-L1). Data are needed to assess the long-term benefit of nivolumab plus ipilimumab in patients with NSCLC.
In this open-label, phase 3 trial, we randomly assigned patients with stage IV or recurrent NSCLC and a PD-L1 expression level of 1% or more in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. The patients who had a PD-L1 expression level of less than 1% were randomly assigned in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy alone. All the patients had received no previous chemotherapy. The primary end point reported here was overall survival with nivolumab plus ipilimumab as compared with chemotherapy in patients with a PD-L1 expression level of 1% or more.
Among the patients with a PD-L1 expression level of 1% or more, the median duration of overall survival was 17.1 months (95% confidence interval [CI], 15.0 to 20.1) with nivolumab plus ipilimumab and 14.9 months (95% CI, 12.7 to 16.7) with chemotherapy (P = 0.007), with 2-year overall survival rates of 40.0% and 32.8%, respectively. The median duration of response was 23.2 months with nivolumab plus ipilimumab and 6.2 months with chemotherapy. The overall survival benefit was also observed in patients with a PD-L1 expression level of less than 1%, with a median duration of 17.2 months (95% CI, 12.8 to 22.0) with nivolumab plus ipilimumab and 12.2 months (95% CI, 9.2 to 14.3) with chemotherapy. Among all the patients in the trial, the median duration of overall survival was 17.1 months (95% CI, 15.2 to 19.9) with nivolumab plus ipilimumab and 13.9 months (95% CI, 12.2 to 15.1) with chemotherapy. The percentage of patients with grade 3 or 4 treatment-related adverse events in the overall population was 32.8% with nivolumab plus ipilimumab and 36.0% with chemotherapy.
First-line treatment with nivolumab plus ipilimumab resulted in a longer duration of overall survival than did chemotherapy in patients with NSCLC, independent of the PD-L1 expression level. No new safety concerns emerged with longer follow-up. (Funded by Bristol-Myers Squibb and Ono Pharmaceutical; CheckMate 227 ClinicalTrials.gov number, NCT02477826.).
Mots-clé
Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological/administration & dosage, Antineoplastic Agents, Immunological/adverse effects, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, B7-H1 Antigen/metabolism, Carcinoma, Non-Small-Cell Lung/drug therapy, Carcinoma, Non-Small-Cell Lung/metabolism, Carcinoma, Non-Small-Cell Lung/mortality, Female, Humans, Ipilimumab/administration & dosage, Ipilimumab/adverse effects, Lung Neoplasms/drug therapy, Lung Neoplasms/metabolism, Lung Neoplasms/mortality, Male, Middle Aged, Nivolumab/administration & dosage, Nivolumab/adverse effects, Survival Analysis
Pubmed
Web of science
Création de la notice
02/10/2019 17:16
Dernière modification de la notice
21/11/2020 7:26
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