Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.
By M. Hellmann, L. Paz-Ares, R. Bernabé Caro, B. Żurawski, Sang-We Kim, E. Carcereny Costa, Keunchil Park, A. Alexandru, L. Lupinacci, Emmanuel de la Mora Jimenez and 16 more. New England Journal of Medicine, 2019
2,232 citations recorded by the source corpus.
BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.).
Subfields: Immunology, Oncology, Pulmonary and Respiratory Medicine
View Paper: https://www.semanticscholar.org/paper/9b5728997a4772ceb5d2d276d15751494ab49532
How researchers see this paper
The researchers whose trusted networks rank it highest, strongest advocate first. Every researcher gets a different order.
In Oncology
Citations in the corpus
- Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma. (2022, neutral): “Constipation 59 (19) 2 (1) 7 (2) 1 (<1) 66 (22) 1 (<1)”
- Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: A report from the ESMO Precision Medicine Working Group. (2020, background): “Several randomised, phase III trials have shown that EGFR tyrosine kinase inhibitors (TKIs) improve outcome in patients with EGFR-mutated NSCLC.27e30 Based on these data, these specific EGFR mutations reach the highest level in ESCAT.”
- Single-cell analysis reveals fibroblast clusters linked to immunotherapy resistance in cancer. (2020, result): “We also detected these distinct CAF-S1 cellular clusters in HNSCC and NSCLC, demonstrating the relevance of our findings across cancer types.”