First-Line Nivolumab Plus Ipilimumab in Advanced Non–Small-Cell Lung Cancer (CheckMate 568): Outcomes by Programmed Death Ligand 1 and Tumor Mutational Burden as Biomarkers
Duke Medical Center · Memorial Sloan Kettering Cancer Center · +28 more institutions
Abstract
PURPOSE CheckMate 568 is an open-label phase II trial that evaluated the efficacy and safety of nivolumab plus low-dose ipilimumab as first-line treatment of advanced/metastatic non–small-cell lung cancer (NSCLC). We assessed the association of efficacy with programmed death ligand 1 (PD-L1) expression and tumor mutational burden (TMB). PATIENTS AND METHODS Two hundred eighty-eight patients with previously untreated, recurrent stage IIIB/IV NSCLC received nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks. The primary end point was objective response rate (ORR) in patients with 1% or more and less than 1% tumor PD-L1 expression. Efficacy on the basis of TMB (FoundationOne CDx assay) was a…
Citation impact
- FWCI
- 41.35
- Percentile
- 100%
- References
- 28
Authors
28Topics & keywords
- Nivolumab
- Medicine
- Ipilimumab
- Internal medicine
- Lung cancer
- Oncology
- Clinical endpoint
- Cancer
- Good health and well-being
Funding
- AAmgen
- BSBristol-Myers Squibb
- ELEli Lilly and Company
- PPfizer
- AAstraZeneca
- SSanofi
- GSGilead Sciences
- APAriad Pharmaceuticals
- CCelgene
- UOUniversity of Pennsylvania
- KTKaryopharm Therapeutics
- ABArray BioPharma
- RPRegeneron Pharmaceuticals
- NNovocure
- TTTG Therapeutics
- COClovis Oncology
- AAcceleron
- APAgios Pharmaceuticals
- JTJounce Therapeutics
- MTMirati Therapeutics
- IIncyte
- SPSyndax Pharmaceuticals
- MModerna
- EEisai
- OPOno Pharmaceutical
- GGenentech
- ESEMD Serono
- TOTakeda Oncology
- IIgnyta
- FMFoundation Medicine
- JPJanssen Pharmaceuticals
- DSDaiichi Sankyo Europe