First-line treatment with nivolumab was not superior to investigator’s choice of platinum-based doublet chemotherapy for progression-free survival among patients with stage IV/recurrent programmed death ligand 1 (PD-L1)–positive non-small cell lung cancer (NSCLC), according to a study presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1
Nivolumab has demonstrated promising activity with a manageable safety profile as monotherapy and in combination with ipilimumab in treatment-naive patients with advanced NSCLC. Researchers evaluated the efficacy of nivolumab versus platinum-based double chemotherapy as first-line therapy for stage IV/recurrent PD-L1 NSCLC.
For the open-label, phase 3 CheckMate 026 trial (ClinicalTrials.gov Identifier: NCT02041533), investigators enrolled 541 patients with previously untreated advanced NSCLC and randomly assigned them 1:1 to receive nivolumab every 2 weeks until disease progression or unacceptable toxicity, or investigator’s choice of platinum-based doublet chemotherapy every 3 weeks for up to 6 cycles. Of those, 423 had PD-L1 tumor expression of 5% or greater.
Among those with 5% or greater PD-L1 expression, there was no significant difference in progression-free survival between the 2 treatment arms (hazard ratio, 1.15; 95% CI, 0.91-1.45; P = .25). Median progression-free survival was 4.2 months and 5.9 months with nivolumab and chemotherapy, respectively.
Investigators also found that no significant difference in median overall survival between the 2 groups (hazard ratio, 1.02; 95% CI, 0.80-1.30).
Among all patients, the rates of any grade and grade 3 to 4 treatment-related adverse events were 71% and 18% with nivolumab, versus 92% and 51% with chemotherapy, respectively. No new safety signals were observed with nivolumab, and it appeared to be less toxic than with chemotherapy.
The findings suggest that further research is needed to better understand the utility of the PD-L1 biomarker for patient selection in this treatment setting.
- Socinski M, Creelan B, Horn L, et al. CheckMate 026: A phase 3 trial of nivolumab vs investigator’s choice (IC) of platinum-based doublet chemotherapy (PT-DC) as first-line therapy for stage IV/recurrent programmed death ligand 1 (PD-L1)–positive NSCLC. Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.