- In patients with previously treated non-small cell lung cancer (NSCLC), 5-years overall survival (OS) rates increased more than 4-fold after treatment with the PD-1 inhibitor nivolumab compared to docetaxel.
- No new safety signals emerged for nivolumab in the long-term and the drug remained well-tolerated.
Why this matters
- Historically, survival outcomes for advanced NSCLC have been poor.
- 5-years outcomes from CheckMate 017 and 057 represent the longest survival follow-up for randomized phase 3 trials of an immune checkpoint inhibitor in this population.
- CheckMate 017 and CheckMate 057 randomized phase 3 trials included patients with, respectively, squamous and non-squamous previously treated advanced NSCLC.
- In the pooled analysis (CheckMate 017/057), 854 patients with ECOG performance status (PS) ≤ 1, progressing during or after first-line platinum-based chemotherapy were included.
- Patients were randomized to nivolumab 3 mg/kg q2w or docetaxel 75 mg/m2 q3w until progression or unacceptable toxicity.
- OS was the primary endpoint for the two studies; additional endpoints included progression-free survival (PFS), objective response rate (ORR), efficacy by tumour PD-L1 expression, safety, PROs.
- Survival benefits were still evident for nivolumab vs docetaxel in the long-term pooled analysis, with 5-year OS rates 13.4% vs 2.6% (HR 0.68).
- OS benefit with nivolumab vs docetaxel was observed across subgroups of patients.
- The 5-years pooled PFS rate was 8% with nivolumab and 0% with docetaxel.
- The chance of remaining progression-free at 5 years was 60% and 78% in patients without progression at 2 and 3 years, respectively, after treatment with nivolumab.
- ORR was 19.7% for nivolumab and 11.2% for docetaxel.
- At 5 years, 10% of survivors in nivolumab group were off study drug, progression-free and with no subsequent therapy vs 0% in the docetaxel group.
- No evidence of grade 3-4 treatment-related adverse events (AE) and no new safety signals emerged for nivolumab with a minimum follow-up of 5 years.
- Bristol-Myers Squibb.
“It is interesting to note that, following platinum-based chemotherapy, nivolumab has shown survival benefits across all PD-L1 subsets, including the PD-L1 negative (