- Nivolumab continues to yield clinically meaningful OS, PFS, and duration of response (DOR) rates compared with docetaxel at 5 years in patients with previously treated advanced NSCLC.
Why this matters
- This is the longest follow-up to date for randomized phase 3 trials of programmed-death 1 (PD-1) inhibitors in previously treated advanced NSCLC.
- International, randomized, phase 3 CheckMate 017 and CheckMate 057 trials (minimum follow-up of 64.2 months and 64.5 months, respectively).
- 854 patients with advanced previously treated NSCLC received nivolumab (n=427) or docetaxel (n=427).
- Funding: Bristol Myers Squibb.
- 5-year pooled OS was significantly better with nivolumab compared with docetaxel:
- 13.4% vs 2.6%.
- HR: 0.68 (95% CI, 0.59-0.78).
- OS improvement with nivolumab persisted regardless of squamous or nonsquamous histology or tumor PD-1 expression.
- 5-year pooled PFS was better with nivolumab:
- 8.0% vs 0% docetaxel.
- HR: 0.79 (95% CI, 0.68-0.92).
- Nivolumab offered a better pooled objective response rate (19.7% vs 11.2%) and median DOR (19.9 months vs 5.6 months).
- No new safety signals for nivolumab at 5 years.
- Open-label trial.