- Pembrolizumab is safe and effective in patients with advanced NSCLC and performance status (PS) 2 as first- or subsequent-line therapy, offering outcomes similar to those in prior studies of patients with PS 0-1.
Why this matters
- Clinical trials of pembrolizumab included only NSCLC patients with PS 0-1, even though about 18% of all NSCLC patients have PS2.
- Currently, standard therapy for these patients in the United Kingdom is carboplatin-based chemotherapy as a first-line treatment and docetaxel as second-or-later line therapy.
- Multicenter phase 2 trial.
- 60 patients with advanced NSCLC and PS2 received pembrolizumab.
- Funding: MSD.
- Median follow-up, 10 months.
- 40% received pembrolizumab as first-line therapy.
- Median PFS, 4.4 months; median OS, 9.8 months.
- 37% reported a durable clinical benefit (DCB; 38% as first-line; 36% as second or greater).
- DCB higher in patients with greater tumor progression score (22% in TPS
- Objective response rate was 27% overall (31% in previously treated patients and 21% in treatment-naïve patients).
- 28% reported toxicity associated with dose delay or drug discontinuation.
- No grade 5 adverse events.
- Single-arm, open-label study.