Table 1.
Phase | Author | Line of treatment | Sample size | ORR (%) | PFS (months) (95% CI) | OS (months) (95% CI) | Limitations |
---|---|---|---|---|---|---|---|
I | Topalian NEJM2012 [Topalian et al. 2012], Gettinger JCO2015 [Gettinger et al. 2015] | Second line and beyond | 54 | 16.7 | NA | 9.2 (7.3–12.5) | Small sample size Multiple treatment lines |
I | Gettinger ASCO2015 [Gettinger et al. 2015] | First line | 13 | 15 | NA | 18.2 (CI not reported) | Small sample size First line only |
II (CHECKMATE 063) | Rizvi Lancet 2015 [Rizvi et al. 2015] | Third line and beyond | 117 | 14.5 | 1.9 (1.8–3.2) | 8.2 (6.1–10.9) | Heavily pretreated population, with 20.5% of patients having 4 or more lines of previous treatment |
II (ONO-4538-050) | Nakagawa JTO2015 [Nakagawa et al. 2015] | Second line and beyond | 35 | 25.7 | 4.2 (1.5–7.1) | Not reached (12.4–not reached) | Preliminary results Small sample size Asian population Multiple treatment lines |
II (CHECKMATE 153) | Hussein WLCC2015 [Hussein et al. 2015] | Second line or more | 145 | 13 | NA | NA | Preliminary results Study compared 1 year versus continuous nivolumab Multiple treatment lines |
III (CHECKMATE 017) | Brahmer NEJM2015 [Brahmer et al. 2015] | Second line | 272 | 20 | 3.5 (2.1–4.9) | 9.2 (7.3–13.3) | Retrospective analysis of PD-L1 expression Compared against docetaxel whereas newer regimens such as docetaxel + ramucirumab is superior to docetaxel |
CI, confidence interval; NA, not available; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; SCC, squamous cell carcinoma.