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. 2016 Jul 31;10(5):444–454. doi: 10.1177/1753465816661091

Table 1.

Trials of nivolumab in SCC lung.

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.