Background: Nivolumab, a fully human IgG4, PD-1 immune-checkpoint inhibitor antibody, has shown durable clinical activity in phase I and II trials in several tumor types. Recently, a phase III study (CheckMate -017) demonstrated that nivolumab improved overall survival than docetaxel in second-line of sq NSCLC. Here, we report the results of two phase II studies to evaluate the efficacy and safety of nivolumab in previously treated advanced sq (JapicCTI-No.132072) and non-sq (JapicCTI-No.132073) NSCLC pts. Methods: Both studies require pts aged ≥ 20 years with ECOG status of 0 or 1, stage IIIB/IV, or recurrent NSCLC and at least one prior chemotherapy including platinum containing regimen.Pts received nivolumab 3 mg/kg IV Q2W until progression or unacceptable toxicity.The primary endpoint in both studies was the objective response rate (ORR) (RECIST v1.1).Planned sample size was 30 pts for Sq and 67 pts for Non-sq, respectively(P0=0.09, P1=0.26 , P0=0.09, P1=0.20 ; α=0.025 (one-side) , 1-β=0.8). Results: From April 2013 to April 2014, a total of 111 NSCLC pts were enrolled into two studies (35 pts with sq,76 pts with non-sq, male/female: 81/30; PS 0/1: 46/55; aged 31 to 84 [median: 65.0] years; Stage IIIB/Stage IV/recurrence: 6/86/19)Grade 3-4 drug related adverse events (G3AEs) were observed in 16.2 % (18/111) pts. Most common G3AEs were lymphocyte count decreased 3.6 % (4/111), hyponatremia 1.8 % (2/111), interstitial lung disease 1.8 % (2/111), pleural effusion 1.8 % (2/111). Any grade of Interstitial lung disease was observed in 4.5 % (5/111) pts. No grade 5 AEs were observed.Efficacy data were shown in table 1. Median follow-up was 10.4 months and 8.4 months, respectively. Conclusions: Nivolumab continues to demonstrate encouraging clinical efficacy in both sq and non-sq NSCLC with a manageable safety profile. Clinical trial information: 132072 and 132073.

DOR : duration of response