Efficacy and safety of nivolumab in routine NSCLC treatment – an observational study in 5 lung cancer centers in Berlin, Germany

Background: Immunotherapy with nivolumab has shown promising efficacy and safety in NSCLC patients. It was approved for treatment after failure of 1st line chemotherapy in 2015. Few data is available concerning the efficacy and safety of nivolumab in the real-life setting outside of clinical trials. Aims and objectives: To analyze the response rates and the frequency of immun-related adverse events (irAE) in NSCLC patients treated with nivolumab in the first year after approval in Europe. Methods: Relevant routine clinical data of all patients of 5 lung cancer centers in Berlin receiving nivolumab for treatment of NSCLC between 08/2015 and 08/2016 were prospectively recorded and retrospectively analyzed. Results: Overall, 148 patients (m: 100 pts. [67.6%], f: 48 pts. [32.4%], median age: 64 yrs.) were analyzed. 62 [41.9%] had adenocarcinoma, 83 [56.1%] squamous cell carcinoma and 3 [2.0%] other histology. Nivolumab was given in 1st (n=2; 1.4%), 2nd (n=82; 55.4%), 3rd (n=38; 25.7%) or later lines (n=26, 17.6%). Best response according to RECIST 1.1 was: CR 0%; PR 18.8%; SD 36.7%; PD 44.5%. ORR was 18.8% and DCR 55.5%. Most common irAE were: Dermatitis (max. CTC III°), endocrinological disorders (max. CTC II°), pneumonitis (max. CTC V°), colitis (max. CTC III°) and hepatitis (max. CTC IV°). There were 4 probable therapy-related deaths (2.7%). Conclusion: The use of nivolumab in routine NSCLC treatment shows promising efficacy consistent to the results of randomised clicinal trials. Despite a similar spectrum of irAE, therapy-related deaths occurred in our cohort. Thus, good selection and close monitoring is just as essential in routine care patients.