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Background: The PD-1Is pembrolizumab P and nivolumab N have demonstrated clinical activity in multiple tumor types. They can lead to unique immune related adverse events irAEs . Studies have shon conflicting results on hether the development of irAEs correlates ith clinical response in melanoma patients pts . Correlation of irAEs ith better response in other cancer subtypes is unknon. Methods: We conducted a retrospective study of non-melanoma pts ho received PD-1Is at our institution. The primary objectives ere to correlate the development of any irAE, or any irAE requiring steroid use, ith clinical response. Incidence of irAEs and steroid use as assessed via revie of all relevant patient charts. Response as recorded at first restaging scan, and endpoints included overall response rate ORR per RECIST, overall survival OS , and time to next therapy or death TTNTD . Fishers exact tests ere used to determine the association beteen irAE incidence and ORR and Kaplan-Meier curves ith log-rank tests for the comparison of OS and TTNTD. Results: From November 2011-December 2015, 135 patients ere treated ith N or P; average age as 64 years, 88 65 percent ere male. The majority received N 101, 75 percent . Cancer sub-type as as follos: non-small cell lung cancer 59, 44 percent , renal cell carcinoma 31, 23 percent , head and neck cancer 24, 18 percent , urothelial carcinoma 18, 13 percent , other 3, 2 percent . Overall, irAEs ere noted in 60 45.9 percent ith steroids required in 41 30.4 percent . Endocrinopathies, dermatitis and colitis occurred in 25.9 percent, 7.4 percent and 6.7 percent of patients, respectively. Of the 112 pts for hom complete response data as available, e found no significant correlation beteen ORR and either incidence of any irAE p = 0.21 or the use of steroids p = 0.27 . There as also no significant association of irAE incidence or steroid use ith OS p = 0.981, p = 0.954 respectively or TTNTD p = 0.277, p = 0.377 respectively . Conclusions: This retrospective revie shoed no association beteen the development of irAEs and outcomes in non-melanoma pts treated ith PD-1Is. This data may be limited by sample size and disease heterogeneity, or may reflect differences in biology as compared to patients ith melanoma.,J Clin Oncol 34, 2016 suppl; abstr 3069 00:00.0,Developmental TherapeuticsImmunotherapy