asco@alo33:164396 JSONTXT

Background: the PD-1 blocking mAb PEMBRO is approved for the treatment of patients pts ith advanced melanoma. The correlation beteen baseline clinical characteristics and outcome of pts treated outside of a prospective clinical trial has not been established. Methods: using Kaplan-Meier survival probability analysis, log-rank testing and multivariate Cox-regression analysis, correlations ere investigated beteen baseline clinical variables and survival PFS and OS in pts ith pretreated advanced melanoma ho received PEMBRO in an EAP. An independent pt-cohort served to confirm the correlations found in an exploratory cohort. Results: all pts in the exploratory EC; N = 98 and confirmatory CC; N = 91 cohort had advanced pretreated melanoma and received at least one administration of PEMBRO 2 mgkg, every 3 ks . Baseline characteristics of the EC + CC population N = 189 ere: median age 60y range 26-93 ; 56 percent F; primary site: 81 percent skin, 15 percent UKN, 4 percent mucosal; 49 percent BRAF V600mut; 82 percent AJCC stage IV-M1c; 33 percent brain metastases; 52 percent CRP ULN; 36 percent LDH ULN; 18 percent absolute lymphocyte count ALC lt 1000mmxB3;. For the total population median PFS as 13 ks 95 percent 9-17 , median OS as not reached. PFS and OS did not differ beteen EC and CC populations. Age, gender and primary site ere not correlated ith survival in either cohort. In both cohorts a significant correlation univariate analysis as found beteen PFSOS and PS, ALC lt 500mmxB3; and LDH ULN. EC-pts ith baseline stage IV-M1c, brain metastases, and CRP 5xULN had a significantly orse PFSOS but these correlations did not reach significance in the CC-pts. All pts ith a baseline ALC of lt 500mmxB3; N = 7 [4 percent] in the EC + CC ere found to have a PFSOS of 500mmxB3; N: 179 , mutivariate analysis identified PS, LDH 1.5xULN and CRP 5xULN as independent baseline co-variables for PFSOS. Conclusions: PFS and OS of pts ith pretreated advanced melanoma ho received PEMBRO in an EAP as comparable to that of similar populations treated in prospective clinical trials. Significant correlations ere found beteen baseline PS, ALC, LDH, CRP and survival.,J Clin Oncol 34, 2016 suppl; abstr e21058 ,Publication Only: