1127P - Correlation between baseline characteristics and clinical outcome of patients with advanced melanoma treated with pembrolizumab (PEMBRO)

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Skin Cancers
Presenter Yanina Jansen
Citation Annals of Oncology (2016) 27 (6): 379-400. 10.1093/annonc/mdw379
Authors Y. Jansen1, E..A. Rozeman2, L. Højberg3, M. Geukes Foppen4, M. Schreuer5, J.V. van Thienen6, L. Bastholt7, H. Schmidt8, J.B.A.G. Haanen9, I.M. Svane10, A.M. Arance Fernandez11, C.U. Blank12, B. Neyns13
  • 1Oncology, UZ Brussel, 1090 - Brussels/BE
  • 2Immunology And Medical Oncology, Het Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI-AVL), 1006 BE - Amsterdam/NL
  • 3Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen/DK
  • 4Medical Oncology, Het Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI-AVL), Amsterdam/NL
  • 5Medical Oncology, UZ Brussel, 1090 - Brussels/BE
  • 6Department Of Medical Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL
  • 7Onkologisk Afdeling R, Odense University Hospital, 5000 - Odense C/DK
  • 8Dept. Of Oncology, Aarhus University Hospital, DK-8000 - Aarhus C/DK
  • 9Department Of Medical Oncology, The Netherlands Cancer Institute, 1066 CX - Amsterdam/NL
  • 10Department Of Hematology And Oncology, Center for Cancer Immune Therapy, Herlev University Hospital, 2730 - Herlev/DK
  • 11Oncology, Hospital de Barcelona, Barcelona/ES
  • 12Dept Medical Oncology, The Netherlands Cancer Institute, 1066CX - Amsterdam/NL
  • 13Medical Oncology, Vrije Universiteit Brussel-Campus Jette, 1090 - Brussels/BE



The PD-1 blocking mAb pembrolizumab (PEMBRO) is approved for the treatment of patients (pts) with advanced melanoma. Correlation between baseline characteristics and outcome of pts treated outside of a prospective clinical trial has not been established.


Using Kaplan-Meier statistics, log-rank testing and multivariate Cox-regression analysis, correlations were investigated between baseline variables and PFS and OS in pts with advanced melanoma who received PEMBRO outside a clinical trial. An independent confirmatory cohort (CC) of pts from the Netherlands and Spain served to confirm correlations found in an exploratory Belgian cohort (EC). Additional data from 180 Scandinavian pts are being collected.


All pts in the EC (N = 123) and CC (N = 165) received at least one administration of PEMBRO (2 mg/kg q3wks). Baseline characteristics of the total cohort (TC) (N = 288) were: median age 60y (range 27-93); 49% Male; 61% performance score (PS) 0; primary site: 80% skin, 15% UKN, 4% mucosal; 49% BRAF V600mut; 76% AJCC stage IV-M1c; 29% brain metastases; 82% pretreated; 48% CRP >ULN; 33% LDH >ULN; 16% absolute lymphocyte count (ALC)  1.5ULN, CRP > 5xULN or ALC  1.5ULN with a typical “lower PFS plateau" beyond 30 wks. All pts with a baseline ALC  1.5xULN and CRP > 5xULN as independent unfavorable prognostic factors for PFS/OS.


While confirming encouraging survival outcome of advanced melanoma patients treated with PEMBRO outside a clinical trial setting, significant correlations were found between baseline PS, ALC, LDH, CRP and survival.

Clinical trial identification


Legal entity responsible for the study

UZ Brussel


UZ Brussel, NKI AVL


J.V. van Thienen: advisory role Bristol-Myers-Squibb and MSD. J.B.A.G. Haanen: advisory role: MSD, Pfizer, Bristol-Myers-Squibb, Novartis, Neon Therapeutics and Roche/Genentech. Research grant: MSD, BMS, GSK. C. Blank: advisory role: MSD, Pfizer, Bristol-Myers-Squibb, Novartis, GSK, Roche/Genentech, Lilly. Research grant: Novartis. B. Neyns: Personal compensation: Roche, Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis, AstraZeneca, CryoStorage for public speaking, consultancy and participation in advisory board meetings. All other authors have declared no conflicts of interest.