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Genitourinary tumours, non-prostate

2577 - Axitinib in combination with pembrolizumab in patients (pts) with advanced renal cell carcinoma (aRCC): Preliminary safety and efficacy results


09 Oct 2016


Genitourinary tumours, non-prostate


Michael Atkins


Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373


M.B. Atkins1, E.R. Plimack2, I. Puzanov3, M.N. Fishman4, D. McDermott5, D.C. Cho6, U. Vaishampayan7, S. George8, T. Olencki9, J. Tarazi10, B. Rosbrook10, K. Fernandez11, S. Keefe12, T.K. Choueiri13

Author affiliations

  • 1 Medical Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 20057 - Washington/US
  • 2 Department Of Hematology/oncology, Fox Chase Cancer Center, PA 19111-2497 - Philadelphia/US
  • 3 Hematology Oncology, Vanderbilt Ingram Cancer Center, 37232 - Nashville/US
  • 4 Medical Oncology, H. Lee Moffitt Cancer Center University of South Florida, Tampa/US
  • 5 Division Of Hematology/oncology, Beth Israel Deaconess Med. Center, 02215 - Boston/US
  • 6 Medical Oncology, NYU Langone Medical Center, 10016 - New York/US
  • 7 Medical Oncology, Karmanos Cancer Institute, Detroit/US
  • 8 Department Of Medicine, Roswell Park Cancer Institute, 14263 - Buffalo/US
  • 9 Medical Oncology, Ohio State Univ Medical Center, 43210 - Columbus/US
  • 10 Oncology, Pfizer Inc, San Diego/US
  • 11 Onclology, Pfizer, Cambridge/US
  • 12 Oncology, Merck & Co., Inc., Kenilworth/US
  • 13 Medical Oncology, Dana-Farber cancer Institute, Boston, MA/US


Abstract 2577


Axitinib, an inhibitor of vascular endothelial growth factor receptors, is approved for 2nd-line treatment of aRCC. Pembrolizumab is a humanized monoclonal antibody that blocks binding of the immune-checkpoint receptor programmed death-1 (PD-1) to its ligands (PD-L1/2). Here we report preliminary safety and efficacy results from an ongoing phase Ib study of axitinib plus pembrolizumab in treatment-naïve pts with aRCC.


Pts included have clear-cell aRCC with primary tumor resected, ≥1 measureable lesion, ECOG performance status 0-1, controlled hypertension, and no prior systemic therapy for aRCC. Axitinib is administered orally 5 mg twice daily; pembrolizumab is administered 2 mg/kg intravenously on Day 1 of each 3-week cycle. Tumors are assessed, using RECIST v1.1, at baseline, week 12, and every 6 weeks thereafter. Study endpoints include adverse events (AEs), other safety measures and tumor response. IHC-based assay was used to stain tumor cells for PD-L1 expression.


As of March 1, 2016, 52 pts (79% male; 87% white; mean age 61 years) were enrolled. Eleven (21.2%) pts discontinued both treatments: disease progression (n = 4); treatment-emergent AEs (n = 6; diarrhea, headache/joint pain, fatigue/joint pain, colitis/hepatitis, aggravated rheumatoid arthritis/psoriasis, and drug-induced liver injury); and other (n = 1). Thirty-five (67.3%) pts had objective response: 2 had complete response and 33 had partial responses; 11 pts had stable disease. For the 11 pts enrolled in the dose finding phase, 7 remained progression free at 11 months and the median PFS is not yet mature. Ten pts tested positive for PD-L1. Most common (>2 pts) grade 3 AEs included hypertension (n = 10), diarrhea, headache, hyponatraemia, alanine aminotransferase (ALT) increased, and aspartate aminotransferase (AST) increased (n = 3 each). Grade 4 AEs included dyspnea and hyperuricaemia (n = 1 each). Immune-related ≥grade 3 AEs included ALT and AST (n = 2 each), and diarrhea and colitis (n = 1 each).


This preliminary analysis indicates axitinib plus pembrolizumab is well tolerated and exhibits antitumor activity in treatment-naïve pts with aRCC.

Clinical trial identification


Legal entity responsible for the study

Pfizer Inc


Pfizer Inc


M.B. Atkins: declares receiving fees for consulting BMS, Pfizer, Novartis, Genentech-Roche, Merck, Amgen, Nektar, Eisai, AstraZeneca, GlaxoSmithKline, Peleton, and Acceleron. E.R. Plimack: consulting fees from Merck, GlaxoSmithKline, Pfizer, Bristol-Myers SquibbNovartis, Acceleron and Genentech/Roche, and grant support to her institution from Bristol-Myers Squibb, AstraZeneca, Peloton, Merck, GlaxoSmithKline, Acceleron, and Pfizer. M.N. Fishman: research funding from Amgen, Altor Biosciences, AstraZeneca, Aveo, Bayer, Bristol-Myers Squibb, Eisai, Exelixis, Genentech, GlaxoSmithKline, Merck, and Pfizer; speakers bureaus from Bayer, Exelixis, GlaxoSmithKline, Novartis, Pfizer, and Prometheus. D. McDermott: declares receiving fees for consulting BMS, Pfizer, Novartis, Genentech-Roche, Merck, and Exelixis. D.C. Cho: declares receiving fees for consulting from Pfizer, Genentech, Prometheus, Bristol-Meyers Squibb, and Exelixis. U. Vaishampayan: Consulting, honoraria and research support from Pfizer Inc and research support from Merck Inc. S. George: fees for consulting and advisory boards from Pfizer, Exelixis, Bristol-Myers Squibb, Novartis, Bayer, Sanofi-Aventis, Astellas, Xcenda, and Onclive, and grant support from Bristol-Myers Squibb, Novartis, Bayer, Pfizer, Acceleron, Merck, and Agensys. J. Tarazi: an employee of and own stock in Pfizer. B. Rosbrook: an employee of and own stock in Pfizer. K. Fernandez: an employee of and own stock in Pfizer. S. Keefe: an employee of Merck & Co., Inc. T. Choueiri: fees for consulting, advisory boards: GSK, Novartis, Pfizer, Merck, AstraZeneca, Bayer, Prometheus; grant support through his institution: Bristol-Myers Squibb, GSK, Novartis, Exelixis, Pfizer, Merck, Roche, AstraZeneca, TRACON, Peloton. All other authors have declared no conflicts of interest.

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