Anti PD-1/L1 (PD1) agents are being used to treat various tumor types. Most trials have excluded patients (pts) who have had a solid organ transplant (SOT), HIV, or Hepatitis (Hep) B and Hepatitis C. The safety and efficacy of PD1 in this setting is unknown.
Pts treated at 16 centres that had a transplant, HIV, Hep B/C were included. Patient demographics, tumour characteristics, toxicity, response and survival data, and the effect on the underlying condition were collected.
42 pts were identified; 29 with melanoma, 6 bladder carcinoma (BC), 2 hepatocellular carcinoma (HCC), 2 renal cell carcinoma (RCC), 2 mesothelioma (meso), and 1 each of gastric carcinoma, glioblastoma multiforme (GBM) and non-small cell lung cancer (NSCLC). 5 pts with SOT (4 renal,1 liver) had melanoma received pembrolizumab; 3 had progressive disease (PD), 1 partial response (PR), and the pt with liver transplant had graft rejection and died from this after 1 dose. 11 pts had HIV; 2 with detectable viral load. 8 pts had pembrolizumab (7 melanoma, 1 HCC), 2 nivolumab (1 melanoma, 1 RCC) and 1 atezolizumab (BC). No pt had loss in viral control or immune reconstitution inflammatory syndrome. 2 had complete response (CR), 1 PR, 4 stable disease (SD) and 4 PD. 14 pts had Hep C; 9 with detectable viral load, 6 on anti-viral therapy and 5 with cirrhosis. 6 received pembrolizumab (5 melanoma, 1 meso), 7 nivolumab (4 melanoma, 1 each of NSCLC, BC, RCC) and 1 atezolizumab (BC). No pt had loss in viral control, 1 developed grade 3 colitis but no one developed hepatitis. 2 had CR, 9 SD and 3 PD. 12 pts with Hep B; 8 with detectable viral load, 6 on anti-viral therapy and none with cirrhosis. 8 had pembrolizumab (5 melanoma, 1 each of GBM, gastric carcinoma and meso), 4 nivolumab (2 melanoma, 1 BC, 1 HCC). No pt had loss in viral control.1 had CR, 1 PR, 8 SD and 2 PD. None of Hep B or Hep C pts developed immune related hepatits.
Immunotherapy appears to have activity in patients with SOT, HIV and Hep B and Hep C. It can be given to renal transplant pts without rejection, however this is not universal . PD1 does not appear to adversely affect the viral control in HIV and Hep B and Hep C pts.
Clinical trial identification
Legal entity responsible for the study
Human ethics approved protocol at Melanoma Institute Australia
L. Zimmer: Honoraria: Roche. S. Goldinger: Research funding from the Zurich University Hospital and received travel grant support from Novartis, Roche, MSD and Bristol-Myers Squibb. An intermittent advisory board relationship with Novartis, Roche, MSD and Bristol-Myers Squibb. M. Millward: grant support from GlaxoSmithKline during the conduct of the study and other support from GlaxoSmithKiline. V. Atkinson: advisory boards and received travel support and speaker\'s fees from Bristol-Myers Squibb, Novartis and MSD. GVL is a consultant advisor to Amgen, Merck MSD, Novartis and Roche received honoraria from Bristol-Myers Squibb, Novartis and Merck MSD. P.A. Ascierto: receiving consulting fees from Bristol-Myers Squibb, Roche, GSK, MSD, Ventana Medical Systems, Novartis, and Amgen, honoraria from Bristol-Myers Squibb, Roche, and GSK, and grant support to his institution from Bristol-Myers Squibb, Roche, and Ventana Medical Systems; C. Garbe: Advisory board: AMGEN, Bristol-Myers Squibb, GSK, MSD, Novartis and Roche Lecture honorarium: Bristol-Myers Squibb, MSD Consulting: Roche. R. Gutzmer: Received project support from Novartis Pharma and Pfizer Lecture honoraria from Novartis Pharma and Pfizer. D.B. Johnson: personal fees from Genoptix and Bristol-Myers Squibb. G.V. Long: personal fees from GlaxoSmithKline during the conduct of the study and personal fees from Roche, Novartis, Amgen, and Bristol Myers Squibb. A.M. Menzies: honoraria from Bristol-Myers Squibb and Novartis, and has sat on advisory boards for MSD and Chugai All other authors have declared no conflicts of interest.