Whole body PD-L1 PET in patients with NSCLC and melanoma.

David K. Leung, Joop De langen, David Raunig, Anna-Larissa N. Niemeijer, Egbert F. Smit, Ronald Boellaard, David Vallez-Garcia, G. A. M. S. van Dongen, A. D. Windhorst, Marc C. Huisman, Andor W. J. M. Glaudemans, N. Harry Hendrikse, Ralph Adam Smith, Alex J. Poot, Dasa Lipovsek, David J. Donnelly, Samuel J. Bonacorsi, Linda M. Velasquez, Shuyan Du, Wendy Hayes

Research output: Contribution to journalMeeting AbstractAcademic

Abstract

Background: PD-(L)1 immunotherapy is effective in multiple tumors, including NSCLC and melanoma, but tumor PD-L1 IHC correlates only moderately with treatment outcome. This study aims to assess 1) safety of 18F-BMS-986192 (18F-PD-L1) in human, 2) PD-L1 quantification in tumors using 18F-PD-L1 PET, 3) PD-L1 PET correlation with IHC and treatment outcome, and 4) intra and inter subject tracer uptake variability. Methods: Pts with NSCLC (N = 10) and melanoma (N = 3) were included. At baseline, pts received a static or multiphase dynamic whole body PET scan after injecting 200 MBq 18F-BMS-986192. For NSCLC pts, (1) SUV(max, peak and mean) were measured for each delineable tumor (N = 32, 1-7 tumors/pt), (2) PD-L1 IHC (28.8 assay) was performed on the biopsy, and (3) response to Nivolumab therapy assessed by RECIST 1.1. Intra and inter subject variability and intraclass correlation were calculated using SUVs of all assessed tumors. Equal variance for PD-L1 status was evaluated by a Levene’s test. Four (3 female) pts underwent dosimetry study (ICRP 60). Results: No AEs related to radiotracer was observed. Dosimetry study demonstrated whole body exposure of 30 mGy at dose > 1400 MBq. Biodistribution among pts is comparable. PD-L1 IHC from 13 biopsied lesions were evaluated, 5 <1%, 4 ≥1%, and 4 ≥50%. Tumor tracer uptake was measured in NSCLC pts and categorized by PDL-1 IHC as ≥50% or <50%. Clinical trial information: 2015-004760-11. Tumor SUVs did not correlate with RECIST 1.1 assessment. Lesion heterogeneity was reflected in both inter and intra pt variability (CVinter = 41%, CVintra = 53%, ICC = 0.41 for SUVpeak). Levene’s test showed no significance in variability between the two PD-L1 categories. Conclusions: PET-imaging with 18F-BMS-986192 is safe and feasible in pts with NSCLC and melanoma. Pts with higher PD-L1 PET SUV have higher PD-L1 by IHC. Intra pt variability is similar to inter pt variability. With limited number of pts, no clear correlation of PET PD-L1 and tumor response is observed. A prospective study with this tracer is underway to further investigate 18F-BMS-986192 in understanding of PD-L1 expression.
Original languageEnglish
Pages (from-to)139-139
Number of pages1
JournalJournal of Clinical Oncology
Volume36
Issue number5_suppl
DOIs
Publication statusPublished - 2018

Cite this

Leung, David K. ; De langen, Joop ; Raunig, David ; Niemeijer, Anna-Larissa N. ; Smit, Egbert F. ; Boellaard, Ronald ; Vallez-Garcia, David ; van Dongen, G. A. M. S. ; Windhorst, A. D. ; Huisman, Marc C. ; Glaudemans, Andor W. J. M. ; Hendrikse, N. Harry ; Smith, Ralph Adam ; Poot, Alex J. ; Lipovsek, Dasa ; Donnelly, David J. ; Bonacorsi, Samuel J. ; Velasquez, Linda M. ; Du, Shuyan ; Hayes, Wendy. / Whole body PD-L1 PET in patients with NSCLC and melanoma. In: Journal of Clinical Oncology. 2018 ; Vol. 36, No. 5_suppl. pp. 139-139.
@article{d1869cd5001e4ff69b065dbcd9b0008a,
title = "Whole body PD-L1 PET in patients with NSCLC and melanoma.",
abstract = "Background: PD-(L)1 immunotherapy is effective in multiple tumors, including NSCLC and melanoma, but tumor PD-L1 IHC correlates only moderately with treatment outcome. This study aims to assess 1) safety of 18F-BMS-986192 (18F-PD-L1) in human, 2) PD-L1 quantification in tumors using 18F-PD-L1 PET, 3) PD-L1 PET correlation with IHC and treatment outcome, and 4) intra and inter subject tracer uptake variability. Methods: Pts with NSCLC (N = 10) and melanoma (N = 3) were included. At baseline, pts received a static or multiphase dynamic whole body PET scan after injecting 200 MBq 18F-BMS-986192. For NSCLC pts, (1) SUV(max, peak and mean) were measured for each delineable tumor (N = 32, 1-7 tumors/pt), (2) PD-L1 IHC (28.8 assay) was performed on the biopsy, and (3) response to Nivolumab therapy assessed by RECIST 1.1. Intra and inter subject variability and intraclass correlation were calculated using SUVs of all assessed tumors. Equal variance for PD-L1 status was evaluated by a Levene’s test. Four (3 female) pts underwent dosimetry study (ICRP 60). Results: No AEs related to radiotracer was observed. Dosimetry study demonstrated whole body exposure of 30 mGy at dose > 1400 MBq. Biodistribution among pts is comparable. PD-L1 IHC from 13 biopsied lesions were evaluated, 5 <1{\%}, 4 ≥1{\%}, and 4 ≥50{\%}. Tumor tracer uptake was measured in NSCLC pts and categorized by PDL-1 IHC as ≥50{\%} or <50{\%}. Clinical trial information: 2015-004760-11. Tumor SUVs did not correlate with RECIST 1.1 assessment. Lesion heterogeneity was reflected in both inter and intra pt variability (CVinter = 41{\%}, CVintra = 53{\%}, ICC = 0.41 for SUVpeak). Levene’s test showed no significance in variability between the two PD-L1 categories. Conclusions: PET-imaging with 18F-BMS-986192 is safe and feasible in pts with NSCLC and melanoma. Pts with higher PD-L1 PET SUV have higher PD-L1 by IHC. Intra pt variability is similar to inter pt variability. With limited number of pts, no clear correlation of PET PD-L1 and tumor response is observed. A prospective study with this tracer is underway to further investigate 18F-BMS-986192 in understanding of PD-L1 expression.",
author = "Leung, {David K.} and {De langen}, Joop and David Raunig and Niemeijer, {Anna-Larissa N.} and Smit, {Egbert F.} and Ronald Boellaard and David Vallez-Garcia and {van Dongen}, {G. A. M. S.} and Windhorst, {A. D.} and Huisman, {Marc C.} and Glaudemans, {Andor W. J. M.} and Hendrikse, {N. Harry} and Smith, {Ralph Adam} and Poot, {Alex J.} and Dasa Lipovsek and Donnelly, {David J.} and Bonacorsi, {Samuel J.} and Velasquez, {Linda M.} and Shuyan Du and Wendy Hayes",
year = "2018",
doi = "10.1200/JCO.2018.36.5_suppl.139",
language = "English",
volume = "36",
pages = "139--139",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "5_suppl",

}

Leung, DK, De langen, J, Raunig, D, Niemeijer, A-LN, Smit, EF, Boellaard, R, Vallez-Garcia, D, van Dongen, GAMS, Windhorst, AD, Huisman, MC, Glaudemans, AWJM, Hendrikse, NH, Smith, RA, Poot, AJ, Lipovsek, D, Donnelly, DJ, Bonacorsi, SJ, Velasquez, LM, Du, S & Hayes, W 2018, 'Whole body PD-L1 PET in patients with NSCLC and melanoma.' Journal of Clinical Oncology, vol. 36, no. 5_suppl, pp. 139-139. https://doi.org/10.1200/JCO.2018.36.5_suppl.139

Whole body PD-L1 PET in patients with NSCLC and melanoma. / Leung, David K.; De langen, Joop; Raunig, David; Niemeijer, Anna-Larissa N.; Smit, Egbert F.; Boellaard, Ronald; Vallez-Garcia, David; van Dongen, G. A. M. S.; Windhorst, A. D.; Huisman, Marc C.; Glaudemans, Andor W. J. M.; Hendrikse, N. Harry; Smith, Ralph Adam; Poot, Alex J.; Lipovsek, Dasa; Donnelly, David J.; Bonacorsi, Samuel J.; Velasquez, Linda M.; Du, Shuyan; Hayes, Wendy.

In: Journal of Clinical Oncology, Vol. 36, No. 5_suppl, 2018, p. 139-139.

Research output: Contribution to journalMeeting AbstractAcademic

TY - JOUR

T1 - Whole body PD-L1 PET in patients with NSCLC and melanoma.

AU - Leung, David K.

AU - De langen, Joop

AU - Raunig, David

AU - Niemeijer, Anna-Larissa N.

AU - Smit, Egbert F.

AU - Boellaard, Ronald

AU - Vallez-Garcia, David

AU - van Dongen, G. A. M. S.

AU - Windhorst, A. D.

AU - Huisman, Marc C.

AU - Glaudemans, Andor W. J. M.

AU - Hendrikse, N. Harry

AU - Smith, Ralph Adam

AU - Poot, Alex J.

AU - Lipovsek, Dasa

AU - Donnelly, David J.

AU - Bonacorsi, Samuel J.

AU - Velasquez, Linda M.

AU - Du, Shuyan

AU - Hayes, Wendy

PY - 2018

Y1 - 2018

N2 - Background: PD-(L)1 immunotherapy is effective in multiple tumors, including NSCLC and melanoma, but tumor PD-L1 IHC correlates only moderately with treatment outcome. This study aims to assess 1) safety of 18F-BMS-986192 (18F-PD-L1) in human, 2) PD-L1 quantification in tumors using 18F-PD-L1 PET, 3) PD-L1 PET correlation with IHC and treatment outcome, and 4) intra and inter subject tracer uptake variability. Methods: Pts with NSCLC (N = 10) and melanoma (N = 3) were included. At baseline, pts received a static or multiphase dynamic whole body PET scan after injecting 200 MBq 18F-BMS-986192. For NSCLC pts, (1) SUV(max, peak and mean) were measured for each delineable tumor (N = 32, 1-7 tumors/pt), (2) PD-L1 IHC (28.8 assay) was performed on the biopsy, and (3) response to Nivolumab therapy assessed by RECIST 1.1. Intra and inter subject variability and intraclass correlation were calculated using SUVs of all assessed tumors. Equal variance for PD-L1 status was evaluated by a Levene’s test. Four (3 female) pts underwent dosimetry study (ICRP 60). Results: No AEs related to radiotracer was observed. Dosimetry study demonstrated whole body exposure of 30 mGy at dose > 1400 MBq. Biodistribution among pts is comparable. PD-L1 IHC from 13 biopsied lesions were evaluated, 5 <1%, 4 ≥1%, and 4 ≥50%. Tumor tracer uptake was measured in NSCLC pts and categorized by PDL-1 IHC as ≥50% or <50%. Clinical trial information: 2015-004760-11. Tumor SUVs did not correlate with RECIST 1.1 assessment. Lesion heterogeneity was reflected in both inter and intra pt variability (CVinter = 41%, CVintra = 53%, ICC = 0.41 for SUVpeak). Levene’s test showed no significance in variability between the two PD-L1 categories. Conclusions: PET-imaging with 18F-BMS-986192 is safe and feasible in pts with NSCLC and melanoma. Pts with higher PD-L1 PET SUV have higher PD-L1 by IHC. Intra pt variability is similar to inter pt variability. With limited number of pts, no clear correlation of PET PD-L1 and tumor response is observed. A prospective study with this tracer is underway to further investigate 18F-BMS-986192 in understanding of PD-L1 expression.

AB - Background: PD-(L)1 immunotherapy is effective in multiple tumors, including NSCLC and melanoma, but tumor PD-L1 IHC correlates only moderately with treatment outcome. This study aims to assess 1) safety of 18F-BMS-986192 (18F-PD-L1) in human, 2) PD-L1 quantification in tumors using 18F-PD-L1 PET, 3) PD-L1 PET correlation with IHC and treatment outcome, and 4) intra and inter subject tracer uptake variability. Methods: Pts with NSCLC (N = 10) and melanoma (N = 3) were included. At baseline, pts received a static or multiphase dynamic whole body PET scan after injecting 200 MBq 18F-BMS-986192. For NSCLC pts, (1) SUV(max, peak and mean) were measured for each delineable tumor (N = 32, 1-7 tumors/pt), (2) PD-L1 IHC (28.8 assay) was performed on the biopsy, and (3) response to Nivolumab therapy assessed by RECIST 1.1. Intra and inter subject variability and intraclass correlation were calculated using SUVs of all assessed tumors. Equal variance for PD-L1 status was evaluated by a Levene’s test. Four (3 female) pts underwent dosimetry study (ICRP 60). Results: No AEs related to radiotracer was observed. Dosimetry study demonstrated whole body exposure of 30 mGy at dose > 1400 MBq. Biodistribution among pts is comparable. PD-L1 IHC from 13 biopsied lesions were evaluated, 5 <1%, 4 ≥1%, and 4 ≥50%. Tumor tracer uptake was measured in NSCLC pts and categorized by PDL-1 IHC as ≥50% or <50%. Clinical trial information: 2015-004760-11. Tumor SUVs did not correlate with RECIST 1.1 assessment. Lesion heterogeneity was reflected in both inter and intra pt variability (CVinter = 41%, CVintra = 53%, ICC = 0.41 for SUVpeak). Levene’s test showed no significance in variability between the two PD-L1 categories. Conclusions: PET-imaging with 18F-BMS-986192 is safe and feasible in pts with NSCLC and melanoma. Pts with higher PD-L1 PET SUV have higher PD-L1 by IHC. Intra pt variability is similar to inter pt variability. With limited number of pts, no clear correlation of PET PD-L1 and tumor response is observed. A prospective study with this tracer is underway to further investigate 18F-BMS-986192 in understanding of PD-L1 expression.

U2 - 10.1200/JCO.2018.36.5_suppl.139

DO - 10.1200/JCO.2018.36.5_suppl.139

M3 - Meeting Abstract

VL - 36

SP - 139

EP - 139

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 5_suppl

ER -