CD8 PET imaging with [89Zr]Zr-berdoxam-crefmirlimab in patients with solid tumors: the Phase II iCorrelate study

Publication Title

J Immunother Cancer

Authors

• Michael A Postow
• Peter D Zang
• Sumanta K Pal
• Audrey Mauguen
• Michael Farwell
• Michael Gordon
• David Hays
• Jeffrey Y C Wong
• Delphine Chen
• Gary A Ulaner
• Giuseppe Esposito
• Jonathan McConathy
• Michael M Graham
• Anthony F Shields
• Annick D Van den Abbeele
• Marcus O Butler
• Jacob S Thomas
• Przemyslaw Twardowski, Providence Saint John's Health Center, Santa Monica, CA USAFollow
• Jayant Narang
• Aman P Singh
• Agnish Dey
• Kevin P Maresca
• Edmund Keliher
• Feng Liu
• Guillaume Potdevin
• Guenter Schmidt
• William Le
• Ian Wilson
• Alessandro Mascioni
• Fang Jia
• Ronald Korn
• Michael R Ferris
• Kristin Schmiedehausen
• Neeta Pandit-Taskar
• Kim A Margolin

Document Type

Article

Publication Date

3-27-2026

Keywords

california; santa monica; psjhc

Abstract

Background: CD8 T cells mediate the effects of cancer immunotherapies. CD8 positron emission tomography (PET) imaging with [89Zr]Zr-berdoxam-crefmirlimab enables whole body CD8 cell assessment and has been shown to be safe in Phase I evaluation. The correlation between CD8 PET imaging parameters and the quantity of CD8 cells assessed by the gold standard of immunohistochemistry (IHC) is unknown.

Methods: The Phase II, prospective multicenter study (iCorrelate) tested the correlation between CD8 PET and CD8 cells by IHC of core needle biopsies from patients with solid tumors receiving immune checkpoint blockade. The safety of repeat CD8 PET was additionally analyzed.

Results: 49 patients had 70 biopsies (37 baseline and 33 on-treatment) for correlating CD8 PET with IHC. Standard uptake value mean of the biopsied tumor normalized to aorta showed a correlation with IHC of 0.49 (95% CI 0.26 to 0.59). The correlation was 0.71 (95% CI 0.48 to 0.85) in patients with renal cell carcinoma. Repeat CD8 PET imaging on-treatment was safe.

Conclusions: We found a modest correlation between CD8 PET with [89Zr]Zr-berdoxam-crefmirlimab and intratumoral CD8 cell counts, likely because core needle biopsies do not fully represent the intratumoral heterogeneity of the CD8 cell distribution. Continued research is essential to evaluate in vivo CD8 PET signals, autoradiography, and CD8 T-cell presence by IHC in fully resected tumors. Further studies investigating the correlation between CD8 PET and immunotherapy outcomes are necessary to determine whether CD8 PET imaging could become a valuable tool for guiding immunotherapy development and informing clinical decision-making.

Area of Special Interest

Cancer

Specialty/Research Institute

Oncology

Specialty/Research Institute

Pharmacy

DOI

10.1136/jitc-2025-012208