data showed that CytoSite’s Granzyme B (GzmB) PET imaging using [68Ga-NOTA]-hGZP (CSB-111) was feasible and safe in human subjects. These data come from a Phase I trial assessing the safety and feasibility of GzmB PET imaging in subjects with melanoma and non-small cell lung cancer (NSCLC) receiving KEYTRUDA (pembrolizumab).

December 14, 2022 —  CytoSite Bio, a company developing precision imaging products that determine patient response to immuno-oncology therapy today shared new data at the Radiological Society of North American (RSNA) Annual Meeting in Chicago, IL. In an oral presentation titled “Interim analysis of a first-in-human first-in-class phase I study of Granzyme B PET imaging for assessing single agent immune checkpoint inhibition response in melanoma and non-small cell lung cancer,” data showed that CytoSite’s Granzyme B (GzmB) PET imaging using [68Ga-NOTA]-hGZP (CSB-111) was feasible and safe in human subjects. These data come from a Phase I trial assessing the safety and feasibility of GzmB PET imaging in subjects with melanoma and non-small cell lung cancer (NSCLC) receiving KEYTRUDA (pembrolizumab). 

“The interim analysis of data in the first eight subjects who underwent imaging from this study clearly demonstrates the promise of Granzyme B PET imaging as a tool to optimize cancer immunotherapy treatment decisions,” said Ryan Sullivan, MD, Associate Professor of Hematology & Oncology at Massachusetts General Hospital and Principal Investigator of the study. “This non-invasive approach has the potential to inform physicians of the efficacy of the immunotherapy within weeks of the first immunotherapy dose rather than waiting for several months and often multiple scans to confirm response or progression, allowing for a rapid change in treatment which could save lives and transform the immune-oncology landscape. I am pleased that these early, promising data are showing how that option could become a reality.” 

CSB-111, a radiopharmaceutical which identifies Granzyme B released from the NK and T-Cells in the tumor, was shown to have favorable biodistribution and rapid clearance. Interim analysis of the first eight subjects showed that all tolerated the imaging well. As expected, subjects that showed robust uniform uptake above the blood pool in the lesions showed treatment response to ICI with continued disease remission during the 6-month follow-up, while subjects with low-level lesion uptake clearly below the blood pool level had progression on therapy. 

“The data presented today validate CytoSite’s belief that our work to use PET imaging to detect Granzyme B has the potential to transform outcomes in immuno-oncology,” said Jim Jenson, PhD, Co-founder and CEO of CytoSite. “If approved, our proprietary biomarker and approach to imaging could provide better tools for our oncologists to enable improved outcomes for patients with cancer and rapidly expanding options for new immunotherapies. These data represent a fantastic step toward our ultimate goal, and we look forward reporting results from our Phase 1/2 study upon study completion.” 

For more information: https://www.cytositebio.com/ 

Find more RSNA22 coverage here  


Related Content

News | Radiation Therapy

October 2, 2023 — A type of head and neck cancer predominantly diagnosed in people who reside in low- and middle-income ...

Time October 02, 2023
arrow
News | Stereotactic Body Radiation Therapy (SBRT)

October 1, 2023 — Older adults diagnosed with kidney tumors that are not suitable for surgery may benefit from targeted ...

Time October 01, 2023
arrow
News | Prostate Cancer

September 29, 2023 — People with intermediate risk, localized prostate cancer can be treated as effectively using fewer ...

Time September 29, 2023
arrow
News | Computed Tomography (CT)

September 29, 2023 —Nano-X Imaging, an innovative medical imaging technology company, today announced that HealthCCSng ...

Time September 29, 2023
arrow
News | Radiation Therapy

September 28, 2023 — RefleXion Medical, a therapeutic oncology company, announced the company will showcase the ...

Time September 28, 2023
arrow
News | Magnetic Resonance Imaging (MRI)

September 28, 2023 — Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Magnetom ...

Time September 28, 2023
arrow
News | Breast Imaging

September 27, 2023 — Researchers at Weill Cornell Medicine have discovered that radiation therapy combined with two ...

Time September 27, 2023
arrow
News | Lung Imaging

September 26, 2023 — In a study of more than 2,000 chest X-rays, radiologists outperformed AI in accurately identifying ...

Time September 26, 2023
arrow
Feature | Magnetic Resonance Imaging (MRI) | By Robert L. Bard, MD, and Lennard M. Gettz, EdD

Since the advent of the magnetic resonance imaging (MRI) exam on human patients in the late 1970s, this innovation ...

Time September 25, 2023
arrow
News | Cardiac Imaging

September 21, 2023 — Declines in cardiovascular procedure volumes observed early in the COVID-19 pandemic greatly ...

Time September 21, 2023
arrow
Subscribe Now