On January 14, 2025 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, and Georgetown University’s Lombardi Comprehensive Cancer Center reported a collaboration to explore the effectiveness of immune system profiling to monitor patients with gastrointestinal (GI) cancers receiving combinations of immunotherapy and anti-VEGF inhibitors in the microscopic residual disease (MRD) setting (Press release, BostonGene, JAN 14, 2025, View Source [SID1234649728]).
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Currently, surveillance for GI cancer patients having undergone curative-intent procedures relies on radiologic imaging and non-specific lab tests with poor sensitivity, often detecting relapse only after it has advanced. Biomarkers, such as circulating tumor DNA (ctDNA), have emerged as non-invasive blood tests with the ability to identify the earliest signs of cancer relapse, or MRD. This multi-institution feasibility study aims to identify high-risk patients with GI cancers who have completed standard of care curative-intent therapies but have MRD in the surveillance setting, defined by detectable ctDNA but no evidence of radiographic relapse. These high-risk patients are then treated with combination of atezolizumab (immune checkpoint blockade) and bevacizumab (anti-VEGF therapy) while assessing ctDNA serially for MRD clearance. The study aims to obtain pilot data on ctDNA as a new tool to detect early signals of therapeutic efficacy within months of starting treatment.
Immune system profiling, a non-invasive blood-based tool can detect unique and specific cancer-driven changes in a patient’s immunity often not detected by conventional methods. In this trial, the investigators hope to characterize the baseline and on-treatment changes in the peripheral blood immune profiles of patients with MRD receiving immunotherapy. Evaluating peripheral blood immune profiles as predictive biomarkers is promising in the MRD setting where tumor biopsies are not feasible and systemic immune surveillance is relevant in eradicating micrometastases.
The pioneering study will explore immune system profiling as a new predictive marker of therapeutic response. By tracking immune system profiling and ctDNA trends post-treatment, it aims to generate pilot data on immune system profiling’s feasibility in guiding treatment and improving outcomes in GI cancer patients.
"We need new approaches for improving outcomes for patients with gastrointestinal cancers," said principal investigator John L. Marshall, MD, director of the Ruesch Center for the Cure of GI Cancers at Georgetown Lombardi. "If we can validate immune system profiling as a reliable early marker of MRD, it would be a pivotal step towards enhancing early detection, optimizing treatment strategies, and ultimately preventing relapse." Marshall treats patients at MedStar Georgetown University Hospital.
"If we can demonstrate feasibility of enrolling patients and clearing ctDNA with immunotherapy in this pilot study, it could lead to future validation studies of novel therapeutics in the MRD setting and ctDNA as a surrogate for survival with the hopes of expediting drug discovery in the adjuvant and post-adjuvant settings," said co-principal investigator Reetu Mukherji, MD, assistant professor of medicine at Georgetown and co-writer of the study. "Additionally, our study will incorporate correlative science to study the yet unknown peripheral blood immune profiles of patients with MRD using the BostonGene peripheral blood profiling assay. Most ICI biomarkers studied to date are based on molecular or immune profiling of tumor tissue or molecular testing of ctDNA. However, liquid immunoprofiling is an emerging technology that holds ICI biomarker promise and warrants further study. This study has the potential to identify novel predictive biomarkers and hopefully one day transform current approaches to improve survival rates for patients who have undergone curative treatment."
Marshall and Mukherji both treat patients at MedStar Health, Georgetown’s academic health system partner.
Using advanced molecular and immune profiling capabilities, BostonGene will characterize each patient’s immune environment, providing detailed insights into how immune system profiling trends correlate with therapeutic outcomes. This analysis will facilitate the identification of predictive biomarkers, potentially informing future clinical applications of immune system profiling for MRD monitoring. By utilizing advanced multiomic data analysis and immune system profiling technology, BostonGene will also deliver essential insights into how a patient’s immune changes during and after therapy.
"We are excited to collaborate with Georgetown Lombardi," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our expertise in molecular and immune profiling, combined with immune system analysis, has the potential to revolutionize how MRD is detected and managed in GI cancers. By providing critical insights into immune system dynamics, we empower clinicians to make more informed, timely treatment decisions, thereby improving patient outcomes and reducing relapse rates."