Society for Immunotherapy of Cancer Publishes Recommendations on Optimal Intratumoral Immunotherapy Clinical Trial (IICT) Design

The Society for Immunotherapy of Cancer (SITC) is pleased to announce the publication of a new manuscript "Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from pre-malignant to metastatic disease" in the Journal for ImmunoTherapy of Cancer.

MILWAUKEE, April 23, 2024 /PRNewswire-PRWeb/ -- The Society for Immunotherapy of Cancer (SITC) is pleased to announce the publication of a new manuscript "Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from pre-malignant to metastatic disease" in the Journal for ImmunoTherapy of Cancer.

While intratumoral immunotherapies have the potential to boost anti-tumor immune responses to overcome immunosuppressive tumor microenvironments, phase III trials evaluating them in late-stage disease have had limited success to date, in part due to the complex nature of these trials not fully adapted to assess local therapies. The aim for this manuscript is to provide guidance on how to design trials with the greatest likelihood of demonstrating the benefits of intratumoral immunotherapy across all stages of pathogenesis and ultimately bring more effective options to patients.

"Intratumoral delivery has great potential to deliver precise and potent immunotherapies to particular disease sites and tumor microenvironments. Despite this, clinical development of intratumoral immunotherapies in metastatic cancer has been fraught with negative clinical trials and many open questions." said Jason Luke, MD, FACP, chair of the SITC Intratumoral Immunotherapy Clinical Trials Manuscript Development Group. "With the recommendations provided in the manuscript, researchers can optimize clinical trial design and the delivery of intratumoral immunotherapies."

Expert Panel Recommendations for Trial Design
To address challenges in intratumoral immunotherapy clinical trial design, an Expert Panel comprised of an international group of leaders from academia and industry convened to develop guidance on a variety of design elements including:

•     Patient stratification factors
•     Exclusion criteria
•     Study arm considerations
•     Optimal endpoints
•     Response assessment
•     Patient populations to prioritize

Supplemental Guidance on Localized Therapy Administration
A critical component for the development of intratumoral immunotherapies is identifying a standardized process for monitoring and documenting drug injection/application. As an additional educational tool for readers, an illustrated supplement accompanies the manuscript to instruct users on the proper administration of localized immunotherapies for solid tumors and lymphomas, subcutaneous lymph nodes from lymphoma or metastatic tumors, accessible head and neck, liver, and breast lesions, and intravesical immunotherapy.

While intratumoral immunotherapy is a potentially effective monotherapy when used in the optimal disease settings, it may also increase the effectiveness of systemic treatments without the cost of added toxicity. With more effective and standardized trial designs, the potential of intratumoral immunotherapy can be realized and lead to regulatory approvals that will extend the benefit of these local treatments to the patients who need them the most.

About SITC
Established in 1984, the Society for Immunotherapy of Cancer (SITC) is a nonprofit organization of medical professionals dedicated to improving patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology. SITC is comprised of influential basic and translational scientists, practitioners, health care professionals, government leaders and industry professionals around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC aims to one day make the word "cure" a reality for cancer patients everywhere. Learn more about SITC, our educational offerings, and other resources at sitcancer.org and follow us on X, LinkedIn, Facebook and YouTube.

About JITC
The Journal for ImmunoTherapy of Cancer (JITC) is the official open access, peer-reviewed online journal of SITC. The journal publishes high-quality articles on all aspects of tumor immunology and cancer immunotherapy on subjects across the basic science-translational-clinical spectrum. JITC publishes original research articles, literature reviews, position papers, clinical practice guidelines, and case reports; invited commentaries may also be commissioned by the journal editors. These articles, freely accessible at jitc.bmj.com, make JITC the leading forum for tumor immunology and cancer immunotherapy research. Follow JITC on Twitter @jitcancer.

Media Contact

Thomas Martin, Society for Immunotherapy of Cancer, 414.271.2456, [email protected], www.sitcancer.org

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SOURCE Society for Immunotherapy of Cancer