Williams Cancer Institute

The Potential of Intratumoral Immunotherapies: A Path Forward

Intratumorally delivered immunotherapies hold promise for altering the local tumor microenvironment and stimulating systemic host immunity. These therapies offer a potential alternative or complement to existing local and systemic treatments for cancer. However, despite their potential, they have seen limited success in late-phase trials for advanced cancers, resulting in few formal approvals. To address this, the Society for Immunotherapy of Cancer (SITC) convened a panel of experts to determine how to design clinical trials that best demonstrate the benefits of intratumoral immunotherapy for cancer patients at all stages of the disease.

An Intratumoral Immunotherapy Clinical Trials Expert Panel was assembled, consisting of international key stakeholders from academia and industry. The panel was surveyed using a multiple choice/free response format, and the results were discussed during a half-day consensus meeting. The key points from these discussions are summarized in the following manuscript.

The panel identified unique clinical trial designs tailored to different stages of cancer development, from premalignant to unresectable/metastatic stages, aimed at maximizing the chances of demonstrating the effects of intratumoral immunotherapies. The discussion covered various design elements, including study type, patient stratification and exclusion criteria, indications for randomization, study arm determination, endpoints, biological sample collection, and response assessment using biomarkers and imaging.

They also prioritized populations for studying intratumoral immunotherapy, focusing on the stage, type of cancer, and line of treatment. Additionally, the panel discussed common barriers to developing these local treatments and how to overcome them.

The SITC Intratumoral Immunotherapy Clinical Trials Expert Panel has outlined key considerations for designing and implementing studies with the greatest potential to capture the effects of intratumorally delivered immunotherapies. By creating more effective and standardized trial designs, the potential of intratumoral immunotherapy can be realized. This could lead to regulatory approvals that extend the benefits of these local treatments to the patients who need them the most.

Reference: Jason J Luke, Diwakar Davar, Robert H Andtbacka, Nina Bhardwaj, Joshua D Brody, Jason Chesney, Robert Coffin, Thierry de Baere, Tanja D de Gruijl, Matthew Fury, Gregory Goldmacher, Kevin J Harrington, Howard Kaufman, Ciara M Kelly, Anuradha D Khilnani, Ke Liu, Sherene Loi, Georgina V Long, Ignacio Melero, Mark Middleton, Bart Neyns, David J Pinato, Rahul A Sheth, Stephen B Solomon, Philippe Szapary, Aurelien Marabelle. (April 18, 2024). Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease. https://jitc.bmj.com/content/12/4/e008378

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