Professional Standards

Cancer Immunotherapy Guidelines Program

SITC's Cancer Immunotherapy Guidelines deliver evidence-based clinical practice guidelines (CPGs) developed by multi-disciplinary expert panels drawing on both published research and clinical trial data. These guidelines distill the rapidly evolving immunotherapy literature into clear, actionable recommendations to support cancer care providers in treatment planning. The program includes 16 CPGs covering hematologic malignancies, solid tumors, and toxicity management.

2025 CPG Living Guidelines Rapid Updates

SITC Living Guideline rapid update protocols are designed to keep SITC clinical practice guidelines current and reflective of the latest expert guidance in cancer immunotherapy care. Rapid updates are incorporated into existing published guidelines through an overlay system that highlights affected sections and provides revised text supported by updated data, evidence and references. Each rapid update documents the evolution of guidance through version numbering and a clearly identified “last reviewed” date. When more substantiative changes are required, updates are issued as an addendum to the original publication, establishing a new version of record.

In 2025, SITC updated four of our existing guidelines:

A special thank you to the co-chairs of the CPG Expert Panels:

Michael R. Bishop, MD

Michael R. Bishop, MD
University of Chicago
Lymphoma Guideline v1 Expert Panel Chair

Ramaswamy Govindan, MD

Ramaswamy Govindan, MD
Washington University School of Medicine
Lung Cancer and Mesothelioma Guideline v2 Expert Panel Chair

Roy S. Herbst, MD, PhD

Roy S. Herbst, MD, PhD
Yale Cancer Center
Lung Cancer and Mesothelioma Guideline v2 Expert Panel Chair

Ronan J. Kelly, MD, PhD

Ronan J. Kelly, MD, PhD
Baylor University Medical Center
Gastrointestinal Cancer Guideline v1 Expert Panel Chair

Dung Le, MD

Dung Le, MD
Johns Hopkins University School of Medicine
Gastrointestinal Cancer Guideline v1 Expert Panel Chair

Sattva S. Neelapu, MD

Sattva S. Neelapu, MD
University of Texas MD Anderson Cancer Center
Lymphoma Guideline v1 Expert Panel Chair

Anna C. Pavlick, MD, MBA

Anna C. Pavlick, MD, MBA
Weill Cornell Medicine
Melanoma Guideline v3 Expert Panel Chair

Ryan J. Sullivan, MD

Ryan J. Sullivan, MD
Harvard Medical School, Massachusetts General Hospital
Melanoma Guideline v3 Expert Panel Chair

Clinical Practice Guidelines in Development

Renal Cell Carcinoma CPG v3.0
Acute Leukemia CPG v2.0
Acute Leukemia CPG v2.0

Learn more: sitcancer.org/guidelines

ASTCT-SITC Joint Summit: Advancing the Discovery of Cell Therapy for Solid Tumors

The invitation-only ASTCT-SITC Joint Summit: Advancing the Discovery of Cell Therapy for Solid Tumors, was held in collaboration with the American Society for Transplantation and Cellular Therapy (ASTCT). The Summit convened 32 academic and industry stakeholders to assess the current state of solid tumor cell therapy in academic medical centers and identify key opportunities for advancement.

Discussions focused on manufacturing and process development, regulatory affairs and compliance, and clinical operations. Building on these discussions, participants continued to refine and expand the Summit’s key concepts into a collaborative manuscript, which has been submitted to the Journal of Transplantation and Cellular Therapy (JTCT) for publication in 2026.

A special thank you to our organizers

Michael Kalos, PhD

Michael Kalos, PhD
Next Pillar Consulting

Kedar Kirtane, MD

Kedar Kirtane, MD
Moffitt Cancer Center

Jason Luke, MD

Jason Luke, MD
Strand Therapeutics

Roisin O’Cearbhaill, MD

Roisin O’Cearbhaill, MD
Memorial Sloan Kettering Cancer Center

Certificate in Cancer Immunotherapy

SITC offers physicians and qualified healthcare providers the only comprehensive Certificate in Cancer Immunotherapy, designed to strengthen the knowledge and skills required to deliver effective and safe immunotherapy care. This program equips learners with a thorough understanding of cancer immunotherapies including checkpoint inhibitors, cell therapies and emerging modalities, as well as the recognition and management of treatment related side effects, supporting successful integration into clinical practice.

The Certificate in Cancer Immunotherapy is a self-paced, evidence-based curriculum comprising eight independent modules that may be completed individually or stacked to earn the SITC Graduate in Cancer Immunotherapy (SITC-G) certificate. Completion of the SITC-G signifies specialized training in cancer immunotherapy, and offers CME, CNE, CPE and MOC credits. .

134 learners registered for the SITC-G in 2025

To date, 225 people have completed the SITC-G

SITC plans to launch a new neoadjuvant immunotherapy module in 2026, further expanding the Certificate curriculum.

Learn more: sitcancer.org/certificate

Leveraging Biomarkers Initiative 

Following the 2025 Leveraging Biomarkers Workshop, SITC volunteers advanced several interconnected efforts focused on biomarker standardization, education, and identification. Key initiatives include:

Digital Pathology Summit

This planned summit will integrate basic and clinical science to advance characterization of the tumor microenvironment in support of novel immuno-oncology (IO) treatments and biomarker discovery. Dr. Carlo Bifulco and Dr. Tullia Bruno are leading the formation of a multidisciplinary organizing committee—including pathologists, immunologists, and industry representatives—to define the summit’s objectives and deliverables. The virtual summit is anticipated to take place in 2026.

Manuscript Development

Based on stakeholder feedback from the Workshop, SITC is pursuing the development of multiple manuscripts. Proposed topics include consensus metrics for evaluating tertiary lymphoid structures (TLS) and a broader examination of artificial intelligence applications in biomarker development. Both manuscripts are being proposed for inclusion in an upcoming Journal for ImmunoTherapy of Cancer (JITC) special series.

Data Sharing

Data sharing emerged as a key theme during the Workshop, with stakeholders emphasizing the need for improved biomarker characterization. Several publicly available datasets were shared with participants to demonstrate existing resources. Further exploration of data-sharing frameworks, including potential collaborations with industry, will continue in 2026.

Essential Biomarkers

Over the past several years, SITC has led efforts to develop data-driven, consensus-based recommendations for biomarker studies in early-phase immunotherapy clinical trials. This work culminated in the publication of a commentary in 2024 and a consensus manuscript in 2025. To promote adoption of these recommendations and ensure timely updates as the field evolves, SITC established the Essential Biomarkers Taskforce.

The Taskforce convened in 2025 to assess the current biomarker landscape and to develop an iterative commentary outlining recommended updates to the essential and emergent biomarkers identified in the 2025 publication. In addition to publishing updates, Taskforce members will leverage their professional networks and coalitions to encourage the integration of essential biomarkers into clinical trial protocols.

A special thank you to the Essential Biomarkers Taskforce Co-Chairs

Tricia R. Cottrell, MD, PhD

Tricia Cottrell, MD, PhD
Queen's University

Sumit Subudhi, MD, PhD

Sumit K. Subudhi, MD, PhD
The University of Texas MD Anderson Cancer Cente

Resistance

SITC continued its multi-year effort to clinically define resistance to PD-(L)1 therapies across multiple disease settings and treatment combinations. Building on previously published consensus manuscripts, the initiative is now focused on analyzing cooperative group data to validate and, where appropriate, refine existing resistance definitions. Looking ahead to 2026, the SITC Resistance Committee will further engage cooperative groups and industry partners to explore data-sharing opportunities aimed at evaluating resistance definitions in both early-stage and metastatic disease settings.

An abstract presented at ASCO further advanced SITC’s resistance initiative by applying the Society’s consensus PD-(L)1 resistance definitions to large SWOG cooperative group trials. The analyses showed promise in validating the clinical relevance of these definitions in advanced disease, while also generating data to inform potential refinements in the adjuvant setting. Together, this work demonstrates meaningful progress toward validating and strengthening standardized resistance definitions through real-world, cooperative group data. Looking ahead to 2026, the SITC Resistance Committee will further engage cooperative groups and industry partners to explore data-sharing opportunities aimed at evaluating resistance definitions in both early-stage and metastatic disease settings.

A special thank you to our organizers

Harriet Kluger, MD

Harriet Kluger, MD
Yale Cancer Center

Ryan Sullivan, MD

Ryan Sullivan, MD
Massachusetts General Hospital

Hussein Tawbi, MD PhD

Hussein Tawbi, MD PhD
The University of Texas MD Anderson Cancer Center