Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors.

TitleSociety for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors.
Publication TypeJournal Article
Year of Publication2023
AuthorsKluger H, J Barrett C, Gainor JF, Hamid O, Hurwitz M, LaVallee T, Moss RA, Zappasodi R, Sullivan RJ, Tawbi H, Sharon E
JournalJ Immunother Cancer
Volume11
Issue3
Date Published2023 Mar
ISSN2051-1426
KeywordsConsensus, Humans, Immune Checkpoint Inhibitors, Immunotherapy, Neoplasms, Societies, Medical
Abstract

Immunotherapy is the standard of care for several cancers and the field continues to advance at a rapid pace, with novel combinations leading to indications in an increasing number of disease settings. Durable responses and long-term survival with immunotherapy have been demonstrated in some patients, though lack of initial benefit and recurrence after extended disease control remain major hurdles for the field. Many new combination regimens are in development for patients whose disease progressed on initial immunotherapy. To guide clinical trial design and support analyses of emerging molecular and cellular data surrounding mechanisms of resistance, the Society for Immunotherapy of Cancer (SITC) previously generated consensus clinical definitions for resistance to single-agent anti-PD-1 immune checkpoint inhibitors (ICIs) in three distinct scenarios: primary resistance, secondary resistance, and progression after treatment discontinuation. An unmet need still exists, however, for definitions of resistance to ICI-based combinations, which represent an expanding frontier in the immunotherapy treatment landscape. In 2021, SITC convened a workshop including stakeholders from academia, industry, and government to develop consensus definitions for resistance to ICI-based combination regimens for improved outcome assessment, trial design and drug development. This manuscript reports the minimum drug exposure requirements and time frame for progression that define resistance in both the metastatic setting and the perioperative setting, as well as key caveats and areas for future research with ICI/ICI combinations. Definitions for resistance to ICIs in combination with chemotherapy and targeted therapy will be published in companion volumes to this paper.

DOI10.1136/jitc-2022-005921
Alternate JournalJ Immunother Cancer
PubMed ID36918224
PubMed Central IDPMC10016305
Grant ListUL1 TR001863 / TR / NCATS NIH HHS / United States