Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors
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 patient...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-03-01
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| Series: | Journal for ImmunoTherapy of Cancer |
| Online Access: | https://jitc.bmj.com/content/11/3/e005921.full |
| _version_ | 1827807917875658752 |
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| author | Harriet Kluger Omid Hamid Roberta Zappasodi Michael Hurwitz Hussein Tawbi Elad Sharon Theresa LaVallee Rebecca A Moss Justin F Gainor J Carl Barrett Ryan J Sullivan |
| author_facet | Harriet Kluger Omid Hamid Roberta Zappasodi Michael Hurwitz Hussein Tawbi Elad Sharon Theresa LaVallee Rebecca A Moss Justin F Gainor J Carl Barrett Ryan J Sullivan |
| author_sort | Harriet Kluger |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T22:03:48Z |
| format | Article |
| id | doaj.art-6400d9b9bb3148028d7abaef119802cc |
| institution | Directory Open Access Journal |
| issn | 2051-1426 |
| language | English |
| last_indexed | 2024-03-11T22:03:48Z |
| publishDate | 2023-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Journal for ImmunoTherapy of Cancer |
| spelling | doaj.art-6400d9b9bb3148028d7abaef119802cc2023-09-25T09:30:07ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262023-03-0111310.1136/jitc-2022-005921Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitorsHarriet Kluger0Omid Hamid1Roberta Zappasodi2Michael Hurwitz3Hussein Tawbi4Elad Sharon5Theresa LaVallee6Rebecca A Moss7Justin F Gainor8J Carl Barrett9Ryan J Sullivan109 Yale School of Medicine, New Haven, Connecticut, USAThe Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, Los Angeles, California, USA7 Division of Hematology & Medical Oncology, Department of Medicine, Weill Cornell Medicine, New York, New York, USASchool of Medical Oncology, Yale School of Medicine, New Haven, Connecticut, USA11 University of Texas MD Anderson Cancer Center, Houston, Texas, USA4 Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland, USACoherus Biosciences, Redwood City, California, USA6 Bristol Myers Squibb, New York, New York, USA3 Massachusetts General Hospital, Boston, Massachusetts, USA2 Translational Medical Oncology, AstraZeneca, Boston, Massachusetts, USADepartment of Medicine, Harvard Medical School, Boston, Massachusetts, USAImmunotherapy 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.https://jitc.bmj.com/content/11/3/e005921.full |
| spellingShingle | Harriet Kluger Omid Hamid Roberta Zappasodi Michael Hurwitz Hussein Tawbi Elad Sharon Theresa LaVallee Rebecca A Moss Justin F Gainor J Carl Barrett Ryan J Sullivan Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors Journal for ImmunoTherapy of Cancer |
| title | Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors |
| title_full | Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors |
| title_fullStr | Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors |
| title_full_unstemmed | Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors |
| title_short | Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors |
| title_sort | society for immunotherapy of cancer sitc consensus definitions for resistance to combinations of immune checkpoint inhibitors |
| url | https://jitc.bmj.com/content/11/3/e005921.full |
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