Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lung cancer and mesothelioma

Ramaswamy Govindan¹, Charu Aggarwal², Scott J Antonia³, Marianne Davies⁴, Steven M Dubinett⁵, Andrea Ferris⁶, Patrick M Forde⁷, Edward B Garon⁸, Sarah B Goldberg⁹, Raffit Hassan¹⁰, Matthew D Hellmann¹¹, Fred R Hirsch¹², Melissa L Johnson^{13

14}, Shakun Malik¹⁵, Daniel Morgensztern¹, Joel W Neal¹⁶, Jyoti D Patel¹⁷, David L Rimm¹⁸, Sarah Sagorsky⁷, Lawrence H Schwartz¹⁹, Boris Sepesi²⁰, Roy S Herbst²¹

Affiliations

¹ Department of Medicine, Oncology Division, Medical Oncology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA.
² Division of Hematology-Oncology, Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
³ Division of Medical Oncology, Department of Medicine, Duke Cancer Institute Center for Cancer Immunotherapy, Durham, North Carolina, USA.
⁴ Yale School of Nursing, Yale Cancer Center, New Haven, Connecticut, USA.
⁵ Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA.
⁶ LUNGevity Foundation, Chicago, Illinois, USA.
⁷ Upper Aerodigestive Division, Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
⁸ Division of Hematology/Oncology, Department of Medicine, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA.
⁹ Section of Medical Oncology, Yale University School of Medicine, Yale Cancer Center, New Haven, Connecticut, USA.
¹⁰ Thoracic and GI Malignancies Branch, National Cancer Institute, Bethesda, Maryland, USA.
¹¹ Memorial Sloan Kettering Cancer Center, New York, New York, USA.
¹² Center for Thoracic Oncology, Tisch Cancer Institute and Icahn School of Medicine at Mount Sinai, New York, New York, USA.
¹³ Sarah Cannon Research Institute, Nashville, Tennessee, USA.
¹⁴ Tennessee Oncology/One Oncology, Nashville, Tennessee, USA.
¹⁵ Division of Cancer Treatment & Diagnosis, CTEP, National Cancer Institute, Rockville, Maryland, USA.
¹⁶ Stanford Cancer Institute, Stanford University, Stanford, California, USA.
¹⁷ Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Evanston, Illinois, USA.
¹⁸ Department of Pathology, Yale University School of Medicine, New Haven, Connecticut, USA.
¹⁹ Department of Radiology, Vagelos College of Physicians and Surgeons, Columbia University Medical Center, New York, New York, USA.
²⁰ Department of Thoracic and Cardiovascular Surgery, Division of Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
²¹ Section of Medical Oncology, Yale University School of Medicine, Yale Cancer Center, New Haven, Connecticut, USA roy.herbst@yale.edu.

PMID: 35640927
PMCID: PMC9157337
DOI: 10.1136/jitc-2021-003956

Practice Guideline

Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lung cancer and mesothelioma

Ramaswamy Govindan et al. J Immunother Cancer. 2022 May.

. 2022 May;10(5):e003956.

doi: 10.1136/jitc-2021-003956.

Authors

Affiliations

¹ Department of Medicine, Oncology Division, Medical Oncology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA.
² Division of Hematology-Oncology, Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
³ Division of Medical Oncology, Department of Medicine, Duke Cancer Institute Center for Cancer Immunotherapy, Durham, North Carolina, USA.
⁴ Yale School of Nursing, Yale Cancer Center, New Haven, Connecticut, USA.
⁵ Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA.
⁶ LUNGevity Foundation, Chicago, Illinois, USA.
⁷ Upper Aerodigestive Division, Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
⁸ Division of Hematology/Oncology, Department of Medicine, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA.
⁹ Section of Medical Oncology, Yale University School of Medicine, Yale Cancer Center, New Haven, Connecticut, USA.
¹⁰ Thoracic and GI Malignancies Branch, National Cancer Institute, Bethesda, Maryland, USA.
¹¹ Memorial Sloan Kettering Cancer Center, New York, New York, USA.
¹² Center for Thoracic Oncology, Tisch Cancer Institute and Icahn School of Medicine at Mount Sinai, New York, New York, USA.
¹³ Sarah Cannon Research Institute, Nashville, Tennessee, USA.
¹⁴ Tennessee Oncology/One Oncology, Nashville, Tennessee, USA.
¹⁵ Division of Cancer Treatment & Diagnosis, CTEP, National Cancer Institute, Rockville, Maryland, USA.
¹⁶ Stanford Cancer Institute, Stanford University, Stanford, California, USA.
¹⁷ Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Evanston, Illinois, USA.
¹⁸ Department of Pathology, Yale University School of Medicine, New Haven, Connecticut, USA.
¹⁹ Department of Radiology, Vagelos College of Physicians and Surgeons, Columbia University Medical Center, New York, New York, USA.
²⁰ Department of Thoracic and Cardiovascular Surgery, Division of Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
²¹ Section of Medical Oncology, Yale University School of Medicine, Yale Cancer Center, New Haven, Connecticut, USA roy.herbst@yale.edu.

PMID: 35640927
PMCID: PMC9157337
DOI: 10.1136/jitc-2021-003956

Abstract

Immunotherapy has transformed lung cancer care in recent years. In addition to providing durable responses and prolonged survival outcomes for a subset of patients with heavily pretreated non-small cell lung cancer (NSCLC), immune checkpoint inhibitors (ICIs)- either as monotherapy or in combination with other ICIs or chemotherapy-have demonstrated benefits in first-line therapy for advanced disease, the neoadjuvant and adjuvant settings, as well as in additional thoracic malignancies such as small-cell lung cancer (SCLC) and mesothelioma. Challenging questions remain, however, on topics including therapy selection, appropriate biomarker-based identification of patients who may derive benefit, the use of immunotherapy in special populations such as people with autoimmune disorders, and toxicity management. Patient and caregiver education and support for quality of life (QOL) is also important to attain maximal benefit with immunotherapy. To provide guidance to the oncology community on these and other important concerns, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel of experts to develop a clinical practice guideline (CPG). This CPG represents an update to SITC's 2018 publication on immunotherapy for the treatment of NSCLC, and is expanded to include recommendations on SCLC and mesothelioma. The Expert Panel drew on the published literature as well as their clinical experience to develop recommendations for healthcare professionals on these important aspects of immunotherapeutic treatment for lung cancer and mesothelioma, including diagnostic testing, treatment planning, immune-related adverse events, and patient QOL considerations. The evidence- and consensus-based recommendations in this CPG are intended to give guidance to cancer care providers using immunotherapy to treat patients with lung cancer or mesothelioma.

Keywords: clinical trials as topic; guidelines as topic; immunotherapy; lung neoplasms.

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Conflict of interest statement

Competing interests: CA—Consulting fees: AstraZeneca, Celgene, Eli Lilly, Genetech, Merck. SJA—Advisory board: Bristol Myers Squibb, Celsius, Merck, Samyang Biopharma, AstraZeneca/Medimmune; Consultant: Bristol Myers Squibb, Celsius, Merck, Samyang Biopharma, AstraZeneca/Medimmune, CBMG, Memgen, RAPT, Venn, Achilles Therapeutics, GlaxoSmithKline, Amgen; Scientific advisory board: CBMG, Memgen, RAPT, Venn, Achilles Therapeutics, GlaxoSmithKline, Amgen. MD—Speaker bureaus: Genentech, Merck, Bristol Myers Squibb and AstraZeneca (all have been discontinued as of November 2019). SMD—Scientific advisory boards: Johnson & Johnson Scientific, T-Cure Bioscience, LungLife AI, Early Diagnostics; Contracted research: Jansen. PMF—Consulting fees: Amgen, AstraZeneca, Bristol Myers Squibb, Iteos, Novartis, Janssen; Contracted research: AstraZeneca, Bristol Myers Squibb, Kyowa, Novartis; DSMB: Polaris, Flame. EBG—Consulting fees: ABL-Bio, Boehringer Ingelheim, Bristol Myers Squibb, Dracen, EMD Serono, Eisai, GlaxoSmithKline, Merck, Novartis; Contracted research: AstraZeneca, Bristol Myers Squibb, Dynavax, EMD Serono, Eli Lilly, Genentech, Merck, Iovance Biotherapeutics, Mirati Therapeutics, Neon, Novartis. SBG—Consulting fees: AstraZeneca, Blueprint Medicine, Bristol Myers Squibb, Boehringer Ingelheim, Genentech, Sanofi Genzyme, Daiichi Sankyo, Regeneron, Takeda, Janssen; Contracted research: AstraZeneca, Boehringer Ingelheim. RG—Consulting fee: Achilles, GenePlus, Inivata, Roche. RH—Contracted research: My institution receives funds for conducting clinical trials from Bayer and TCR2 under a cooperative research and development agreement with NCI. MDH—Consulting fees: Merck, Bristol Myers Squibb, AstraZeneca, Genentech/Roche, Nektar, Syndax, Mirati, Shattuck Labs, Immunai, Blueprint Medicines, Achilles, Arcus; Contracted research: Bristol Myers Squibb; IP rights: A patent filed by his institution related to the use of tumor mutation burden to predict response to immunotherapy (PCT/US2015/062208), which has received licensing fees from PGDx; Ownership interest: Arcus, Shattuck Labs, Immunai. RSH—Consulting fees: AbbVie Pharmaceuticals, ARMO Biosciences, AstraZeneca, Bayer HealthCare Pharmaceuticals, Bolt Biotherapeutics, Bristol Myers Squibb, Candel Therapeutics, Cybrexa Therapeutics, eFFECTOR Therapeutics, Eli Lilly and Company, EMD Serono, Foundation Medicine, Genentech/Roche, Genmab, Gilead, Halozyme Therapeutics, Heat Biologic, I-Mab Biopharma, Immunocore, Infinity Pharmaceuticals, Loxo Oncology, Merck and Company; Mirati Therapeutics, Nektar, Neon Therapeutics, NextCure, Novartis, Ocean Biomedical, Oncternal Therapeutics, Pfizer, Ribbon Therapeutics, Ventana Medical Systems, Sanofi, Seattle Genetics, Shire PLC, Spectrum Pharmaceuticals, STCube Pharmaceuticals, Symphogen, Takeda, Tesaro, Tocagen, WindMIL Therapeutics, Xencor; Contracted research: AstraZeneca, Eli Lilly and Company, Genentech/Roche, Merck and Company; Board member (non-executive/independent): Immunocore Holdings Limited, Junshi Pharmaceuticals. FRH—Consulting fees: Merck, Bristol Myers Squibb, Genentech/Roche, Lilly/Loxo, Daiichi, Novartis, AstraZeneca, Boehringer Ingelheim, OncoCyte, Amgen, Sanofi/Regeneron; Contracted research through University of Colorado: Amgen, AbbVie, Biodesix, Rain Therapeutics, Aurora Oncology, Mersana; IP rights through University of Colorado: EGFR protein and EGFR Gene Copy Number as Predictive Biomarker for EGFR Therapy. MLJ—Consulting fees – all payments made to my institution: Achilles Therapeutics, Amgen, AstraZeneca, Atreca, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, EMD Serono, G1 Therapeutics, Roche/Genentech, GlaxoSmithKline, Gritstone, Incyte, Janssen, Lilly, Merck, Mirati, Novartis, Pfizer, Sanofi-Aventis, WindMIL Therapeutics; Contracted research – all payments made to my institution: AbbVie, Adaptimmune, Amgen, Apexigen, Array Biopharma, AstraZeneca, Atreca, BeiGene, BerGenBio, Boehringer Ingelheim, Calithera, Checkpoint Therapeutics, Corvus Pharmaceuticals, CytomX, Daiichi Sankyo, Lilly, EMD Serono, Roche/Genentech, Genmab, Genocea, GlaxoSmithKline, Gritstone Oncology, Guardant Health, Hengrui Therapeutics, Immunocore, Incyte, Janssen, Jounce, Mirati, Neovia Oncology, Novartis, Pfizer, Regeneron, Sanofi, Shattuck Labs, Syndax, Takeda, Tarveda, University of Michigan, WindMIL Therapeutics, TCR2 Therapeutics, Arcus, Ribon, Rubius Therapeutics, Tmunity Therapeutics, Seven and Eight Biosciences, Foundation Medicine; Partner consulting Fees: Otsuka. DM—Consulting fees: Gilead, G1 Therapeutics, AbbVie. JWN—Grants and personal fees: Takeda (during the conduct of the study), AstraZeneca; Grants (non-financial support): Genentech/Roche, Exelixis, Jounce Therapeutics, Eli Lilly and Company, Calithera Biosciences, Amgen, Iovance Biotherapeutics, Blueprint Pharmaceuticals, Regeneron Pharmaceuticals, Natera; Grants and non-financial support: Merck, Novartis, Boehringer Ingelheim, Nektar Therapeutics, Adaptimmune, GSK, Janssen, AbbVie. JDP—Consulting fees: AstraZeneca, AbbVie, Takeda; Contracted research: Bristol Myers Squibb, Takeda, RAIN. DLR—Consulting fees: AstraZeneca, Agendia, Amgen, BMS, Cell Signaling Technology, Cepheid, Danaher, Daiichi Sankyo, Genoptix/Novartis, GSK, Konica Minolta, Merck, NanoString, PAIGE.AI, Perkin Elmer, Roche, Sanofi, Ventana and Ultivue; Laboratory support: Amgen, Cepheid, NavigateBP, NextCure, and Konica Minolta. SS—Gift cards: Healthcasts-Syneos, ZOOM RX Surveys, Schlesinger Group, Impact Rx; Monetary compensation: Global M3. LHS—Contracted research: Merck, Bristol Myers Squibb, Regeneron. BS—Consulting fees: Bristol Myers Squibb. SITC staff: SMW—Shares owned: Pacific Biosciences, Editas Medicine; AK, LL, CG--Nothing to disclose

Figures

**Figure 1**
Algorithm for the treatment of advanced NSCLC based on the evidence- and consensus-based recommendations of the SITC Lung Cancer and Mesothelioma Clinical Practice Guideline Expert Panel. In all cases, chemotherapy selection should be guided by histology. Whenever possible, patients should be offered participation in clinical trials. *See the Contraindicated patient populations section for discussion of immunotherapy in special patient populations. †Comprehensive next-generation sequencing (NGS) is recommended for molecular testing. If NGS is not available, tumor tissue should be tested for molecular driver genetic alterations. ‡For PD-L1 expression assessment, the 22C3, 28–8, and SP263 assays are interchangeable. The SP142 assay is not interchangeable and does not perform equivalently to the other assays listed. FDA, US Food and Drug Administration; ICI, immune checkpoint inhibitor; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; SITC, Society for Immunotherapy of Cancer; TKI, tyrosine kinase inhibitor; TPS, tumor proportion score.

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Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lung cancer and mesothelioma

Affiliations

Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lung cancer and mesothelioma

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

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Full Text Sources

Medical