IL-6 modulation for COVID-19: the right patients at the right time?
This article is part of the special JITC series: COVID-19 and Cancer Immunotherapy
IL-6 modulation for COVID-19: the right patients at the right time?
This article is part of the special JITC series: COVID-19 and Cancer Immunotherapy
Severity of COVID-19 in patients with lung cancer: evidence and challenges
This article is part of the special JITC series: COVID-19 and Cancer Immunotherapy
Interrogation of the cellular immunome of cancer patients with regard to the COVID-19 pandemic
This article is part of the special JITC series: COVID-19 and Cancer Immunotherapy
Perspectives on COVID-19 and cancer immunotherapy: a review series
This article is part of the special JITC series: COVID-19 and Cancer Immunotherapy
Imaging endpoints for clinical trial use: a RECIST perspective
This article is part of the special JITC series: Imaging and Immunotherapy
Artificial intelligence and radiomics: fundamentals, applications, and challenges in immunotherapy
This article is part of the special JITC series: Imaging and Immunotherapy
Imaging cellular immunotherapies and immune cell biomarkers: from preclinical studies to patients
This article is part of the special JITC series: Imaging and Immunotherapy
MRI techniques for immunotherapy monitoring
This article is part of the special JITC series: Imaging and Immunotherapy
Molecular imaging to support cancer immunotherapy
This article is part of the special JITC series: Imaging and Immunotherapy
NIR fluorescence imaging and treatment for cancer immunotherapy
This article is part of the special JITC series: Imaging and Immunotherapy
Imaging approaches and radiomics: toward a new era of ultraprecision radioimmunotherapy?
This article is part of the special JITC series: Imaging and Immunotherapy
iRECIST and atypical patterns of response to immuno-oncology drugs
This article is part of the special JITC series: Imaging and Immunotherapy
Perspectives on imaging and immunotherapy: a review series
This article is part of the special JITC series: Imaging and Immunotherapy
SITC 37th Annual Meeting (SITC 2022) Abstracts
test
Liquid biopsies coming of age: biology, emerging technologies, and clinical translation- An introduction to the JITC expert opinion special review series on liquid biopsies
This article is part of the special JITC series: Liquid Biopsies Coming of Age: Biology, Emerging Technologies, and Clinical Translation
Cell-free DNA approaches for cancer early detection and interception
This review has a companion letter: Brave new world of cfDNA-omics for early cancer detection
This article is part of the special JITC series: Liquid Biopsies Coming of Age: Biology, Emerging Technologies, and Clinical Translation
Brave new world of cfDNA-omics for early cancer detection
This viewpoint letter refers to a companion review: [Cell-free DNA approaches for cancer early detection and interception] (https://jitc.bmj.com/content/11/9/e006013)
This article is part of the special JITC series: Liquid Biopsies Coming of Age: Biology, Emerging Technologies, and Clinical Translation
table 5
Update 8-1-2023
The mUC treatment algorithm has been updated based on the label change for pembrolizumab, the voluntary withdrawal of the atezolizumab indication, and the approval of pembrolizumab plus enfortumab vedotin for the treatment of patients with advanced mUC.
Challenges in the implementation of ultrasensitive liquid biopsy approaches in precision oncology
This is a companion letter corresponding with the review: Genomic approaches to cancer and minimal residual disease detection using circulating tumor DNA
This article is part of the special JITC series: Liquid Biopsies Coming of Age: Biology, Emerging Technologies, and Clinical Translation
Genomic approaches to cancer and minimal residual disease detection using circulating tumor DNA
This review has a companion letter: Challenges in the implementation of ultrasensitive liquid biopsy approaches in precision oncology
This article is part of the special JITC series: Liquid Biopsies Coming of Age: Biology, Emerging Technologies, and Clinical Translation
Liquid biopsies, are we ready for prime time?
This is a companion letter corresponding with the review: Regulatory implications of ctDNA in immuno-oncology for solid tumors
This article is part of the special JITC series: Liquid Biopsies Coming of Age: Biology, Emerging Technologies, and Clinical Translation
Regulatory implications of ctDNA in immuno-oncology for solid tumors
This review has a companion letter: Liquid biopsies, are we ready for prime time?
This article is part of the special JITC series: Liquid Biopsies Coming of Age: Biology, Emerging Technologies, and Clinical Translation
Liquid biopsy approaches to capture tumor evolution and clinical outcomes during cancer immunotherapy
This review has a companion letter: Next-generation ctDNA-driven clinical trials in precision immuno-oncology
This article is part of the special JITC series: Liquid Biopsies Coming of Age: Biology, Emerging Technologies, and Clinical Translation
Next-generation ctDNA-driven clinical trials in precision immuno-oncology
This is a companion letter corresponding with the review: Liquid biopsy approaches to capture tumor evolution and clinical outcomes during cancer immunotherapy
This article is part of the special JITC series: Liquid Biopsies Coming of Age: Biology, Emerging Technologies, and Clinical Translation
Comments on roles of circulating tumor cells in the metastatic cascade and tumor immune escape: biology and clinical translation
This is a companion letter corresponding with the review: Crucial roles of circulating tumor cells in the metastatic cascade and tumor immune escape: biology and clinical translation
This article is part of the special JITC series: Liquid Biopsies Coming of Age: Biology, Emerging Technologies, and Clinical Translation
Crucial roles of circulating tumor cells in the metastatic cascade and tumor immune escape: biology and clinical translation
This review has a companion letter: Comments on roles of circulating tumor cells in the metastatic cascade and tumor immune escape: biology and clinical translation
This article is part of the special JITC series: Liquid Biopsies Coming of Age: Biology, Emerging Technologies, and Clinical Translation
The society for immunotherapy of cancer consensus statement on immunotherapy for the treatment of advanced renal cell carcinoma (RCC)
SITC continuously evaluates the field for emerging data and new FDA approvals. Updates to the recommendations, tables, treatment algorithms, and/or guideline text in this publication are made with the approval of the SITC Urothelial Cancer Immunotherapy Guideline Expert Panel. More information on the SITC Guidelines can be found at sitcancer.org/guidelines.
Update 8-17-22
Based on advances in the field, including the following three FDA approvals and ongoing trials, the RCC CPG has been updated throughout the entire manuscript:
(1) Pembrolizumab for the adjuvant treatment of RCC: In November of 2021, the FDA approved pembrolizumab (anti-PD-1) for the adjuvant treatment of resected RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Reference: FDA approves pembrolizumab for adjuvant treatment of renal cell carcinoma FDA press release
(2) Pembrolizumab plus lenvatinib for the treatment of advanced RCC: In August of 2021, the FDA approved pembrolizumab in combination with lenvatinib (a VEGF receptor tyrosine kinase inhibitor; TKI) for the first-line treatment of patients with advanced RCC (aRCC).
Reference: FDA approves lenvatinib plus pembrolizumab for advanced renal cell carcinoma FDA press release
(3) Nivolumab plus cabozantinib for the treatment of advanced RCC: In January of 2021, the FDA approved nivolumab (anti-PD-1) in combination with cabozantinib (a VEGF receptor TKI) for the first-line treatment of patients with aRCC.
Reference: FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma FDA press release
arthritic symptoms
Update 8-17-22
Upon survey of the Expert Panel following the FDA approvals for use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, the following text was added:
For first-line treatment of patients with unresectable, metastatic clear cell RCC and a remote history of a non-life threatening autoimmune condition, irrespective of IMDC risk status, the Expert Panel recommends the following: pembrolizumab plus lenvatinib (23%), nivolumab plus ipilimumuab (23%), nivolumab plus cabozantinib (15%), appropriate anti-VEGF TKI monotherapy (15%), pembrolizumab plus axitinib (15%), or anti-PD-1 monotherapy (8%).
The subcommittee was undecided between treatments with an IO-based monotherapy versus a TKI for first-line treatment of patients with chromophobe RCC.
Update 8-17-22
Upon survey of the Expert Panel following the FDA approvals for the use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, this text was modified as follows:
For first-line treatment for patients with chromophobe RCC, the Expert Panel recommends the following: VEGF TKI plus ICI (40%: lenvatinib plus pembrolizumab [3 Expert Panel members], cabozantinib plus nivolumab [2 Expert Panel members], axitinib plus pembrolizumab [1 Expert Panel member]), lenvatinib plus everoliums (40%), everolimus (7%), or everolimus plus bevacizumab (7%).
The subcommittee recommend IO-based therapy for first-line treatment of patients with papillary and unclassified RCC, specifically single-agent anti-PD-1 for either subtype with the additional treatment possibilities of ipilimumab/nivolumab combination therapy for the latter.
Update 8-17-22
Upon survey of the Expert Panel following the FDA approvals for use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, this text was modified as follows:
For first-line treatment for patients with papillary RCC, the Expert Panel recommends the following: nivolumab plus cabozantinib (87%), mivolumab plus ipilimumab (7%), or anti-PD1 monotherapy (7%).
For first-line treatment for patients with undifferentiated RCC, the Expert Panel recommends the following: VEGF TKI plus ICI (53%: nivolumab plus cabozantinib [4 Expert Panel members], pembrolizumab plus lenvatinib [4 Expert Panel members]), or nivolumab plus ipilimumab (47%).
immunotherapy agents.
Update 8-17-22
Upon survey of the Expert Panel following the FDA approval for use of adjuvant pembrolizumab for RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, the following text was added:
For patients with nccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of isolated soft tissue metastases, 80% of the Expert Panel disagreed that adjuvant pembrolizumab is recommended (presuming that the patient has an acceptable performance status and no contraindications to checkpoint inhibitor therapy).
As for first-line treatment for patients with sarcomatoid RCC irrespective of IMDC risk factors, 83% of the subcommittee recommend nivolumab plus ipilimumab combination immunotherapy while 11% recommend treatment with axitinib/pembrolizumab and 6% would recommend axitinib/avelumab.
Update 8-17-22
Upon survey of the Expert Panel following the FDA approvals for use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, the following text was modified as follows:
For first-line treatment for patients with sarcomatoid RCC irrespective of the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk factors, the Expert Panel recommends: nivolumab plus ipilimumab (80%), pembrolizumab plus axitinib (13%), or nivolumab plus cabozantinib (7%).
In patients whose disease has progressed at or beyond 6 months following adjuvant anti-PD-1/PD-L1 monotherapy, the subcommittee was split (47%/47%) as to their recommendation of an IO/IO or IO/TKI regimen following adjuvant immunotherapy, specifically nivolumab/ipilimumab vs. axitinib/pembrolizumab.
Update 8-17-22
Upon survey of the Expert Panel following the FDA approval for use of adjuvant pembrolizumab for RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, this text was modified as follows:
For patients who develop unresectable metastatic RCC at or beyond 6 months following adjuvant pembrolizumab (presuming that the patient has an acceptable performance status and no contraindications to checkpoint inhibitor therapy or any TKI), the Expert panel recommends the following: ICI plus TKI (47%), cabozantinib plus nivolumab (2 Expert Panel members), lenvatinib plus pembrolizumab (3 Expert Panel members), nivolumab plus ipilimumab (53%).
67% of the subcommittee would recommend nivolumab/ipilimumab to a patient with aRCC who received prior adjuvant IO therapy within the last 6 months (33% of the subcommittee would choose not to recommend nivolumab/ipilimumab in this setting).
Update 8-17-22
Upon survey of the Expert Panel following the FDA approval for use of adjuvant pembrolizumab for RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, this text was modified as follows:
For patients who develop unresectable metastatic RCC during or within 6 months of receiving adjuvant pembrolizumab (presuming that the patient has an acceptable performance status and no contraindications to checkpoint inhibitor therapy or any TKI), the Expert panel recommends the following: nivolumab plus ipilimumab (33%), single agent TKI (27%), ICI plus TKI (20%), pembrolizumab plus lenvatinib (2 Expert Panel members), nivolumab plus cabozantinib (1 Expert Panel member), lenvatinib plus everolimus (7%), or other/ unsure of what would be best in this setting (7%).
SOC in the adjuvant setting (ongoing trials)
Update 8-17-22
Subheader changed to the following: SOC in adjuvant setting (including ongoing trials)
With
Update 8-17-22
Upon survey of the Expert Panel following the FDA approval for use of adjuvant pembrolizumab for RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, the following text was added:
For patients with resected ccRCC and no contraindications to immunotherapy, this expert panel recommends adjuvant pembrolizumab for: all patients meeting inclusion criteria for KEYNOTE-564 (60%), only higher risk patients eg, T4 or N+ (27%), or no patients until there is a statistically significant OS advantage (13%).
subcommittee also
Update 8-17-22
Upon survey of the Expert Panel following the FDA approvals for use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, the following text was added:
For a patient who has progressed after lenvatinib plus pembrolizumab combination therapy, the Expert Panel recommends the following: <br /> cabozantinib (73%), ipilimumab plus nivolumab (13%), lenvatinib plus everolimus (7%), cabozantinib plus nivolumab (7%).
Specifically, the
Update 8-17-22
Upon survey of the Expert Panel following the FDA approvals for use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, the following text was added:
For a patient who has progressed after cabozantinib plus nivolumab combination therapy, the Expert Panel recommends the following: lenvatinib plus everolimus (67%), nivolumab plus ipilimumab (13%), tivozanib (7%), everolimus (7%), or lenvatinib + pembrolizumab (7%).
In treating patients with disease progression after IO/VEGFR TKI combination therapy (either axitinib/pembrolizumab or axitinib/avelumab), the subcommittee consensus was to recommend treatment with cabozantinib (83%), while 11% recommended nivolumab/ipilimumab and 6% recommended lenvantinib/everolimus.
Update 8-17-22
Upon survey of the Expert Panel following the FDA approvals for use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, this text was modified as follows:
For a patient who has progressed after axitinib plus pembrolizumab combination therapy, the Expert Panel recommends the following: cabozantinib (67%), ipilimumab plus nivolumab (13%), lenvatinib plus everolimus (7%), cabozantinib plus nivolumab (7%), or lenvatinib plus pembrolizumab (7%).
are unknown.
Update 8-17-22
Upon survey of the Expert Panel following the FDA approvals for use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, the following text was added:
For first-line treatment of patients with unresectable, metastatic VHL-associated ccRCC, the Expert Panel recommends the following: belzutifan (53%), nivolumab plus ipilimumab (27%), or cabozantinib plus nivolumab (20%).
In determining when to give a treatment-naïve patient IO monotherapy over an IO-based doublet therapy, the subcommittee recommend IO monotherapy for patients with a history of autoimmune disease that is not potentially life threatening and is not currently on immunosuppressive agents (56%), elderly patients over 80 years of age (50%), patients with a history of vascular disease such as stroke, recent ischemic cardiac disease without CABG (39%), patients with poor performance status (28%), patients with IMDC favorable risk (6%), and patients with liver metastases with mildly increased LFTs (6%). 17% of subcommittee members would never recommend IO monotherapy over an IO-based doublet therapy.
Update 8-17-22
Upon survey of the Expert Panel following the FDA approvals for use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, the following text was added:
For first-line treatment of patients with unresectable, metastatic clear cell RCC and a remote history of a non-life threatening autoimmune condition, irrespective of IMDC risk status, the Expert Panel recommends the following: pembrolizumab plus lenvatinib (23%), nivolumab plus ipilimumuab (23%), nivolumab plus cabozantinib (15%), appropriate anti-VEGF TKI monotherapy (15%), pembrolizumab plus axitinib (15%), or anti-PD-1 monotherapy (8%).
Anti-PD-1
Update 8-17-22
Upon survey of the Expert Panel following the FDA approvals for use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, the following text was added:
For a treatment naïve, ECOG ≥ 1 ccRCC patient with “poor” risk per IMDC, who is determined to need systemic therapy and has no contraindication to receiving either an IO or an anti-VEGF therapy, the Expert Panel recommends the following: nivolumab plus ipilimumab (47%), VEGF TKI plus checkpoint inhibitor combination (23%: pembrolizumab plus lenvatinib [17%], pembrolizumab plus axitinib [11%], nivolumab plus cabozantinib [11%], pembrolizumab or nivolumab monotherapy [6%]).
For a treatment naïve, ECOG 0 ccRCC patient with “favorable” risk per IMDC, who is determined to need systemic therapy and has no contraindication to receiving either an IO or an anti-VEGF therapy, 50% of the subcommittee recommend treatment with axitinib/pembrolizumab, 28% recommend treatment with nivolumab/ipilimumab, 11% recommend TKI monotherapy, and 6% recommend treatment with either axitinib/avelumab or HDIL-2.
Update 8-17-22
Upon survey of the Expert Panel following the FDA approvals for use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, this text was modified as follows:
For a treatment naïve, ECOG 0 ccRCC patient with “favorable” risk per IMDC, who is determined to need systemic therapy and has no contraindication to receiving either an IO or anti-VEGF therapy, the Expert Panel recommends the following: TKI plus anti-PD1 (60%), nivolumab plus ipilimumab (33%), or anti-PD1 monotherapy (7%).
Fig. 1 Immunotherapy treatment algorithm for patients with advanced renal cell carcinoma
How should adjuvant therapy and related failures be managed within an IO-related treatment paradigm for patients with accRCC?
(1) Pembrolizumab for the adjuvant treatment of RCC: In November of 2021, the FDA approved pembrolizumab (anti-PD-1) for the adjuvant treatment of resected RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. - This approval was based on a statistically significant improvement in DFS demonstrated at a prespecified interim analysis of the KEYNOTE-564 study, with 109 (22%) events in the pembrolizumab arm and 151 (30%) events in the placebo (HR 0.68; 95% CI: 0.53, 0.87; p=0.0010). The November of 2021 FDA approval of pembrolizumab for the adjuvant treatment of resected RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, was based on data from the KEYNOTE-564 study. This study demonstrated a statistically significant improvement in DFS at a pre-specified interim analysis, with 109 (22%) events in the pembrolizumab arm and 151 (30%) events in the placebo (HR 0.68; 95% CI: 0.53, 0.87; p=0.0010).
For a treatment naïve, ECOG 0 ccRCC patient with “intermediate/poor” risk per IMDC, who is determined to need systemic therapy and has no contraindication to receiving either an IO or an anti-VEGF therapy, 78% recommend treatment with nivolumab/ipilimumab, 17% of the subcommittee recommend treatment with axitinib/pembrolizumab, and 6% recommend ICI monotherapy.
Upon survey of the Expert Panel following the FDA approvals for use of first-line pembrolizumab plus lenvatinib or nivolumab plus cabozantinib for aRCC, this text was modified as follows:
For a treatment naïve, ECOG 0 ccRCC patient with “intermediate/poor” risk per IMDC, who is determined to need systemic therapy and has no contraindication to receiving either an IO or an anti-VEGF therapy, the Expert Panel recommends the following: nivolumab plus ipilimumab (80%), anti-PD1 plus TKI (20%, with 53% preferring nivolumab plus cabozantinib and 40% preferring pembrolizumab plus lenvatinib), or other (7% preferring lenvatinib + everolimus).
How should checkpoint inhibitors be integrated into the first-line treatment of advanced clear cell renal cell carcinoma (accRCC)?
The August 2021 FDA approval of pembrolizumab in combination with lenvatinib for the first-line treatment of patients with aRCC was based on a statistically significant improvement in PFS and OS in CLEAR (Study 307/ KEYNOTE-581). Patients receiving pembrolizumab plus lenvatinib had a median PFS of 23.9 months versus 9.2 months for those receiving sunitinib (HR 0.39; 95% CI: 0.32 to 0.49; p<0.0001). Median OS was not reached in either arm (HR 0.66; 95% CI: 0.49 to 0.88; p=0.0049).
The January 2021 FDA approval of nivolumab in combination with cabozantinib for the first-line treatment of patients with aRCC was based on a statistically significant improvement in PFS, OS, and ORR in the CHECKMATE-9ER study. Patients receiving nivolumab plus cabozantinib had a median PFS of 16.6 months versus 8.3 months for those receiving sunitinib (HR 0.51; 95% CI: 0.41, 0.64). Median OS was not reached in either arm (HR 0.60; 95% CI: 0.40 to 0.89). ORR was 55.7% versus 27.1% in the nivolumab plus cabozantinib and sunitinib arms, respectively.
Patients with hypophysitis should receive replacement hydrocortisone at 10–12 mg/m2/day.
Update 8-27-2021
To add additional guidance on the management of patients with ICI-related hypophysitis and severe compressive symptoms, this recommendation was updated, as noted below:
Consider performing a baseline electrocardiogram (EKG) on patients deemed at a higher risk for myocarditis (eg, cardiac comorbidities, diabetes mellitus, anti-PD-(L)1 with anti-CTLA-4 ICI combination therapy, etc). Baseline troponin testing may also be considered to provide information for evaluating potential future cardiac toxicity.
Update October 2022
The recommendation on baseline troponin testing has been updated, as noted below:
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events
SITC continuously evaluates the field for emerging data and new FDA approvals. Updates to the recommendations, tables, treatment algorithms, and/or guideline text in this publication are made with the approval of the SITC Cancer Immunotherapy Guideline Expert Panel. More information on the SITC Guidelines can be found at sitcancer.org/guidelines
Update October 2022
In response to recent data regarding increased risk for MACE in patients with RCC receiving ICI + VEGF TKI therapy, the ICI-related Adverse Events Guideline was updated in the following location: * General Expert Panel Recommendations
Update 8-7-2021
To add additional guidance on the management of patients with ICI-related hypophysitis and severe compressive symptoms, the ICI-related Adverse Events CPG was updated in the following location: * Endocrine Toxicity Expert Panel Recommendations
CAR T cells
Update 4-9-2021
Information on idecabtagene vicleucel approval data and indication has been added, as noted below:
Panel recommendations
Update 8-5-2020
A recommendation has been added, as noted below:
During belantamab mafodotin treatment specifically, therapy can be restarted once keratopathy or other AEs (such as cytopenias) have resolved to grade 1 or less. Dose reduction from 3.4 to 2.5 mg/kg may be considered. Further dose reductions to 1.9 mg/kg may be done if significant toxicity recurs.
Update 8-5-2020
The following recommendation has been removed:
Management of moderate-to-severe corneal toxicity includes holding therapy until improvement of symptoms to grade 1 or less and improvement of corneal changes is confirmed by ophthalmological examination, then restarting with a one level dose reduction.
Update - 8-5-2020
A recommendation was updated, as noted below:
Management of corneal toxicity includes use of preservative-free lubricant eye drops as needed for symptoms of dryness, blurry vision or photophobia.
Update 8-5-2020
A recommendation was updated, as noted below:
Monitoring in the initial studies included weekly complete blood counts and complete metabolic panels. After the first few cycles or after blood counts normalize, testing can be reduced to occur every treatment cycle.
Update 8-5-2020
A recommendation was updated, as noted below:
Panel recommendations
Update 8-5-2020
An additional recommendation was added, as noted below:
In 2017, belantamab mafodotin was awarded Breakthrough Therapy designation from the FDA and PRIME designation from the EMA. Belantamab mafodotin is currently in clinical development in patients with RRMM and other advanced hematological malignancies expressing BCMA but is not yet approved for use.
Update 8-5-2020
The approval status and information regarding Belantamab mafadotin has been updated, as noted below:
Introduction
Update August 2022
Text has been added to the introduction to include updated information on pembrolizumab and dostarlimab tissue-agnostic approvals, as noted below:
The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of prostate carcinoma
SITC continuously evaluates the field for emerging data and new FDA approvals. Updates to the recommendations, tables, treatment algorithms, and/or guideline text in this publication are made with the approval of the SITC Prostate Cancer Immunotherapy Guideline Expert Panel. More information on the SITC Guidelines can be found at sitcancer.org/guidelines.
Update August 2022
Based on the tissue agnostic approvals for pembrolizumab for the treatment of TMB-H and MSI-H/dMMR solid tumors and dostarlimab for the treatment of dMMR solid tumors, and their approved companion diagnostics, the Prostate Cancer CPG has been updated in the following location: - Introduction
References: Pembrolizumab (KEYTRUDA) TMB-H tissue-agnostic approval
Pembrolizumab (KEYTRUDA) MSI-H/dMMR tissue-agnostic approval
Dostarlimab (JEMPERLI) dMMR tissue-agnostic approval
Update 8-24-22
Based on new approvals of immunotherapy agents for the treatment of prostate cancer and new data that has been published since its original publication, the Prostate CPG was updated in the following locations: - Figure 1 - Prostate Cancer Treatment Algorithm
The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of multiple myeloma
SITC continuously evaluates the field for emerging data and new FDA approvals. Updates to the recommendations, tables, treatment algorithms, and/or guideline text in this publication are made with the approval of the SITC Multiple Myeloma Cancer Immunotherapy Guideline Expert Panel. More information on the SITC Guidelines can be found at sitcancer.org/guidelines.
Update 2-1-2022
Based on the FDA approval of daratumumab in combination with carfilzomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy on November 30, 2021, the Multiple Myeloma CPG has been updated in the following locations: * Monoclonal Antibodies Expert Panel Recommendations * Multiple Myeloma Key Monoclonal Antibody Therapies Trials
Update 4-9-2021
Based on the approval of idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, the Multiple Myeloma CPG has been updated in the following locations: * Background * CAR T cell Therapies
Reference: Idecabtagene vicleucel (ABECMA) FDA press release
Based on the approval of isatuximab-irfc in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, the Multiple Myeloma CPG has been updated in the following locations: * Monoclonal Antibody Therapies * Multiple Myeloma Key Monoclonal Antibody Therapies Trials
Reference: Isatuximab-irfc (SARCLISA) FDA press release
Update 8-5-2020
Based on the accelerated approval of belantamab mafodotin-blmf for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent, the Multiple Myeloma CPG was updated in the following locations: * Antibody-Drug Conjugates * Background
Reference: Belantamab mafodotin-blmf (BLENREP) FDA press release