The landscape of CAR T‐cell therapy in the United States and China: A comparative analysis

e18541 Background: With increasing numbers of newly approved cancer immunotherapy regimens, research is needed to understand whether these costly treatments are equally used by all patients who could benefit from them. The aim of this systematic review was to identify variables linked to whether patients diagnosed with cancer were treated with checkpoint inhibitors and chimeric antigen receptor (CAR) T-cell therapy. Methods: Using the PICO (Patient, Intervention, Comparison, Outcome) framework, we conducted a systematic review searching Medline (New PubMed), Embase.com, and the Cochrane Library (Wiley) for papers published in English between January 1, 1997 and July 27, 2020. Inclusion criteria were: 1) primary, peer-reviewed research article; and 2) article reported variables associated with whether patients were treated with checkpoint inhibitors or CAR T-cell therapy. Seven coders independently reviewed titles, abstracts, full texts, and extracted data. The systematic review adhered to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Results: In total, 5958 titles and abstracts and 134 full texts were screened. Sixteen studies were included in final analyses. All were conducted in the United States using data from national databases (N = 15) or electronic medical records (N = 1). Eleven were cross-sectional, and 5 were cohort studies. Studies looked at melanoma (N = 10), non-small cell lung cancer (N = 3), renal cell carcinoma (N = 2), colorectal cancer (N = 1), prostate cancer (N = 1), and hepatobiliary cancer (N = 1). Studies looked at nivolumab (N = 1), pembrolizumab (N = 1), ipilimumab (N = 1), and sipuleucel-T, (N = 1), and 12 studies did not specify medication names. Treatment facility characteristics (N = 9), geographic location within the United States (N = 1), locale classification (N = 2), distance to treatment facility (N = 2), insurance type (N = 9), age (N = 7), race (N = 5), sex (N = 1), income (N = 4), neighborhood educational attainment (N = 2), comorbidities (N = 6), disease stage (N = 1), metastases (N = 3), clinical trial participation (N = 1), recency of diagnosis (N = 2), other treatments received (N = 3), and lesion characteristics (N = 1) were reported to be associated with whether patients were treated with checkpoint inhibitors or CAR T-cell therapy. Other studies found that insurance type (N = 1), race (N = 3), sex (N = 1), other treatments received (N = 1), and lesion characteristics (N = 1) were not associated with receiving checkpoint inhibitors or CAR T-cell therapy. Conclusions: Findings provide evidence of disparate access to checkpoint inhibitors and CAR T-cell therapy. More studies are necessary to thoroughly understand how the factors highlighted in our findings intersect to create and maintain disparities in cancer treatment. This level of information is necessary to create interventions that promote equitable access to novel cancer immunotherapies.

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Chimeric Antigen Receptor T Cell Therapy Pipeline at a Glance: A Retrospective and Systematic Analysis from Clinicaltrials.Gov

Blood ◽

10.1182/blood-2019-132273 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 5629-5629 ◽

Cited By ~ 2

Author(s):

Eider F Moreno Cortes ◽

Caleb K Stein ◽

Paula A Lengerke Diaz ◽

Cesar A Ramirez-Segura ◽

Januario E. Castro

Keyword(s):

Clinical Trials ◽

T Cells ◽

T Cell ◽

Cell Therapy ◽

The United States ◽

T Cell Therapy ◽

Car T Cells ◽

Car T Cell ◽

Car T Cell Therapy ◽

Car T

Background: Chimeric Antigen Receptor (CAR) T cell therapy is a promising cancer immunotherapy that is growing exponentially. The doubling time of medical knowledge in 2010 was 3.5 years, and the projection for 2020 is just 73 days. In the last five years, the number of PubMed publications on cancer applications of CAR T cells has tripled. Therefore, to remain updated in the field represents a challenge for patients, care providers and researchers. In this review we provide a focused summary of the currently ongoing clinical trials, with a comprehensive overview of advances in CAR T cell therapy, beyond CD19, emphasizing on antigenic targets, development phases, and leading sponsor pharmaceutical companies. Methods: We retrieved the available data from the national registry of clinical trials (clinicaltrials.gov) using the following keywords: "CAR T cell", "CAR T cell and cancer", "chimeric antigen receptor", "CAR T AND tumor antigen", 'CAR T cell antigens", "Tumor antigens targeted by CAR T cells", "engineered T cells", "modified T cell", "CAR T cells in Cancer", "CAR T cell therapy", "CAR T cell therapy AND Cancer" until December 31, 2018 and manually excluded the trials unrelated to CAR T-cell therapies on cancer, by reviewing the detailed information provided on the website as well as preliminary data published. Results: The analysis included 271 clinical trials posted on the clinicaltrials.gov website from the United States by the cut-off date. For efficacy analysis, we retrieved information from 52 trials, by NCT number on a PubMed search. The majority of CAR T clinical research is focused on hematological cancer (57%), followed by CNS 8%, GI 6%, Skin 5%, Genitourinary 4%, Breast 4%, Gynecologic 4%, Respiratory 3%, Sarcoma 2%, Mesothelioma 2% and others 5%. The most used target in CAR T cell therapy and the leaders in phase 3 trials are CD19 (42%) and BCMA (12%), followed by CD20, NY-ESO-1, Mesothelin, HER2, GD2, MAGE-A3 and CD30. An essential step in CAR T cell therapy development is the selection of the right antigen/target. Here, we provide an overview of the clinically relevant targets that are actively being using by clinical trials in the United States. For example, CD19 appears to be a leading target regarding CAR T cell therapy on cancer with 116 trials (42% of total CAR T cells trials) on going just in the United States with a significant increment in the previous years. Similarly, with BCMA is one of the targets with more phase 3 trials (Figure 1) with promising results on patients with Multiple Myeloma with and the objective response of 85%, CR 45%, and PFS of 11.8 months. Second-generation CARs with either CD28 or 4-1BB as costimulatory signaling domain are preferred, with 4-1BB being the most commonly chosen. Conclusions: Our findings show growing trends in the development of CAR T cell-based therapies, combination and possible retargeting therapies in the future for solid tumor and hematologic malignances; taking into account the amount of important information and the complexity of the database, we have developed this analysis to understand how to generate in the future a friendly platform for researchers and patients to have an detailed overview of the clinical trials in cellular therapies Disclosures No relevant conflicts of interest to declare.

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Health care resource utilization (HCRU) and total costs of care (TCOC) among patients (pts) with diffuse large B-cell lymphoma (DLBCL) treated with chimeric antigen receptor (CAR) T-cell therapies in the United States: An analysis of four claims databases.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.29_suppl.76 ◽

2020 ◽

Vol 38 (29_suppl) ◽

pp. 76-76

Author(s):

Scott J. Keating ◽

Tao Gu ◽

Monika Parisi Jun ◽

Corey Pelletier ◽

Ali McBride

Keyword(s):

Health Care ◽

T Cell ◽

Cell Therapy ◽

B Cell Lymphoma ◽

The United States ◽

T Cell Therapy ◽

Cell Therapies ◽

Car T Cell ◽

Car T Cell Therapy ◽

Car T

76 Background: Non-Hodgkin lymphoma comprises a heterogenous group of hematologic malignancies, including aggressive lymphomas such as DLBCL. Novel treatment modalities include CAR T cell therapies. Limited real-world data exist on HCRU and costs among pts treated with FDA-approved CAR T cell therapies. Methods: Pts with DLBCL treated with CAR T cell therapies were identified in 4 databases (IBM MarketScan, n = 60; Optum Clinformatics, n = 56; PharMetrics Plus, n = 75; and Humana, n = 14) from September 2017–H2 2019. Mean total, inpatient, outpatient, and pharmacy costs were calculated and adjusted to 2019 US dollars. HCRU and costs were stratified by adverse events (AEs) of interest—cytokine release syndrome (CRS) and neurological events (NEs)—identified through unvalidated “loose” and “strict” criteria. Results: A total of 205 pts were identified. Across databases, mean age ranged from 55.2–68.9 years, 63%−86% were male, and 88%−100% received CAR T cell therapy in the inpatient setting. In the 3 months after CAR+ T cell infusion, mean TCOC for all pts ranged from $353,642−$525,772 across databases (Table); mean TCOC were highest among pts who had CRS ($344,486−$730,224; strict CRS criteria). Mean inpatient length of stay (LOS) ranged from 17−21 days and was longer among pts who had CRS (18−23 days; n = 62) or NEs (20−24 days; n = 89) (strict CRS/NE criteria). Conclusions: HCRU and TCOC among pts with DLBCL treated with CAR T cell therapies were generally higher among pts who experienced CRS or NEs. Payors and health care systems may benefit from considering the total cost of CAR T cell therapy, including HCRU associated with treatment-emergent AEs. [Table: see text]

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