Real-World CAR-T Study in Older Patients With R/R DLBCL

During a joint oral podium presentation, results were shared from one of the largest real-world analyses of patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) receiving Chimeric Antigen Receptor T-cell (CAR-T) therapy. The presentation occurred at the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans.

This blog summarizes the study design, outcomes, and potential for impact.

Study design

Prior to this study, there was little real-world evidence regarding survival outcomes from Chimeric antigen receptor (CAR) T-cell therapy for elderly patients with diffuse large B-cell lymphoma (DLBCL). Inovalon’s unparalleled primary source dataset made it possible to identify a distinct patient population from which real-world evidence is scarce, and within a disease state in which advanced research is challenging. This study aimed to examine the real-world outcomes and the economic impact of this therapy.

Patients included in this study met the following criteria:

• • 65 years of age or older
  • Minimum of one inpatient or two outpatient claims with a diagnosis of DLBCL
  • Received a diagnosis between 4/1/2016 and 12/1/2020
  • Had at least one claim for the administration of CAR T-cell therapy between 1/1/2018 and 12/31/2020
  • No previous clinical trial participation

Study results

Compared to outcomes from phase 2 studies, DLBCL patients receiving CAR-T therapy presented favorable event free survival (EFS). However, only 13% of older patients (age 75 or more) with DLBCL were prescribed CAR-T therapy. For these patients, the EFS rate was less favorable with a median overall survival (OS) of 17.1 months.

The study revealed costs of CAR-T were substantial, and coupled with EFS rates, indicate an unmet need for patients 75 years or older.

“This study is a compelling demonstration of the positive impact real-world data is having on the ability to accelerate research on treatment outcomes, even in the most challenging scenarios.”

– Joseph Tkacz, Senior Director, Health Economics and Outcomes Research, Inovalon

Potential for impact of CAR-T cell therapy

Older patients account for more than half of the DLBCL population, and 30% of them are over 75 years of age. This is a critical subpopulation that has historically been under-represented in CAR-T trials.

To date, there has been little real-world evidence on this type of therapy within this population. Increased awareness of the costs and potential outcomes associated with CAR-T therapy is significant for both providers and patients, as it provides additional context when reviewing treatment options. Additionally, for life sciences companies, real-world evidence provides accurate treatment valuation and allows them to earn fair reimbursement from payers.

This is also the largest study of DLBCL patients prescribed CAR T-cell therapy thus far using Medicare claims data. The study utilized a 100% Medicare Fee-For-Service (FFS) database.

Real-world data for research

Access to the Medicare FFS database made this study – and its important findings – possible. This is just one example of the immense potential for value when expert healthcare analysts apply real-world data to address key questions.

Inovalon’s Data Solutions team offers our extensive subject matter expertise to help healthcare organizations conduct studies such as this. Combined with our industry-leading primary source dataset, we can help unlock the key to many answers regarding unique subpopulations, treatment validation, and more.

To view this study and other real-world evidence, visit our Research and Publications page.

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