Expert: Unmet Need for Accessible, Effective, Tolerable Therapy for Older Patients With R/R DLBCL

Pharmacy Times® interviewed Joseph Tkacz, MS, senior director, Health Economics and Outcomes Research at Inovalon, on the podium presentation titled “Real-World Effectiveness and Economic Impact Associated with Chimeric Antigen Receptor [CAR] T-Cell Therapy Among Older Patients with Relapsed/Refractory [R/R] Diffuse Large B-Cell Lymphoma [DLBCL] in US” at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition.

With the development of CAR T-cell therapy, the treatment landscape of R/R DLBCL has changed significantly. Yet there remains a lack of real-world evidence demonstrating the survival outcomes of older patients with DLBCL who are treated with CAR T-cell therapy.

Tkacz and a team of investigators looked to assess the survival outcomes and economic impact of CAR T-cell therapy in older patients with DLBCL in a real-world setting in the United States.

Pharmacy Times®: How has CAR T-cell therapy changed the treatment landscape of R/R DLBCL?

Joseph Tkacz: CAR T has had a profound impact on the treatment landscape for DLBCL and has become a standard of treatment for patients with R/R disease.

Pharmacy Times®: Why is it important to assess the real-world outcomes and economic impact of receiving CAR T-cell therapy for older patients with DLBCL?

Joseph Tkacz: First of all, older patients account for more than half of patients with DLBCL, and 30% are over age 75 years, so this is an important subgroup of patients with DLBCL. However, older patients were under-represented in CAR T trials, and there is very limited real-world data on CAR T-cell therapy in this population.

Understanding the real-world efficacy and cost associated with CAR T-cell therapy in older patients provides critical information for decision makers, providers, and patients when considering personalized and optimal treatment options for older patients.

Pharmacy Times®: What were the outcomes assessed in this real-world study, and how were they measured?

Joseph Tkacz: Partnering with ADC Therapeutics and using a 100% Medicare Fee-for-Service database, we first estimated the proportion of older patients with DLBCL treated with CAR T-cell therapy in third and later line settings. Among those who received CAR T regardless of line of therapy, costs, and health care resource use within the 90-day period following therapy were assessed, as well as overall survival (OS) and event free survival (EFS).

Further, OS and EFS were operationally defined as time until death, and time to subsequent DLBCL treatment or death. EFS was a proxy measure of treatment success.

Pharmacy Times®: What were the main findings of the study?

Joseph Tkacz: Results demonstrate that the usage of CAR-T is low in older patients with DLBCL, especially in patients older than age 75 years, as only 13% of these patients received CAR T. Among older patients who received CAR T, this therapy was associated with favorable EFS comparable to outcomes observed in the phase 2 studies. However, less favorable EFS was observed in patients aged 75 years or older, with a median OS of 17.1 months and no statistical difference observed across different age groups.

Pharmacy Times®: What are the implications of these study results on treatment practice?

Joseph Tkacz: Long term remission was observed in older patients, with less favorable treatment success observed in patients aged 75 years or older. Meanwhile, CAR T therapy use in older patients was low, especially among patients aged 75 years or older.

Health care costs associated with CAR T were also high. Overall, results indicate that there is unmet need for more accessible, effective, and tolerable therapy in older patients with R/R DLBCL, especially in patients aged 75 years or older.