A new analysis of Medicare claims data provides the first real-world evidence using claims data available after the approval of autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, a type of immunotherapy.

These analyses show that CAR-T can be beneficial for a broad population of older patients with DLBCL, including those with multiple chronic conditions.

The research also shows patients spent less time in the hospital and had lower health care costs after CAR-T than they did in the months leading up to it.

The U.S. Food and Drug Administration (FDA) approved the first CAR T-cell therapy for adults with DLBCL in 2017.

However, many of the patients included in the clinical trials leading up to that approval were middle-aged, with a median age of 56-58.

This study used the earliest available Medicare claims data to assess the treatment’s use in Medicare patients age 60 and older, who comprise the majority of Medicare beneficiaries and often have multiple chronic health issues.

“Our findings offer evidence that older patients with multiple comorbidities can be treated successfully with CAR-T,” said lead study author Karl M. Kilgore, PhD, of Avalere Health. “While we don’t know the long-term outcomes yet, nearly three-quarters of the patients were still alive six months post-treatment. Even in that narrow window of time we saw a significant decline in health care utilisation including hospitalisations and emergency room use, which is suggestive of a successful course of treatment.”

DLBCL, a cancer that starts in the white blood cells, accounts for about one-third of the 74,000 cases of non-Hodgkin lymphoma diagnosed in the United States each year.

About 63% of patients survive for five years after their diagnosis.

For those who relapse or have refractory disease, treatment options include chemotherapy, stem cell transplantation, and CAR T-cell therapy.

CAR-T works by reengineering a patient’s own T cells, part of the immune system, to kill cancer cells. Multiple steps are required to collect, modify, and reinfuse T cells into the patient, a process that is typically combined with lympho-depleting chemotherapy and a single infusion of the patient’s modified T cells.

The researchers analysed claims data from patients enrolled in Medicare Fee For Service parts A and B  October 2017-September 2018.

They identified 207 patients with an average age of 70 years who had undergone CAR-T therapy for DLBCL.

Half underwent CAR-T as part of a clinical trial, while the remainder had comorbidities that likely would have excluded them from CAR-T clinical trials.

Comparing health care utilisation in the six months before and after CAR-T therapy, the researchers found patients’ average overall health care costs dropped by 39% after undergoing CAR-T, excluding the cost of the CAR-T treatment itself.

In the months following CAR-T, patients spent less time in the hospital and had half as many emergency department visits than before the therapy.

Only 7.2% had any evidence of subsequent chemotherapy in the claims data, suggesting that the cancer had not returned within the first six months following CAR-T for most patients.

The researchers plan to compare the data to patients with private insurance and to a similar group of DLBCL patients who did not receive CAR T-cell therapy to gain further insights into outcomes and costs.

Source: American Society of Hematology

Watch our interview with Dr Kilgore here.