Karl M. Kilgore, PhD, discusses how results of real-world analysis may impact the utilization of CAR T-cell therapy for older patients with relapsed/refractory diffuse large B-cell lymphoma.
Karl M. Kilgore, PhD
Results of real-world analysis presented at the 2019 ASH Annual Meeting demonstrated that patients with diffuse large B-cell lymphoma (DLBCL) who are older and with multiple comorbidities can successfully be treated with CAR T-cell therapy, and hospitalization rates and costs were lower posttreatment compared with before patients received therapy, said Karl M. Kilgore, PhD.
There are 2 CAR T-cell therapies currently approved by the FDA in lymphomas. In October 2017, the FDA approved axicabtagene ciloleucel (axi-cel; Yescarta) for adult patients with relapsed/refractory non-Hodgkin lymphoma, including DLBCL.
In May 2018, tisagenlecleucel (Kymriah) was approved to treat adult patients with relapsed/refractory large B-cell lymphoma, including DLBCL, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma after ≥2 lines of systemic therapy.
"Traditionally, patients with DLBCL had very few treatment options upon recurrence," said Kilgore. "The recent armamentarium enhancement with CAR-T led us to look at a real-world experience with these agents. We wanted to get a comprehensive view of the landscape of CAR-T patients."
In the analysis, investigators included 177 Medicare patients with non-Hodgkin lymphoma who had multiple comorbidities and had received ≥2 prior lines of therapy. The median age was 70, and 43% of patients had comorbidities that would exclude them from clinical trials, such as renal and heart failure. The pre-index period was defined as 6 months before the first CAR T-cell infusion; the post-index period was 100 days after the date of the first infusion and association inpatient stay.
At 1-year posttreatment, results of the analysis showed that exclusive of CAR-T cost, median overall healthcare cost was reduced from $51,999 in the pre-index period to $14,014 post-index. Additionally, pre-index overall healthcare cost per-patient-per-month (PPPM) was $9749 compared with $7121 per 1000 patients, leading to a 27% decrease in costs.
The median hospitalization days were also reduced from 7 days pre-index to 5 days post-index.
"Certainly, these results may indicate that physicians should think of CAR-T as a viable treatment option for [older, pretreated patients], perhaps even utilizing it earlier in treatment," said Kilgore.
In an interview during the 2019 ASH Annual Meeting, Kilgore, a senior research scientist at Avalere Health, discussed how these results may impact the utilization of CAR T-cell therapy for older patients with relapsed/refractory DLBCL.
OncLive: Could you provide an overview of this real-world analysis?
Kilgore: We looked at the first year of CAR T-cell therapy in the real-world: 6 months before treatment, and 6 months after. In terms of patient characteristics, we found that half of the patients were older than 71 years old. The average age of patients in the pivotal clinical trials [that led to the approval of CAR T agents] was around 57.
Not surprisingly, given the Medicare-aged cohort, we found that these patients had multiple comorbidities. In fact, over 50% of the patients had severe conditions including heart failure, chronic pulmonary disease, and chronic kidney disease. These are the types of conditions that would have excluded a least some of the patients from the clinical trials.
Importantly, we found significantly lower utilization of hospitals, fewer hospitalizations, and days spend in the hospital based on an analysis in which we compared healthcare utilization and cost 6 months prior to CAR T and 6 months after CAR T.
The incidence of emergency department visits was cut down by one-third and the overall number of visits on a PPPM basis was cut almost in half.
Overall, the all-cause healthcare cost 6 months before vs 6 months after, exclusive of the cost of the CAR T episode itself, decreased by 27%.
In short, older patients with multiple comorbidities can be successfully treated with this new, innovative treatment. It reduces hospitalizations, emergency department visits, and overall health costs.
Was the cost of CAR T-cell therapy factored into the analysis?
In terms of the utilization and cost associated, we reported on the CAR T-cell episode separately. We compared pre-cost and utilization with post-cost and utilization exclusive of the cost of the treatment itself.
How would you describe the impact of these data?
I don't want to predict the future, but the data do paint a fairly optimistic view of what CAR T-cell therapy can do for these very difficult-to-treat patients with relapsed/refractory DLBCL.
There aren't many options out there, and we have at least demonstrated with descriptive real-world data that older patients with multiple comorbidities can show a positive effectiveness.
Is there anything else from your presentation that is important to highlight?
We are going to continue this research. As I said, we have the first year of CAR T-cell therapy [real-world] experience, but this is still very early experience. What we have provides a solid thorough baseline of how CAR T is used in its infancy, but we want to continue down this path with the Medicare population, as well as expand into some other populations to get a comprehensive sense [of the patients being treated with CAR T].
Let’s look at another cohort of patients 2 years down the road to hopefully see how outcomes are continuing to improve.
Kilgore KM, Mohammadi I, Schroeder A, et al. Medicare patients receiving chimeric antigen receptor t-cell therapy for non-Hodgkin lymphoma: a first real-world look at patient characteristics, healthcare utilization and costs. Presented at: 2019 ASH Annual Meeting; December 7-10, 2019; Orlando, FL. Abstract 793.