CAR-T Therapy Is Promising for Older, Difficult-to-Treat Patients With NHL

CAR T-cell therapy is an emerging targeted therapy that has large potential for patients whose disease is relapsed or refractory.

Currently, only tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta) are approved by the FDA, while many other CAR T-cell treatments remain in the clinical trial phase.

In an interview with OncLive®, a sister publication to Oncology Nursing News®, Karl Kilgore, PhD, senior research scientist, Avalere Health, discussed the earliest experiences of CAR T-cell. therapy in the real-world, and how it impacted Medicare patients with large B-cell lymphoma.They spoke at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, held December 7-10 in Orlando, Florida.

OncLive®: What was your rational for conducting research on Medicare patients receiving CAR T-cell therapy for non-Hodgkin’s lymphoma?

Kilgore: The patients who have the [large B-cell lymphoma] have traditionally had very few treatment options once their cancer recurs. After a few courses of treatment, there haven’t been a whole lot of choices for further treatment down the road. A couple years ago, a new option was approved. So, this is a recent enhancement to the armamentarium that oncologists have, that hematologists have, and so we wanted to take a look at the earliest experience we could find in the real world to see how it was being used, what the patient’s looked like, what the outcomes were.

It’s a descriptive study. We wanted to get a comprehensive view of the landscape of the CAR-T patient in the real world. We used Medicare, FIFA service, 100% claims data. So, we have the data for all Medicare patients, part A and B, and so that was a source of our data to get the first real world look.

What did the analysis show?

We looked at the first year of CAR-T in the real world. It was approved in these 2 products that are on the market now. [They] were approved in the latter half of 2017, so we looked at a full year of CAR-T. We looked at 6 months before CAR-T and looked at the patient characteristics, and then we looked at them 6 months after.

These were Medicare-aged patients. Half of the patients were over 71, [compared] to the average age of those in the pivotal clinical trials, 56-58 kind of range. Also, we found that these patients, not surprisingly in a Medicare population, had multiple co-morbidities — other conditions over and above their lymphoma for which they were being treated. In many cases, over 50% of the patients in fact had severe chronic conditions, chronic heart failure, chronic pulmonary disease, chronic kidney disease, the kinds of conditions that would have excluded at least some of the patients from the clinical trials. Nevertheless, we found older patients and patients with multiple co-morbidities being treated with CAR-T.

Now, what else did we find? By comparing healthcare utilization and costs in the 6 months prior to getting CAR-T with the 6 months after CAR-T, we found significantly lower utilization of hospitals, fewer hospitalizations, significantly fewer days spent in the hospital at a population level (on a PPPM basis if you will), the incidence of emergency department visits was cut down by 1/3, and the overall number of visits on a per-patient per-month basis cut almost in half. Overall healthcare costs, all-cause healthcare costs, 6 months before vs 6 months after, exclusive of the cost of the CAR-T episode itself, overall costs decreased by I believe 37%. So, what we found was that older patients, average age of 70 who had multiple co-morbidities, can be successfully treated with this new, innovative treatment.

What would you say the impact of these data will be?

I don’t want to predict the future, but I think that the data do paint a fairly optimistic view of what CAR-T can do for these very difficult-to-treat patients with relapsed/refractory diffused large B-cell lymphoma. There aren’t a lot of other options out there and we’ve shown, at least demonstrated with descriptive real-world data, that older patients with multiple co-morbidities can show a very positive effectiveness. Certainly it might mean that the physicians might think of CAR-T as a viable treatment option, even for those kinds of patients like I described to you. It could be a viable treatment option for those patients, and perhaps even earlier on in the course of treatment.