Older patients with non-Hodgkin lymphoma can be treated successfully with CAR T-cell therapy

Dr Karl Kilgore - Avalere Health, Bowie, USA

This was a presentation about CAR T-cell therapy. It is, in fact, the first real world analysis of how CAR T is being provided in hospitals with real patients outside of clinical trials that is the first to be published with using real world data. We used the 100% Medicare Fee-for-Service claims data to get a picture of the real world use in CAR T. What we found was in our 207 patients who were the first Medicare patients to receive CAR T after its approval in the US, in those 207 patients we found that, one, a lot of them were older than what we see in the clinical trials and with multiple comorbidities. We found, furthermore, that CAR T therapy can be used very successfully even in those kinds of patients in terms of healthcare utilisation, survival and overall costs.

Based on your results, how should physicians manage these elderly patients in their clinic? What should they look out for?

The important finding for the physicians is that when you look at the trials, when you look at the trial data, those patients tend to be younger, those patients tend to be the average age, the median age in the clinical trials, 56, 58. We’ve shown that you can use CAR T successfully in older patients. Half of the patients in our study were older than 70 years of age. That then opens the opportunity for the practising physician, who the decision is up to him or her, whether to use CAR T-cell therapy but it opens up the potential opportunity for them to consider using this particular innovative type of treatment for the older patient, for the patient with multiple comorbidities.

This drug is used for relapsed refractory diffuse large B-cell lymphoma, a very aggressive form of NHL. These patients, patients with this disease, when their cancer recurs after a couple of rounds of prior treatment, their treatment options traditionally are very limited. CAR T-cell opens a new opportunity, a new treatment opportunity for these kinds of patients with advanced lymphoma that wasn’t available before. So we want to make sure that enough information is available to the practitioners to feel comfortable choosing from the entire array of options even for the older patient.

What are some of the advantages of this type of study? Because it was using real world data as opposed to a clinical trial.

Absolutely. What do to the patients look like? Clinical trials, of course, are controlled clinical trials, the real world is not. Especially with the older patients, just by virtue of their age, patients are going to have additional comorbidities beyond their cancer. In our study, in fact, over 50% of the patients had significant chronic diseases over and above their lymphoma – heart disease, chronic obstructive pulmonary disease, chronic kidney disease, these are the kinds of conditions that would eliminate those patients in many cases, we can’t say in every case but in many cases would have eliminated those patients with those diseases from the clinical trials. So that’s an important takeaway, that’s an important takeaway from this.

Also with the real world data we can look at the costs, we can look at healthcare utilisation in the real world. Why would that be different, you may ask. It’s because in clinical trials what the clinicians do is largely prescribed by the clinical trial protocol. In the real world it’s patient and physician making the best decisions they can in that particular relationship. So being able to see what’s happening in the real world you actually get a much more accurate picture of what the healthcare utilisation is and is likely to be in the real world, what the costs of treatment are likely to be and the real world outcomes. These are real patients not patients taken from a controlled trial where maybe they’ve eliminated some of these comorbidities, maybe they’ve eliminated patients with other characteristics that make them less representative of treatment in the real world.

Finally, what’s next for this research? Are you planning to elaborate on this study?

We’ve barely scratched the surface. First of all, what our study reports is literally the first year of CAR T-cell since it was approved in the US. So this is very early experience with a novel, innovative treatment. So using the same dataset that we have now, the 100% Medicare Fee-for-Service data that we have, we’re going to continue on and look and see how the experience changes as more hospitals and clinicians adopt this therapy, look and see how the resource utilisation, how the patients are treated, how that might change. I don’t have any data on it yet but, for example, at this conference itself there is some very recent data being presented that shows a reduction in the severity and aggressiveness of the treatment required for some of the adverse events of CAR T-cell therapy. So we’re already starting to see here in the third year of CAR T-cell experience, the very beginning of the third year of experience, we’re already starting to see that the greater familiarity, the increased frequency of the use, the more widespread use of this, is we’re starting to see a positive benefit as individuals as it is more widely adopted, as the practitioners have more practical, real world experience with it.

So we’re going to look at that and we’re also considering… That’s the first objective, is we have a nice baseline, let’s compare and see how the treatment outcomes evolve.

And anything else you’d like to add at all?

Just that the main message is older patients, multiple comorbidities, can be successfully treated with CAR T-cell therapy and show improved survival outcomes, can show reduced utilisation and costs after treatment compared to prior to receiving the treatment.