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Anthony Mato, MD, Talks Real-World Biomarker Testing for CLL, SLL

Transcript: 

Hi, my name is Anthony Mato, director of the CLL Program, associate attending at Memorial Sloan Kettering Cancer Center.

Today, at the ASH meeting, I presented data from the InformCLL Registry. InformCLL is a prospective registry that's been gathering data for approximately the last five years on approximately 1,500 patients with chronic lymphocytic leukemia across the US who have been treated with various types of therapies as per standard of care.

It is largely a community practice registry. About 85 percent of the practices were from the community. This really gives us great opportunity to observe patients with CLL who are being treated, to identify what therapies they are receiving, what their prognostic factors are, what their outcomes are, and how their quality of life could be affected.

The most important thing to emphasize about this registry is that it is observational. It's not trying to influence the standard of care or clinical practice.

What it is trying to do is just observe what's happening and give us a window into clinical practice so that we could potentially see whether or not results from clinical trials are also being generalized in practice and also make some observations regarding potential opportunities for education in order to improve care.

What I reported at the ASH meeting today were the baseline characteristics from the registry, as well as an observation of how frequently appropriate prognostic testing are being performed.

Groups like the iwCLL or the NCCN recommend that all patients should have prognostic testing before a decision is made about first therapy, for example, FISH testing for Deletion 17p, next‑gen sequencing for p53 mutation or IGHB mutational status.

Previously, these tests were only prognostic. No matter what you found, everybody got the same therapy. Over the last five years or so, we have agents like ibrutinib, other BTK inhibitors, venetoclax approved, which performed better in patients with core risk features.

You can argue there is a strong rationale to say perform prognostic testing, analyze and interpret results, and then make a decision about what is the best fit for a patient.

What we found in this study was that a minority of patients, at best, had appropriate prognostic testing performed prior to their first therapy or therapy in a relapsed/refractory setting on the registry.

When I say a minority, when I talk about tests like next‑gen sequencing or IGHV testing, we are talking about less than 15 percent of patients. FISH, about a third of the time.

The bigger result and the more striking result is that even if patients have the right testing, for the subset who had a deletion 17p or a p53 mutation or were IGHV‑unmutated, a significant proportion of the time ‑‑ about 20 to 30 percent of the time – they are still receiving chemo‑immunotherapy.

This is the time period where agents like ibrutinib were widely approved and available in the US, and you could argue that there were better therapies that could have been offered to those patients as a result of the literature that had been accumulating from the many, many randomized studies in the frontline and relapsed/refractory settings.

Great window into clinical practice, important educational opportunity, and then speaks to proof of concept of why registries, and also real‑world data sets are really very important in terms of our understanding of clinical practice and can provide information that can really provide improvement in care.

   

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