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CLL Novel Therapy Patterns, Dosing, and Sequencing: Results of the informCLL Real-World Registry

Journal of Clinical Pathways spoke with Jeff Sharman, MD, at the ASH Annual Meeting and Exposition regarding what the results of the informCLL real-world registry analysis indicate for CLL novel treatment patterns, dosing, and sequencing in practice.

 

 

Listen to the entire podcast from the 2018 ASH Annual Meeting and Exposition.

 

Mr Bessette: So, Dr Sharman, what do the results of the informCLL real-world registry analysis show us in terms of how novel therapies are being used in practice specifically in terms of treatment patterns, dosing, and sequencing?

Dr Sharman: So, we were able to present data on about 1000 patients that we have captured over the last 24-36 months looking at treatment selection – both the front-line and relapse/refractory setting. What we see is that the most commonly prescribed therapy for patients with CLL is ibrutinib, but then when you start to break that down into front-line and relapse/refractory, you see some important differences.

In the front-line setting, about 40% of patients are getting ibrutinib as their prescribed medication and then the remainder, which in aggregate makes up the majority, is either getting bendamustine/rituximab, C20-based treatment, whether that is C20 monotherapy or with the addition of chlorambucil, and a relatively small minority of patients getting FCR.

In the relapse setting, ibrutinib becomes the majority. It is over 50% and again, you see the other regimens constituting the remainder.

There are a couple really important findings. We do find that if you take a regimen like bendamustine/rituximab, which is the most commonly utilized regimen, the median number of cycles patients are getting in the front-line setting is about five. In the relapse/refractory, it is four, which differs considerably from more intensive therapy that we see in clinical trial populations. So, doctors and their patients are backing off of these regimens when given outside of clinical trials.

What is really provocative and I think we can go with some of the rest of this discussion is how we project that is going to change based upon findings here at ASH this year because we have a host of new studies looking at what the proper treatment is in the first-line setting. We have a plenary session of ibrutinib versus bendamustine/rituximab, we have a late-breaking abstract of an ibrutinib-based regimen against FCR both in the elderly, older and then younger populations.  And then finally, we have a press release not to be reported here at ASH, but I anticipate we will see the data soon, from the CLL-14 study looking at the combination of obinutuzumab venetoclax, which is a fixed duration therapy.

Mr Bessette: So, Dr Sharman, what do the results of the informCLL real-world registry analysis show us in terms of how novel therapies are being used in practice specifically in terms of treatment patterns, dosing, and sequencing?

Dr Sharman: So, we were able to present data on about 1000 patients that we have captured over the last 24-36 months looking at treatment selection – both the front-line and relapse/refractory setting. What we see is that the most commonly prescribed therapy for patients with CLL is ibrutinib, but then when you start to break that down into front-line and relapse/refractory, you see some important differences.

In the front-line setting, about 40% of patients are getting ibrutinib as their prescribed medication and then the remainder, which in aggregate makes up the majority, is either getting bendamustine/rituximab, C20-based treatment, whether that is C20 monotherapy or with the addition of chlorambucil, and a relatively small minority of patients getting FCR.

In the relapse setting, ibrutinib becomes the majority. It is over 50% and again, you see the other regimens constituting the remainder.

There are a couple really important findings. We do find that if you take a regimen like bendamustine/rituximab, which is the most commonly utilized regimen, the median number of cycles patients are getting in the front-line setting is about five. In the relapse/refractory, it is four, which differs considerably from more intensive therapy that we see in clinical trial populations. So, doctors and their patients are backing off of these regimens when given outside of clinical trials.

What is really provocative and I think we can go with some of the rest of this discussion is how we project that is going to change based upon findings here at ASH this year because we have a host of new studies looking at what the proper treatment is in the first-line setting. We have a plenary session of ibrutinib versus bendamustine/rituximab, we have a late-breaking abstract of an ibrutinib-based regimen against FCR both in the elderly, older and then younger populations.  And then finally, we have a press release not to be reported here at ASH, but I anticipate we will see the data soon, from the CLL-14 study looking at the combination of obinutuzumab venetoclax, which is a fixed duration therapy.

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