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The MURANO Phase III Trial

Insights From: Naval G. Daver, MD, MD Anderson Cancer Center; Anthony Mato, MD, MSCE, Memorial Sloan Kettering Center
Published: Monday, Jun 24, 2019



Transcript:

Anthony Mato, MD, MSCE:
Another important trial, which has recently been presented at several congresses and also published in the New England Journal of Medicine, is the MURANO trial.

This is a similar trial design to CLL14 in that it’s a combination of rituximab plus venetoclax. Here, the comparator arm is bendamustine plus rituximab. These are all patients treated in the relapsed-refractory setting. The median number of prior therapies is 1. What’s a little bit different about this population from the patients who we generally see in practice is that very few patients were exposed to a BTK inhibitor. Only about 3% of patients. So that is 1 variation. Head-to-head comparison, the VEN-R [venetoclax and rituximab] was a fixed duration. This time, 24 months instead of 12 months. But the trial was, again, very positive, favoring the experimental arm in terms of response rate, progression-free survival, and even an overall survival advantage suggested here.

We’ve had updated data, which provide further insight into the regimen looking at MRD [minimal residual disease] and how patients at the end of therapy will have detectable disease fare less well than those who have undetectable disease. The data also give us some guidance in terms of the rate of progression after discontinuation of the VEN-R [venetoclax-rituximab] combination. So with about 1 year of additional follow-up, there’s about a 13% rate of progression after discontinuation, which is acceptable. The missing pieces of data that we don’t have are whether these patients can be successfully re-treated with the same combination, how durable those remissions are, and whether there’s any resistance that occurs when you stop and then start again a regimen like that.

I’ve used the VEN-R [venetoclax-rituximab] combination several times in practice. It’s relatively easy to give to patients. Unlike in CLL14, rituximab follows the venetoclax escalation, so the CD20 doesn’t help debulk disease. But the main investment in terms of time for patients is the first 5 weeks of therapy, when they’re escalating the venetoclax and then starting the rituximab. After that point in time—and I haven’t really experienced any TLS [tumor lysis syndrome] cases—the investment for patients is relatively favorable. The drug seems to be well tolerated. The responses, at least at this point, seem to be durable. Of course, I’ll say that noting that the combination has been approved for less than a year, so we really don’t have many patients in clinical practice who are approaching that 24-month discontinuation time point yet.


Transcript Edited for Clarity
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Transcript:

Anthony Mato, MD, MSCE:
Another important trial, which has recently been presented at several congresses and also published in the New England Journal of Medicine, is the MURANO trial.

This is a similar trial design to CLL14 in that it’s a combination of rituximab plus venetoclax. Here, the comparator arm is bendamustine plus rituximab. These are all patients treated in the relapsed-refractory setting. The median number of prior therapies is 1. What’s a little bit different about this population from the patients who we generally see in practice is that very few patients were exposed to a BTK inhibitor. Only about 3% of patients. So that is 1 variation. Head-to-head comparison, the VEN-R [venetoclax and rituximab] was a fixed duration. This time, 24 months instead of 12 months. But the trial was, again, very positive, favoring the experimental arm in terms of response rate, progression-free survival, and even an overall survival advantage suggested here.

We’ve had updated data, which provide further insight into the regimen looking at MRD [minimal residual disease] and how patients at the end of therapy will have detectable disease fare less well than those who have undetectable disease. The data also give us some guidance in terms of the rate of progression after discontinuation of the VEN-R [venetoclax-rituximab] combination. So with about 1 year of additional follow-up, there’s about a 13% rate of progression after discontinuation, which is acceptable. The missing pieces of data that we don’t have are whether these patients can be successfully re-treated with the same combination, how durable those remissions are, and whether there’s any resistance that occurs when you stop and then start again a regimen like that.

I’ve used the VEN-R [venetoclax-rituximab] combination several times in practice. It’s relatively easy to give to patients. Unlike in CLL14, rituximab follows the venetoclax escalation, so the CD20 doesn’t help debulk disease. But the main investment in terms of time for patients is the first 5 weeks of therapy, when they’re escalating the venetoclax and then starting the rituximab. After that point in time—and I haven’t really experienced any TLS [tumor lysis syndrome] cases—the investment for patients is relatively favorable. The drug seems to be well tolerated. The responses, at least at this point, seem to be durable. Of course, I’ll say that noting that the combination has been approved for less than a year, so we really don’t have many patients in clinical practice who are approaching that 24-month discontinuation time point yet.


Transcript Edited for Clarity
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