Ibrutinib Shows Benefit in the Frontline Setting

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Topics include: Treatment

At the American Society of Hematology (ASH) meeting in Orlando, CLL expert Dr. Jan Burger discussed the results from the RESONATE-2 trial, which studied the use of ibrutinib (Imbruvica) vs. chlorambucil (Leukeran) in the frontline setting in patients over 65. Dr. Burger reviews the medication’s benefits in overall survival, progression-free survival, and in response rates. Learn why Dr. Burger feels it is “compelling to use ibrutinib more in the frontline setting” for elderly patients.

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Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Andrew Schorr:

Andrew Schorr on location at ASH 2015 in Orlando, Florida.  CLL news, I'm with Jan Burger, who is a CLL specialist at MD Anderson in Houston.  Thank you for being with us on Patient Power once again.  

Dr. Burger:

Sure.  My pleasure.  

Andrew Schorr:

So, Dr. Burger, data here from the RESONATE trial, right?  Ibrutinib (Imbruvica) being used first?line.  Many patients are understanding it can be used for people who have been previously treated, but what have you been finding out?  What are the results? 

Dr. Burger:

Yeah, it's the first large randomized study of ibrutinib compared to chlorambucil (Leukeran), another oral agent which has been widely accepted and used in the past since the, I guess, 1960s, and it's been difficult in the past to show major survival benefit compared to chlorambucil in elderly CLL patients.  So with that in mind about 2011, 2012 we thought about designing a trial to compare it side-by-side with chlorambucil and allowing for some patients later to cross over especially on the chlorambucil arm as they progressed. 

So the key data, I think, are that ibrutinib is doing much better in every aspect in terms of progression-free survival, overall survival and also response rates.  There's a clear difference, and with that difference I think it's compelling now to use ibrutinib more in the frontline setting, at least in the elderly patients.  In younger patients, we still have to determine if it's clearly better than chemoimmunotherapy and more intensive treatments, and those trials are ongoing.  

Andrew Schorr:

Okay.  Now, we've talked a lot about different genetic mutations, whether people are 17p and whatever, and the way the labeling is for ibrutinib is it's for people who have been treated or have those deletions, that ibrutinib applies to them, but you're talking more broadly about older patients. 

Dr. Burger:

That's correct, yeah.  So there was no major restriction.  It was for all patients over the age of 65, and 17p deleted patients were actually excluded because we didn't want to have 17p deleted patients ending up getting chlorambucil, which already was felt at that time not to be an optimal treatment. 

But your perception is totally correct.  I think ibrutinib initially in the past years has been developed primarily or there has been strong emphasis on high-risk patients, because these patients really in the past didn't have good alternatives. But now it's also used more broadly across all different patient populations, and it shows great benefit.  

Andrew Schorr:

Okay.  So this is typical, isn't it?  When a powerful agent is used for the sickest people, often it's found to then have utility for people earlier in their course of the disease, and that seems to be happening here.  

Dr. Burger:

That's correct, yeah.  And I thought that was quite a good way to develop the drug. 

Andrew Schorr:

Okay.  All right.  Well, thank you very much for your research.  

Dr. Burger:

Sure, my pleasure. 

Andrew Schorr:

And thank you.  And I think good news for people, particularly older patients as far as having an option.  There's data there to show that there's more effective treatment for you to help you do better.

On location with Dr. Jan Burger from MD Anderson at ASH in Orlando, I'm Andrew Schorr.  Remember, knowledge can be the best medicine of all.  

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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Page last updated on December 9, 2015