ASH 2013: Dr. Furman: Idelalisib in Fragile CLL (Chronic LymphocyticLeukemia) Patients
I am going to be busy posting several videos from ASH 2013 because some of the new data that I will be discussing from ASCO 2014, May 30-June 3 in Chicago will be the longer term follow-up data from the same studies.
Today is a short interview with Dr. Furman on his late breaking abstract presented at ASH 2013.
Dr. Furman was the lead investigator and author in this important NEJM article, arguably the world's most prestigious medical journal. Dr. Furman, out of Cornell Weil, was deeply involved in the first in human trials of both ibrutinib and idelalisib. This important post from only one year earlier at ASH 2012 seems like ancient history as we have learned so much more about these game changing treatments. Worth reviewing to see just how far we have come in such a short time.
The study that we are discussing in the video (click here for the abstract) is pretty interesting for many reasons.
The first is the the particular population that was targeted.
I have blogged in the past about how we determine whom is fragile and whom is elderly. The CIRS score is one way to quantitate how sick we are besides having the obvious problem of CLL that needs treatment.
The group that was studied here was those of us who were likely not be able to tolerate a full course of chemo-immunotherapy due to our co-mordid conditions.
Turns out this group was also a tough group to treat too. 80% were unmutated and 45% had the dreaded deletion at 17p.
This combo of fragile and tough to treat patients is a group that until very recently had few options and so I commend the researchers for looking to these neglected group.
The next interesting aspect of this trial was that it was placebo controlled. One arm was just single agent rituximab and isn't rituximab alone a pretty wimpy comparator? Dr. Sharman and I discussed this in some depth in a prior post. I recommend you review it. That way you will have the opportunity to hear from an important CLL researcher and also from the lead investigator about this same study.
And it did build in from the get-go a cross-over for those who progressed which for me mitigates much of the ethical problems with the trial design issue.
The adverse event profile is encouraging. One case of Richter's. As CLL is being better controlled, Richter's is becoming too often the cancer's escape route
Next, take a look at the data itself. It was very very impressive.
Finally, Dr. Furman gives his perspective on how this study and the other news out of ASH 2013 is influencing therapy choices for not just the fragile CLL patient, but for all of us.
Dr. Furman has been a pioneer and visionary in moving away from chemo based therapies of CLL. I am grateful for what he has done and even more so for the brave patients that have entered his and others' clinical trials, especially the more risky early phase 1 trials. Without their courage, there would be no progress.
Much more to come soon.
I just learned that I will be lecturing on CLL to primary care providers at the Baltimore Convention Center on June 28. This is an introductory lecture with videos from interviews with Drs. Kipps and Wiestner and others. I'll be there June 26-29 and leave from there for Columbus, OH for every 84 day visit to Dr. Byrd in my CLL trial at OSU. Talk about having skin in the game. Please come, hear the lecture and visit. The day before I will be also speaking on gout and CAM. See this link below for my US lecture "tour" schedule. This will be for CME, continuing medical education, that is intended mostly family doctors but many sophisticated patients find the presentations very helpful. And it's free. I would love if you could drop by and say hello.
Today is a short interview with Dr. Furman on his late breaking abstract presented at ASH 2013.
Dr. Furman was the lead investigator and author in this important NEJM article, arguably the world's most prestigious medical journal. Dr. Furman, out of Cornell Weil, was deeply involved in the first in human trials of both ibrutinib and idelalisib. This important post from only one year earlier at ASH 2012 seems like ancient history as we have learned so much more about these game changing treatments. Worth reviewing to see just how far we have come in such a short time.
The study that we are discussing in the video (click here for the abstract) is pretty interesting for many reasons.
The first is the the particular population that was targeted.
I have blogged in the past about how we determine whom is fragile and whom is elderly. The CIRS score is one way to quantitate how sick we are besides having the obvious problem of CLL that needs treatment.
The group that was studied here was those of us who were likely not be able to tolerate a full course of chemo-immunotherapy due to our co-mordid conditions.
Turns out this group was also a tough group to treat too. 80% were unmutated and 45% had the dreaded deletion at 17p.
This combo of fragile and tough to treat patients is a group that until very recently had few options and so I commend the researchers for looking to these neglected group.
The next interesting aspect of this trial was that it was placebo controlled. One arm was just single agent rituximab and isn't rituximab alone a pretty wimpy comparator? Dr. Sharman and I discussed this in some depth in a prior post. I recommend you review it. That way you will have the opportunity to hear from an important CLL researcher and also from the lead investigator about this same study.
And it did build in from the get-go a cross-over for those who progressed which for me mitigates much of the ethical problems with the trial design issue.
The adverse event profile is encouraging. One case of Richter's. As CLL is being better controlled, Richter's is becoming too often the cancer's escape route
Next, take a look at the data itself. It was very very impressive.
Finally, Dr. Furman gives his perspective on how this study and the other news out of ASH 2013 is influencing therapy choices for not just the fragile CLL patient, but for all of us.
Dr. Furman has been a pioneer and visionary in moving away from chemo based therapies of CLL. I am grateful for what he has done and even more so for the brave patients that have entered his and others' clinical trials, especially the more risky early phase 1 trials. Without their courage, there would be no progress.
Much more to come soon.
I just learned that I will be lecturing on CLL to primary care providers at the Baltimore Convention Center on June 28. This is an introductory lecture with videos from interviews with Drs. Kipps and Wiestner and others. I'll be there June 26-29 and leave from there for Columbus, OH for every 84 day visit to Dr. Byrd in my CLL trial at OSU. Talk about having skin in the game. Please come, hear the lecture and visit. The day before I will be also speaking on gout and CAM. See this link below for my US lecture "tour" schedule. This will be for CME, continuing medical education, that is intended mostly family doctors but many sophisticated patients find the presentations very helpful. And it's free. I would love if you could drop by and say hello.
Labels: ASH 2013, Chronic lymphocytic leukemia, Clinical Trial, CLL, Dr. Furman, ibrutinib, Idelalisib, interviews, Video
posted by Brian Koffman at
11:59 AM
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