Wednesday, December 3, 2014

ASCO 2014: Dr. Susan O'Brien Outlines Open Trials of Novel Agents and Equipoise in Trial Design for CLL (chronic lymphocytic leukemia)

In the third part of my interview at ASCO 2014, Dr. O'Brien points out the advantages of being in a clinical trial, including the real financial advantages of getting the trial drug for free. However do remember that the standard of care of drugs such as rituximab are not free. The labs and imaging are not usually free.

The one exemption are trials at the NIH where all costs are paid by our tax dollars. This is is the only way that most of those with no insurance or from out of country can afford  to be in a  clinical study.

Some of the active trials Dr. O'Brien asks us to consider is the phase 1 trial of the very promising second generation BTK inhibitor, ACP-196 that seems to be more selective and has longer binding. Nothing published yet, the early buzz is positive

TG Therapeutics has its next generation anti CD-20 monoclonal antibody and its PI3K inhibitor combined in a promising trial.

The CLL arm of trial of "Ublituximab + Ibrutinib in Select B-cell Malignancies" is already closed.

There is an ibrutinib versus ibrutinib plus rituximab trial at MD Anderson for relapsed patients. Free ibruinib!

The list keeps growing. Please check out when you are considering therapy. We need more options and the only way we get them is through trials, and the only way trials happen is if patients enroll (and their doctors recommend them).

Finally Dr. O'Brien eloquently addresses the issue of equipoise in clinical trials. This ASCO post article from 2013 should be mandatory reading for all patients and all trialists. Please listen carefully to all that she has to say, and how these breakthrough medication have changed how we should design future research. There are lives in the balance.

I love her blunt talk: "They will have to allow cross-overs."

Here is Dr. O'Brien. Again, my apologies for the poor audio quality.

If you haven't heard the prior two sections of the interview, please check them out.

Big news here in the next day or two.

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Anonymous Anonymous said...

Thanks for the quick post of the third segment Brian! Hope you enjoy SF and get some good info at ASH.

With all the excitement over the past few years and keeping close to all the trial data, I was disheartened and a little shocked when my CLL doctor said I needed treatment (I am untreated) fairly soon and FCR would be at the top of the list for consideration. These agents are saving lives but sadly not yet much of a factor for untreateds with good markers.

December 4, 2014 at 8:33 AM  
Anonymous Anonymous said...

I'm in the same situation as the person above. I'm very close to treatment and all I hear is FCR or maybe just R but no promises on just R from my oncologist. He’s very conservative and he’s mentioned that numerous times. Finding a trial that accepts untreated folks is very limited or maybe I’m not looking in the right place.

BUT wait, I do get it, the relapsed and refractory folks should come first because they have the most to gain in the trial. So where’s the untreated folks fall in ??? Do we need to go through the “rite of passage” down the chemo path first ??? Shouldn’t there be trials focused on first line therapies? Or are they out there and I don’t see them?

One other question while I’m on my soapbox. What happens AFTER the trial? Say we get a good response from the drug and a relatively progression free life is obtained…is there a provision in these trails to remain on the drug at a reduced cost AFTER the trials. Is that normal or will the costs revert to what the market will bear?

December 5, 2014 at 8:53 AM  

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