Thursday, June 27, 2013

More News on Ibrutinib

The New England Journal of Medicine (NEJM) is arguably the most prestigious medical journal in the world. It is not easy to get your research into its pages and when you do, it is usually because you have moved the needle of medical science in an important way.

My daughter, when she was eleven years old, had a letter published in its pages that was picked up in the national news.

Check out  http://www.nejm.org/doi/full/10.1056/NEJM199204163261612

Dad has been published in CMAJ (Canadian Medical Assoc. Journal) and AFP (American Family Physician), but never in the NEJM.

The article on the ibrutinib where my doctor at OSU, Dr. John Byrd, is the lead author is considered groundbreaking news.

But for those of us who are living and breathing CLL everyday, this is hardly anything new.

However the rest of the world and the rest of the medical community doesn't think that much about CLL.

That is of course until it shows up in the NEJM.

Once it did, CNN and Time and Dr. Gupta were all over this CLL breakthrough.

Those of us who regularly read the updates here on my blog or in the CLLSLL Yahoo group or ACOR or at PatientPower long knew the broad outlines of this "breaking story".

But now it is vetted. Now we have the details. Now it is peer reviewed.

Now it is out in the world.

And it is pretty amazing. Please note that these great responses are independent of the usual bad risk factors.

This is an unprecedented improvement in the response rate for us who are the most difficult to treat CLL patients.

There was also an extremely important ibrutinib article on Mantle Cell Lymphoma and a thoughtful editorial on these changes in the same journal.

More on all this content and other news soon.

I have a presentation to give at UCSD to their local CLL support group on July 3 (Please join me at the Commons on the second floor of the Moore Cancer Center at 4 PM if you are interested), and then I am done with travel until my next trip to Columbus in mid July.

What that means is some free time to read, write, and edit the videos from ASCO to post here.

Here is the NEJM abstract on monotherapy. Exciting times. Enjoy.


Targeting BTK with Ibrutinib in Relapsed Chronic Lymphocytic Leukemia 
John C. Byrd, M.D., Richard R. Furman, M.D., Steven E. Coutre, M.D., Ian W. Flinn, M.D., Ph.D., Jan A. Burger, M.D., Ph.D., Kristie A. Blum, M.D., Barbara Grant, M.D., Jeff P. Sharman, M.D., Morton Coleman, M.D., William G. Wierda, M.D., Ph.D., Jeffrey A. Jones, M.D., M.P.H., Weiqiang Zhao, M.D., Ph.D., Nyla A. Heerema, Ph.D., Amy J. Johnson, Ph.D., Juthamas Sukbuntherng, Ph.D., Betty Y. Chang, Ph.D., Fong Clow, Sc.D., Eric Hedrick, M.D., Joseph J. Buggy, Ph.D., Danelle F. James, M.D.,
and Susan O’Brien, M.D. 


Background
The treatment of relapsed chronic lymphocytic leukemia (CLL) has resulted in few durable remissions. Bruton’s tyrosine kinase (BTK), an essential component of B-cell–receptor signaling, mediates interactions with the tumor microenvironment and promotes the survival and proliferation of CLL cells.
Methods
We conducted a phase 1b–2 multicenter study to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of ibrutinib (PCI-32765), a first-in-class, oral covalent inhibitor of BTK designed for treatment of B-cell cancers, in patients with relapsed or refractory CLL or small lymphocytic lymphoma. A total of 85 patients, the majority of whom were considered to have high-risk disease, received ibrutinib orally once daily; 51 received 420 mg, and 34 received 840 mg.
Results
Toxic effects were predominantly grade 1 or 2 and included transient diarrhea, fatigue, and upper respiratory tract infection; thus, patients could receive extended treatment with minimal hematologic toxic effects. The overall response rate was the same in the group that received 420 mg and the group that received 840 mg (71%), and an additional 20% and 15% of patients in the respective groups had a partial response with lymphocytosis. The response was independent of clinical and genomic risk factors present before treatment, including advanced-stage disease, the number of previous therapies, and the 17p13.1 deletion. At 26 months, the estimated progression-free survival rate was 75% and the rate of overall survival was 83%.
Conclusions
Ibrutinib was associated with a high frequency of durable remissions in patients with relapsed or refractory CLL and small lymphocytic lymphoma, including patients with high-risk genetic lesions. (Funded by Pharmacyclics and others; ClinicalTrials.gov number, NCT01105247.)
n engl j med nejm.org 

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1 Comments:

Blogger Randy Shannon said...

Brian,

You are right- many of us CLL Warriors know about the break through from the forums and various email... But as one of those that directly benefits from Ibrutinib, I never tire of seeing it verified as a positive step in the eventual cure...

Dr. Byrd's and CAL 101 and then PCI are the reasons I am here...

Thanks,

Randy

June 27, 2013 at 9:38 AM  

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