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What to Expect When Treatment Begins


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Talking to Your Children About Cancer:  A Patient?s Perspective
Talking to Your Children About Cancer: A Patient's Perspective


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May 2014 



We are pleased to bring you another issue of

Tidbits. Below, please find an update on some of the data being presented at ASCO this weekend. In addition, we point out some of the initial discussion regarding Ibrutinib resistance. 

May was another busy month for CLL Global. At the beginning of the month, our Board of Directors met to discuss strategy on where our organization is heading. We are busy preparing for our CLL Global Alliance meeting next month. We will bring together CLL experts to discuss new opportunities for advancing CLL research.  


CLL Clinical Trial Data at ASCO  


Over the next few days, you will likely notice a flurry of media coverage on cancer-related topics. That is because the Annual Meeting of the American Society of Clinical Oncology is taking place May 30-June 3 in Chicago.


ASCO is often described as the largest gathering of oncology specialists. At this year's meeting which is the 50th anniversary, CLL specialists will learn the results of many ongoing clinical trials examining a variety of new CLL agents.


Dr. Susan O'Brien (MD Anderson Cancer Center) will present data from the Phase III study comparing ibrutinib vs. ofatumumab in relapsed or refractory CLL. This study known as the RESONATE trial was stopped early due to improved efficacy in the ibrutinib arm. 


Efficacy data will also be presented on patients receiving single-agent ibrutinib therapy for three years.  This study looked at 132 CLL/SLL patients. The overall response rate for these patients was 78%. At three years, 64% of patients remain on study. Durable responses were observed in both treatment naive and relapsed/refractory patients.


The Ohio State University will also present data on ibrutinib in combination with ofatumumab. This study of 71 previously-treated patients showed an overall response rate of 83%. See the article below for more on research to understand resistance mechanisms for ibrutinib.


Data looking at ABT-199 (GDC-199) as a single agent and also in combination with rituximab will also be presented. ABT-199 is an oral, selective Bcl-2 inhibitor that triggers CLL cell death. The initial studies are generating complete and durable responses. 


The CLL community will also be interested to see results of Gilead's Syk inhibitor, GS-9973. This agent was studied as a single-agent and in combination with the PI3k inhibitor, idelalisib. While the combination showed promising activity in CLL, there was an unexpectedly high rate of pneumonitis which resulted in stopping the combination dosing.


As we have discussed in previous editions of Tidbits, there is significant interest in evaluating chimeric antigen receptors (CARs) for CLL. Memorial Sloan-Kettering Cancer Center will present data on seven patients with residual disease following front-line chemotherapy who received CD19-targeted CAR+ T cells as a consolidative therapy. One patient achieved a complete response (CR); two patients had CR in the bone marrow but progressive disease in the lymph nodes; and three patients obtained a partial response. One patient had progressive disease but already had worsening cell counts at the time of infusion. MD Anderson and others will soon be starting CAR studies targeting ROR1, a protein more specific to CLL cells.


These are just some of the studies that will be presented at ASCO. Stay tuned for additional data.




Searching For Ibrutinib Resistance Clues  

To date few patients on ibrutinib have relapsed, and most experience with the agent has been on controlled clinical trials. Now that ibrutinib is FDA-approved and is available commercially, there will be more patients treated with ibrutinib, making it important to understand mechanisms of acquired resistance.


Research groups around the globe are looking for clues as to how patients develop resistance. Ultimately, the goal is to identify which patients may develop resistance and to develop additional treatment options for these patients.  


The May 28 issue of the  New England Journal Of Medicine discusses potential clues to resistance. Research groups at the Ohio State University and Weill Cornell Medical College independently looked at patients treated with ibrutinib who had CLL and acquired resistance to ibrutinib. The goal was to look for mutations that may drive resistance.  


The research points to several potential mutations and also suggests that patients with genetic abnormalities such as 17p- or 11q- may be at risk for relapse. The number of patients sequenced for potential mutations remains very small. A previous presentation by researchers at MD Anderson found different mutations which may be driving resistance. Larger studies are needed to generated a clearer picture.  



CLL Global Board Meeting  

The Board of Directors convened May 7 to review the organization's financial statements and set strategic objectives for the year ahead. Each of the grants awarded from the most recent funding cycle was presented.  Dr. Keating provided an update on CLL research programs. We also reviewed the recently held patient education forums sponsored by CLL Global. The Board found these programs to be extremely beneficial to the patient community and agreed to consider future programs of this nature.  gavel


During the Board meeting, Robert Nichols (Dallas, Texas) was elected as Board chair and Richard M. Jaffee (Chicago, Illinois) was elected as vice chair. In addition, Steve Winfield (Palo Verdes Estates, California) was elected as a new Board member.  


We are thankful for our dedicated Board of Directors. As a group, they provide significant insight and advice to ensure our organization is successful in achieving its mission. Under their guidance, we have awarded almost $21 million in grants for CLL research.   



Next month, we will have an update for you on the CLL Global Alliance meeting. We will also report on the European Hematology Meeting in Milan, Italy. Don't forget that Father's Day is right around the corner. A donation to CLL Global is a wonderful way to show appreciation for your father. Until next month, be happy and well.



CLL Global Research Foundation