FDA places a partial hold on all venetoclax clinical trials for multiple myeloma (MM) patients
Dr. Talha Munir works with Dr. Peter Hillmen and others at Leeds in the UK on fast moving trials for chronic lymphocytic leukemia (CLL).
This is the second half of my interview with him from Dublin, Ireland where we met to help with the launch of CLL Ireland or CLLI.
We discussed drugs combinations.
Now that we have several strong novel medications for CLL, combining the new drugs should to be studied to see if we can improve management.
Take away points:
- As CLL has not yet been cured outside of a high-risk transplant, it makes sense to look at drug combinations.
- Research is looking at using biological markers to predict response and not to wait for the patient to show signs of progression of chronic lymphocytic leukemia.
- At Leeds, in many trials they are using ibrutinib as the foundational drug and adding other drugs to it to see if:
- We can achieve deeper remissions than with single agent ibrutinib.
- We can safely stop therapy if we reach MRD– (Minimal Residual Disease) negative status ( no cancer cells seen in one in 10,000 or more cells) in both the blood and the marrow.
- Our CLL will respond to reinstituting therapy should the CLL cells become detectable again.
- The two drugs Dr. Munir is studying in combination with ibrutinib are obinutuzumab, a powerful monoclonal antibody against CD20. (Here is a link to an overview of how antibody therapy works in CLL) or venetoclax, another oral agent that promotes CLL cell to suicide through the BCL-2 pathway. (Here is a link to one of the many article we have on venetoclax that helps explain how it works).
- Early results of his ibrutinib and venetoclax trial in relapsed and refractory patients are positive.
- This combination will likely move frontline in research and will be asking similar questions.
The very early data that Dr. Munir references on the ibrutinib and venetoclax trial was presented at EHA (European Hematology Association) meeting in June 2017 and was reassuring about the safely of the combination and exciting about the early strong responses.
Here is a link to Dr. Jones research presented at ASH 2016 and referenced by Dr. Munir.
Please enjoy my interview with Dr. Munir from Dublin at the end of April, 2017. You can read the transcript here, or watch the video below.
One of the many things I like about this research is that it is fast, adaptive and is focused on non-chemo combinations.
Stay strong
Brian Koffman, MD 9-26-17
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