Sunday, May 12, 2019

Acalabrutinib Phase III ASCEND trial met primary endpoint at interim analysis in relapsed or refractory chronic lymphocytic leukemia and will stop early

This trial in previously treated CLL patients showed a clinically significant progression free survival when compared to a combination regimen of rituximab plus physician’s choice of idelalisib or bendamustine. No new side effects or problems were noted.
While not unexpected, it is important to have this trial confirmation that another BTK inhibitor, like ibrutinib has proven to save lives.
This is more good news for CLL patients. Acalabrutinib is already approved for mantle cell lymphoma (MCL) and hopefully will be soon approved for us CLL patients based on this and Phase 3 trials that should have positive results soon.
While not approved for CLL, because it is approved for MCL and is part of the NCCN guidelines for CLL, it is already an option today for appropriate CLL patients if your doctor pushes for it.
Here is a link to a nice review of the data we have so far and more trial news.
Here is the official press release.
It is good to have more choices of all these great drugs. Can’t wait for approval to make it easier to access.
Stay strong,
Brian Koffman MDCM DCFP, DABFM, MS Ed
Co-Founder, Executive VP and Chief Medical Officer
CLL Society, Inc.


Anonymous Mark Taormino said...

Very encouraging news. My family member is likely failing Ibrutinib, and will need another line of therapy. Doctor suggested Copiktra, but I find little information. Is there anything on your blog you can point out? Acalabrutinib is surely exciting; could you guesstimate approval timelines because this is a breakthough therapy? Thank you again for all you do Dr. Koffman.

July 10, 2019 at 8:03 PM  

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