Transcript
Hi, my name is Neil Kay. I work at Mayo Clinic, and my specialty is hematology.
My focus for the last many years has been chronic lymphocytic leukemia. This disease, unfortunately, is probably the most common leukemia in North America, and it's still not routinely cured, perhaps with the exception of bone marrow transplant.
Currently, we have been involved in major, Phase 3 clinical trials. I reported on one today, E1912, which is a North American, intergroup, Phase 3 trial, which compared the prior gold standard of fludarabine, cyclophosphamide, and rituximab, or FCR, to novel agents which are not technically called chemotherapy. They're oral agents that attack the B-cell pathway.
In this case, it was ibrutinib/rituximab versus FCR. This was for previously untreated young patients under the age of 70 who did not have 17p, which is a high risk factor. In brief summary, the results of that trial, which is now at the 3-year follow-up time point, is that the ibrutinib/rituximab arm, somewhat surprisingly, has had a significant progression-free survivorship.
The bigger surprise was the overall survivorship over FCR. The ibrutinib/rituximab arm, currently, based on the results of that trial, would seem to be the primary treatment regimen of choice for young CLL patients who are fit and who do not have 17p.
There will be subsequent Phase 3s that test time-limited therapy. The trial I just talked about, E1912, does use indefinite ibrutinib therapy for responding patients. We'll look forward to the results of that next trial, which will build on the results of E1912.
