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Unless one is 17p deleted, the best and perhaps only way to get ibrutinib frontline to treat chronic lymphocytic leukemia is within a clinical trial.
Take Away Points:
- There is now data that demonstrates that ibrutinib is superior in specific circumstances as frontline therapy. The data showed clear survival benefits in the RESONATE-2 trial when compared to chlorambucil for patients over 65 years old and in studies with patients with 17p deletion at any age.
- Whether ibrutinib is superior when compared to other more potent therapies used in the frontline setting for patients that do not have 17p deletion has yet to be determined.
- Access to ibrutinib is still limited for treatment-naïve patients who are not 17p deleted.
- These trials offer a chance for access to a non-chemo arm.
This interview with Dr. Neil Kay out of the Mayo Clinic in Rochester, MN was done during a noisy snack break at the 2015 CRC (CLL Research Consortium) meeting in San Diego. The professor outlines two large phase 3 clinical trials that offer frontline non-chemo options for patients who have not had prior therapy. One trial is still open but no longer recruiting, but the other is still open for enrollment. We look forward to seeing the data for both trials in the future.
Information on the trial that is still open comparing ibrutinib + rituximab (R) versus FCR can be found here. Information on the three arm trial that is ongoing but as of very recently is no longer enrolling patients and compares bendamustine + R, versus ibrutinib + R, versus ibrutinib alone can be found here.
The open trial is available at many sites within the USA.
Do your due diligence. Check about the details and crossover protocol.
Enjoy the short interview with Dr. Kay.
Brian Koffman, MD 12/26/15