Dr. Nitin Jain of MD Anderson discusses the game changing RESONATE 2 trial that compared chlorambucil to ibrutinib in the frontline setting for chronic lymphocytic leukemia (CLL) for those patients over 65.
Take Away Points
- Ibrutinib proves superior in all outcomes to chlorambucil
- This trial should lead to broader approval for ibrutinib for treatment-naïve patients in 2016.
I have already discussed the ethical and design issues inherent in a trial that uses chlorambucil as its comparator in this article here in the CLL Society website and in my commentary in a yet to be published article for Clinical Oncology News.
That said, RESONATE 2 clearly demonstrated the superiority of ibrutinib over an old school and rather ineffective chemotherapy that is rarely used in the USA. The result was no surprise.
Here is a link to the important ASH abstract.
Here is a link to the NEJM article published the same day as the oral presentation at ASH 2015 in Orlando, FL.
What this trial will likely do is move ibrutinib to the frontline setting for more than just those of us with 17p deletion. The FDA should decide in 2016 whether ibrutinib will be available for all treatment-naïve patients or only for those over 65.
It is important to compare and contrast these positive results to the unexpected increased incidence of adverse events discovered when idelalisib was studied frontline in a trial that was to explore its use in combination with ofatumumab. Those results were a surprise to many.
That is why we do trials.
Dr. Jain discusses these and other research findings from ASH 2015 in Orlando.
Brian Koffman, MD 1/18/16