iwCLL 2021 | RESONATE-2: ibrutinib and chlorambucil for frontline CLL
Tadeusz Robak, MD, PhD, of the Medical University of Lodz, Lodz, Poland, provides us with an update on the RESONATE-2 trial (NCT01724346), which has implications for the treatment of chronic lymphocytic leukemia (CLL). This trial compared the safety and efficacy of ibrutinib and chlorambucil as a first-line treatment in CLL patients. At a median of 6.5 years of follow-up, the ibrutinib group exhibited a progression-free survival (PFS) rate of 61%, an overall response rate of 92%, and a complete response rate of around 32%. Overall, these results suggest that ibrutinib treatment is feasible over long durations up to around seven years with a tolerable safety profile. This interview was conducted during the 2021 virtual international workshop on CLL (iwCLL).
Transcript (edited for clarity)
Well the RESONATE-2 study was started seven years ago and we have now data concerning results and safety of the drugs used in this study presented during this meeting in the abstract form- in the poster form. As you know, RESONATE-2 is a Phase III study, which compared chlorambucil as the comparator with ibrutinib in the first-line treatment of CLL patients.
A current follow up to seven years was presented and it is worth to know that PFS estimates at 6...
Well the RESONATE-2 study was started seven years ago and we have now data concerning results and safety of the drugs used in this study presented during this meeting in the abstract form- in the poster form. As you know, RESONATE-2 is a Phase III study, which compared chlorambucil as the comparator with ibrutinib in the first-line treatment of CLL patients.
A current follow up to seven years was presented and it is worth to know that PFS estimates at 6.5 years were 61%. We should know that only 18% of the patients were removed from the study due to progression. So, it is important evidence that we can give ibrutinib for very long time. And almost half of the patients, up to seven years are still on the drug. So, I think this is the major observation from this study. Overall response rates were 92% for ibrutinib and the CR rate is growing up to 32% in this study. It is important that the drug can be given for a long time, and I think it is an important to message the hematologist who use this agent.
It also has the worth mentioning that the PFS and OS benefits were sustained when ibrutinib was used in the first-line setting. Low rates of grade three adverse events were seen up to seven years. So, most patients will receive further the drug and we expect the summary of the analysis or the results in the next few years. The observation is now prolonged until 10 years.
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