EHA 2019 | RESONATE-1 and 2 trials and real-world data
Patrick Thornton, MD, Beaumont Hospital, Dublin, Ireland, discusses the RESONATE-1 and 2 trials and also the comparability of trial data to real-world data in chronic lymphocytic leukemia (CLL) at the 24th Congress of the European Hematology Association (EHA) 2019, held in Amsterdam, Netherlands.
Transcript (edited for clarity)
There are two RESONATE trials, RESONATE-1, RESONATE-2. RESONATE-2 is a frontline treatment for chlorambucil versus ibrutinib in frontline less fit patients. I was involved in the RESONATE-1 study which roughed refractory patients, including patients with a p53 deletion, and the long-term follow up data was presented at last
There are two RESONATE trials, RESONATE-1, RESONATE-2. RESONATE-2 is a frontline treatment for chlorambucil versus ibrutinib in frontline less fit patients. I was involved in the RESONATE-1 study which roughed refractory patients, including patients with a p53 deletion, and the long-term follow up data was presented at last 2018 ASH for seven years, and the good news is that almost half the patients are still on treatment, and the safety profile is extremely acceptable for that population. I think the thing worth mentioning about all these studies, because there was another poster at EHA which compared what’s called real-world data to trial data, and the interesting thing in CLL with novel agents, and the benefit to patients now, is that because the novel agents have a very acceptable toxicity profile, they’re amenable to all patients at all levels of fitness. And many of the trials that I’ve mentioned to you, involve patients with what’s called a CIRS score of greater than six. Now CIRS stands for Cumulative Illness Rating Score. So what that means, a CIRS score of six means that you have a number of other comorbidities, and you may be medicated for other illnesses, and that is essentially when you are dealing with an older population, which represents the majority of CLL patients. You’re dealing with a more realistic population in clinical trials. Previously, clinical trials you have to be very fair to no extra drugs, et cetera. But none of the clinical trials are representative of what we actually see in real life, and the interesting poster for me, how it compared real-world data to trials data, I thought it’s odds were almost identical.
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