John N. Allan, MD:Our patient, in this study, received ibrutinib as third-line treatment. A recent study that was published in 2017 reviewed a relatively large phase II study of patients with marginal zone lymphoma. This was a study whose first author was Dr. Noy. This phase II study enrolled 66 patients with marginal zone lymphoma. All subtypes of marginal zone lymphoma were allowed to enroll. The vast majority of patients, close to 50%, had extranodal marginal zone lymphoma. Another 25% or so had splenic marginal zone lymphoma. The remaining 15% to 20% of patients had nodal marginal zone lymphoma.
What they found was that the drug was active in this disease. There was about a 48% response rate for all patients, with a median progression-free survival of 14 to 15 months and a median overall survival that was not met. In patients who responded, the duration of response was prolonged. The median duration of response was actually not met in this study, which had a median follow-up, at the time of the publication, of about 19 months.
Based on this data, ibrutinib received accelerated approval for patients with marginal zone lymphoma in the relapsed/refractory setting after a prior therapy containing rituximab.
What’s important about the duration of response, as well as the progression-free survival and the response rates, is really looking at this in the context of this being a single agent. The dose that was used was 560 mgthat’s the dose that we use in mantle cell lymphoma. Basically, when we look at this as a single agent and compare it with other drugs that were used in this type of setting, we see very similar response rates. Although this duration of response in the progression-free survival does not necessarily equate to what we see in diseases such as CLL, this is obviously a different disease entity. When we compare it to other drugs that have been studied in smaller patient populations, the response rates are very similar. They’re robust. The drug is well tolerated. At this point in time, many patients, after they’ve had 2 lines of chemoimmunotherapy, are looking for somewhat easier options that might get durable responses and deeper remissions.
Transcript edited for clarity.
A 65-Year-Old Man With Advanced Nodal MZL
History & Physical: