Maintenance Cessation in MRD Negative Patients | Neha Korde, MD | ASH 2022

Hi, my name is Dr. Neha Korde. I'm an associate professor at Memorial Sloan Kettering in New York City. So it's a pleasure for me to be here today talking about the results of our abstract. This study is basically a maintenance cessation study in patients that are MRD negative. So what we were interested in finding out about with this study was that patients that are MRD negative while on maintenance therapy for a sustained amount of time, we wanted to see whether or not once you take them off therapy, how long their MRD durability will last. So we know that maintenance therapy gives a benefit for patients, but we don't know when is the appropriate time to stop patients off therapy. So with this study, the design of the study is to enroll 50 patients. So this is an interim analysis where we've already enrolled 28 patients and we're updating essentially 28 patients' results. So with this study, what we did was we took eligible patients that were MRD negative for at least three years with a minimum requirement of 10 to the minus five while on their maintenance therapy. Once enrolled onto the study, patients stopped whatever maintenance therapy they were on. It didn't have to be specifically lenalidomide. And then patients were essentially went on to surveillance for MRD negative status routinely every six months for with the bone marrow biopsy, but also PET scans every year. And we were following these patients for a total of three years. The primary endpoint of the study is to look at the 12-month MRD status after stopping maintenance therapy. But we also have a number of different correlatives that we're looking at, including quality of life, and then also overall when patients might relapse or not. So what we found in this interim analysis is with 17 patients thus far, 15 out of 17 were in MRD negative at the 12-month mark after stopping maintenance therapy. What we also see is that basically three patients so far have actually progressed while coming off of their maintenance therapy. Two of these patients were clinically progressing. One actually just converted from MRD negative status just to positive status. Interestingly enough, what we did was we took that one patient that was MRD positive and then put them back on their maintenance therapy and found that they reconverted back to maintenance MRD negativity status. One of the other things that we're looking at with the study is to look at quality of life outcomes for our patients. So we collected quality of life, patient reported outcomes at baseline, and then consistently followed our patients with surveys throughout the study. So one thing that we found out was that at baseline upon enrollment on the trial, patients were actually doing fairly well with really great health quality of life domain scores when it comes to physical function, fatigue, sleep, emotional status. And so that was kind of a surprising finding for us. Another thing that we realized kind of when we were tracking our patients throughout the study was that their quality of life really has not changed very much since stopping their maintenance therapy. So right now where we are with this study is that we're at the goal of still recruiting more patients onto the study to our target enrollment of 50 patients. We do realize that patients are tolerating the fact of stopping their therapy really well. They're doing really well off of therapy. And we continue to sort of understand and find out how long their MRD durability will last once stopping therapy.