ASH 2020 | ZUMA-5 update: retreatment of R/R iNHL with axi-cel
Julio Chavez, MD, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, discusses the outcomes of relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) patients retreated with axicabtagene ciloleucel (axi-cel) in the ZUMA-5 trial (NCT03105336). In a group of 11 patients with either follicular (FL) or marginal zone lymphoma (MZL), the overall response rate was 100%, with 91% achieving a complete response. Over 80% of the patients were also still in remission at the last follow-up. No serious adverse events were reported and the rate of toxicities following axi-cel retreatment was slightly lower than after the initial round of therapy. While the CAR-T response was similar to the one caused by the initial treatment, retreated patients exhibited a lower tumor burden. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.
Transcript (edited for clarity)
This study is called retreatment with axicabtagene ciloleucel in patients with refractory non-Hodgkin lymphoma. This is kind of like a subset analysis of patients who relapsed in the ZUMA-5. So the trial, ZUMA-5, as you know, is a multicenter study Phase II that was treating patients with relapsed/refractory indolent lymphomas with axi-cel. The trial allowed patients to be retreated if they have prior response to axi-cel, so we basically reporting the results of the study...
This study is called retreatment with axicabtagene ciloleucel in patients with refractory non-Hodgkin lymphoma. This is kind of like a subset analysis of patients who relapsed in the ZUMA-5. So the trial, ZUMA-5, as you know, is a multicenter study Phase II that was treating patients with relapsed/refractory indolent lymphomas with axi-cel. The trial allowed patients to be retreated if they have prior response to axi-cel, so we basically reporting the results of the study. So the key eligibility criteria was patient had to have at least PR or CR at three months post first treatment. And we wanted to make sure also there was no CD19 loss in tumor cells. And we didn’t want to retreat patients if they had like a grade four or grade three, or grade four CRS or life-threatening effects. So we treated about 11 patients, nine patients with follicular lymphoma and two patients with marginal cell lymphoma.
So one of the interesting findings is that these patients who were retreated, the overall response rate was 100 percent with 91 CR rate. So we still saw a very high response rate, even though they relapse, and they were retreated. The median duration of response for the first treatment was about 8.3 months. So eight months patients went in remission from the first treatment before they had the second treatment. In about nine patients, now, these 11 patients, like 82 percent, they still had ongoing responses at the last follow-up.
One of the other interesting findings is that the toxicities were a little less. These 11 patients who had in the first treatment the CRS was 70 percent in the retreatment and the neurological events were a little bit lower with grade 1 27 percent and 9 percent in the retreatment. So no increase toxicity, essentially similar, I would say and no grade 3 CRS or neurologic events on those patients.
The other thing that we’ve seen in this study was that, in terms of product characteristics in a CAR T-cell expansion, the CAR T-cell expansion and CAR T-cell peak were similar to the first treatment, at retreatment. The tumor burden actually was lower on patients who had retreatment in comparison to the first treatment. And so the conclusion was that retreatment, obviously, it’s a small sized patient. Retreatment led to 100 percent overall response rate with 91 percent CR rate, and about 82 percent of the patients still were in remission after retreatment at the last follow-up.
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