Caron A. Jacobson, MD, on Next Steps for the Phase 2 ZUMA-5 Study

August 2, 2020

Interim results from the study suggested that axicabtagene ciloleucel (axi-cel) demonstrated significant and durable clinical benefit in patients with relapsed or refractory indolent non-Hodgkin lymphoma.

Interim results from the phase 2 ZUMA-5 study, presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting, indicated that axicabtagene ciloleucel (axi-cel) may be a promising approach for treating patients with relapsed or refractory indolent non-Hodgkin lymphoma.

In an interview with CancerNetwork®, Caron A. Jacobson, MD, of the Dana-Farber Cancer Institute, explained the necessary next steps for this trial and the results they hope to observe for this patient group.

Axi-cel is currently approved by the FDA as a treatment for adult patients with relapsed or refractory large B-cell lymphoma based on findings from the phase 2 ZUMA-1 trial. The agent is indicated specifically following 2 prior therapies for those with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma.

Transcription:

So, I think most importantly is the longer follow up, right? We need to follow these patients over time and understand if they… how long these remissions will really last for. And, so that for this study in particular, that's the most important. Now the marginal zone lymphoma cohort is still enrolling. And so, we will obviously get more data and more mature data for because this is really very preliminary data for that group. I think what we have, what we need to see from this study is, you know, if these responses are durable, and you know, and we're not seeing relapses years after therapy about whether this is something we can move up to an earlier line of therapy for patients. You know, whether it's acceptably safe and provides lasting benefit for patients that it makes it makes sense to move it up into earlier lines of therapy. One particular group that that might make sense to test in is a group of patients who progress early after their first line of therapy. So, people who have… patients who progress within 12 to 24 months of their first line of therapy overall have a generally a worse prognosis than patients who have a longer remission. And so, you may want to highlight those patients for maybe testing this in the second line and seeing if it's safe and makes sense to move up into an earlier line of therapy.

Reference:

FDA. FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma. FDA website. Published October 18, 2017. fda.gov/news-events/press-announcements/fda-approves-car-t-cell-therapy-treat-adults-certain-types-large-b-cell-lymphoma. Accessed June 3, 2020.