Real-World Outcomes of Brexucabtagene Autoleucel for B-Cell ALL With Evandro Bezerra, MD
Recently, at the American Society of Hematology (ASH) Annual Meeting, Dr. Evandro Bezerra, a Hematology Specialist at the Ohio State University Comprehensive Cancer Center, sat down with Oncology Data Advisor to discuss his team's research regarding real-world outcomes of brexucabtagene autoleucel (brexu-cel) for B-cell acute lymphoblastic leukemia (ALL).
Oncology Data Advisor: Welcome to Oncology Data Advisor, my name is Keira Smith. Today, we're here at the 2023 ASH Annual meeting, and I'm joined by Dr. Evandro Bezerra, who is a Hematology Specialist at The Ohio State University Comprehensive Cancer Center. Dr. Bezerra, thank you so much for stopping by today to record this podcast.
Evandro Bezerra, MD: Thanks so much for the invitation. I'm excited to share our data.
Oncology Data Advisor: Yes, I'm excited to hear about it. To start off, would you like to introduce yourself and tell us a little bit about what you do in your work?
Dr. Bezerra: Of course. My name is Evandro Bezerra. I'm a Clinical Assistant Professor of Hematology at The Ohio State University. I mainly treat patients with lymphoid malignancies like lymphoma and leukemias that need transplant or cell therapies like chimeric antigen receptor (CAR) T-cell.
Oncology Data Advisor: Great. So, you're presenting this weekend at ASH Real-World Outcomes of Brexucabtagene Autoleucel for Relapsed or Refractory Adult B-Cell Acute Lymphoblastic Leukemia. For background, would you like to tell us a little bit about brexu-cel and how it's currently used for B-cell ALL?
Dr. Bezerra: Of course. So, brexu-cel is one of the anti-CD19 CAR T-cells with a costimulatory domain CD28. It's a CAR T-cell therapy that's approved for patients with relapsed/refractory B-cell ALL.
Oncology Data Advisor: Awesome. What did this study that you're presenting on Monday investigate?
Dr. Bezerra: So, the study they're going to present Monday showed the real-world data of brexu-cel for relapsed/refractory B-cell ALL since it received approval by the FDA and became standard-of-care. As we know, brexu-cel in the ZUMA-3 clinical trial—the pivotal trial that led to the FDA approval of brexu-cel for patients with relapsed/refractory ALL—showed high efficacy. But it's important to show the data in the real-world setting to support the similar outcomes to prove that the therapy is effective in the real-world setting. In our data, we showed that brexu-cel is highly effective in patients in the real-world setting, and the toxicity profile was manageable, consistent with what was seen in the ZUMA-3 clinical trial.
Oncology Data Advisor: Awesome. That's very exciting. So, were any of these results surprising in comparison to ZUMA-3 or other known data of brexu-cel?
Dr. Bezerra: Yes. So, one of the main findings in our data was that about 90% of the patients that were treated in the real-world setting would potentially not be eligible for the ZUMA-3 clinical trial. Despite this difference, the patient population in the real-world setting shows that brexu-cel was highly effective. Also, in the subgroup analysis looking at patients older or younger than 60 years old and patients that had prior blinatumomab, prior transplant, orextramedullary disease, we didn't see a difference in effectiveness outcomes.
Oncology Data Advisor: That's great. Since you mentioned that 90% of patients would've been ineligible for the trial, do you think this informs anything in terms of clinical trial design or eligibility criteria?
Dr. Bezerra: I think that supports the challenging of the difference of patients treated in a clinical trial, that they need to have a strict eligibility criteria to have the data generated in a clinical trial for efficacy and safety. But we always need to—after the clinical trial—have studies like the one I'm presenting, that shows the real-world data to support the external validation of the clinical trial, showing that the outcomes are consistent with what we see in the clinical trial, despite this difference in the population between a clinical trial and the real-world setting.
Oncology Data Advisor: Great. Do these data change anything in terms of practice or use of brexu-cel, or how is it important for clinicians to know this data?
Dr. Bezerra: I think first, they support the use, since the data from the clinical trial support that brexu-cel is highly effective and the toxicity profile has a similar management, consistent with Day 1, seen in the ZUMA-3 clinical trial except the patient population difference. And number two, an interesting finding, a lot of patients are getting brexu-cel in the real-world setting with lower disease burden, and in this population, brexu-cel remains highly effective.
Oncology Data Advisor: That's great to know. Anything else you'd like to mention about the presentation?
Dr. Bezerra: I'm excited to share this data of the real-world setting and show that number one, brexu-cel is effective in the real-world setting; number two, the toxicity profile was manageable and consistent to see in the ZUMA-3 clinical trial, and we didn't see any signal of difference in the effectiveness outcomes in the subgroup analysis. Especially since a lot of patients are receiving brexu-cel's lower disease burden in the clinical trial and they have favorable outcomes. All the analysis of this data with longer follow-up and larger subgroup analysis are planned by our group and going to be reported later.
Oncology Data Advisor: Great. It's so exciting to hear about the efficacy of brexu-cel in the real-world setting, and we're looking forward to hearing more at your presentation as well. Thank you so much for coming by to talk about this data.
Dr. Bezerra: Thank you.
About Dr. Bezerra
Evandro Bezzera, MD, is a Clinical Assistant Professor of Hematology and a Hematology Specialist at The Ohio State University Comprehensive Cancer Center. Dr. Bezerra's research focuses on lymphoid malignancies, including lymphomas, leukemias that need transplant, and cell therapies, such as CAR T-cell. He is an active participant in clinical research, with a passion for reporting real-world outcomes and data.
For More Information
Bezerra E, Itani T, Wudhikarn K, et al (2023). Real-world outcomes of brexucabtagene autoleucel (brexu-cel) for relapsed or refractory (R/R) adult b-cell acute lymphoblastic leukemia (B-cell ALL): evidence from the CIBMTR Registry. Presented at: 2023 American Society of Hematology Annual Meeting. Abstract 1029. Available at: https://ash.confex.com/ash/2023/webprogram/Paper177693.html
Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of Oncology Data Advisor.