Jay Spiegel, MD, FRCPC, on 5-Year Real-World Outcomes From Axi-cel in R/R LBCL

“I think we were really reassured that it performed similarly to the clinical trial, even in this real-world setting.”

Kite Pharma’s chimeric antigen receptor T-cell (CAR-T) therapy axicabtagene ciloleucel (axi-cel; Yescarta) was originally approved by the FDA in October 2017 for the treatment of patients with diffuse large B-cell lymphoma (LBCL) whose disease was relapsed/refractory (r/r) to at least 2 previous other types of therapy.¹ The decision was based on data from the pivotal phase 1/2 ZUMA-1 clinical trial (NCT02348216). Shortly after this approval, real-world treatment of patients with axi-cel as a standard of care option began in centers of excellence in the United States.²

Long-term real-world outcomes data from some patients treated in the year after approval at the 17 academic centers that compose the US Lymphoma CAR-T Consortium have been collected over the past 5 years. These 5-year outcomes data were recently presented by Jay Spiegel, MD, FRCPC, a hematologist and cell therapist from the University of Miami Sylvester Comprehensive Cancer Center, at the 2023 American Society of Hematology (ASH) Annual Meeting & Exposition, held December 9-12, in San Diego, California.

In an interview with CGTLive™ at the conference, Spiegel discussed the key takeaways of the data he presented. He noted that it was encouraging to see that the real-world outcomes were similar to those of the ZUMA-1 clinical trial in terms of end points like overall survival and progression-free survival. On the other hand, he noted that some disappointing survivorship outcomes in the real-world data, such as 16.5% for nonrelapse mortality, will require further investigation to determine their cause. Beyond discussing the data he presented, Spiegel also spoke about future plans for further study, lessons learned from treating patients with CAR-T in his center, other data he is excited to see at ASH’s 2023 conference, and big trends in the field in 2023.

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REFERENCES
1. FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma. News release. FDA. October 18, 2017. Accessed December 12, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-car-t-cell-therapy-treat-adults-certain-types-large-b-cell-lymphoma
2. Spiegel JY, Jain MD,Nastoupil LJ, et al.Five year outcomes of patients with large B-cell lymphoma treated with standard-of-careaxicabtageneciloleucel: results from the US lymphoma CAR-T cell consortium. Presented at: ASH 2023 Annual Meeting & Exposition. December 9-12; San Diego, CA. Abstract #1032