Five Year Outcomes of Patients with Large B-Cell Lymphoma Treated with Standard-of-Care Axicabtagene Ciloleucel: Results from the US Lymphoma CAR-T Cell Consortium

Introduction Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 Chimeric Antigen Receptor (CAR) T-cell therapy that induces durable responses in patients with relapsed or refractory large B-cell lymphoma. At a median of 63.1 months follow-up on the ZUMA-1 trial, median overall survival (OS...

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Published in:Blood 2023-11, Vol.142 (Supplement 1), p.1032-1032
Main Authors: Spiegel, Jay Y., Jain, Michael D., Nastoupil, Loretta J., Tamaresis, John, Ghobadi, Armin, Lin, Yi, Lekakis, Lazaros J., Reagan, Patrick M., Oluwole, Olalekan O., McGuirk, Joseph P, Deol, Abhinav, Dorritie, Kathleen, Sehgal, Alison R, Goy, Andre, Hill, Brian T., Andreadis, Charalambos, Munoz, Javier L., Ulrickson, Matthew L., Westin, Jason, Chavez, Julio C., Patel, Dilan A, Jacobs, Miriam T., Bansal, Radhika, Bennani, N. Nora, Patel, Vivek, Rapoport, Aaron P., Vose, Julie M., Miklos, David B., Neelapu, Sattva S., Locke, Frederick L., Lunning, Matthew A, Dahiya, Saurabh
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Language:English
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Summary:Introduction Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 Chimeric Antigen Receptor (CAR) T-cell therapy that induces durable responses in patients with relapsed or refractory large B-cell lymphoma. At a median of 63.1 months follow-up on the ZUMA-1 trial, median overall survival (OS) was 25.8 months with 5-year OS and PFS (progression-free survival) estimates of 42.6% (95% CI, 32.8-51.9) and 31.8% (95% CI, 22.9-41.1), respectively (Neelapu, Blood 2023). We previously reported outcomes of axi-cel patients treated with standard of care therapy, including 42% who did not meet eligibility criteria for ZUMA-1 based on co-morbidities (Nastoupil, JCO 2020). Here we report results from this cohort at a median follow up of 58 months, as well as late outcomes of interest. Results The US Lymphoma CAR-T Consortium is comprised of 17 US academic centers who contributed data independent of the manufacturer. Two hundred and ninety-eight patients underwent leukapheresis with intent to manufacture standard of care axi-cel (n=298) as of September 30, 2018. In infused patients (n=275), OS and PFS were calculated from date of infusion. After a median follow-up of 58 months, median OS was 34.9 months (95% CI 23.4 - 44.8) with the OS at 3, 4, and 5 years of 49.1% (95% CI 42.9 - 54.9%), 43% (95% CI 36.8 - 48.9%), and 40.3% (95% CI 34.2 - 46.4%), respectively. The median PFS was 8.7 months (95% CI 5.87 - 16.6) and the 3-,4-, and 5- year PFS were 36.1% (95% CI 30.4 - 41.8%), 30.7 (95% CI 25.2 - 36.4%), and 28.5% (95% CI 23 - 34.2%), respectively. Results of multi-variable modeling were similar to our prior analysis: male sex (HR 1.56, 95% CI 1.08 - 2.27, p =0.02); LDH above the upper limit of normal (HR 1.6, 95% CI 1.12 - 2.30, p = 0.01); ECOG status of 2-4 (HR 2.02, 95% CI 1.33 - 3.07, p = 1.5 (HR 5.68, 95% CI 2.21 - 14.6, p =
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2023-179868