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On Saturday 1st December 2018, an oral abstract session took place at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, CA. During Session 627 (Aggressive lymphoma - results from retrospective/observational studies: outcomes with CD-19 CAR‑T therapy and checkpoint blockade in the real world setting) Abstract 91 was presented by Loretta J. Nastoupil, University of Texas MD Anderson Cancer Center, Houston, TX.
The study evaluated the real-world outcomes of patients treated with standard of care axicabtagene ciloleucel (axi-cel) under the commercial Food and Drug Administration (FDA) label. Data from 17 US academic centers were retrospectively analyzed.
All patients leukapheresed as of 31st August 2018 (N = 295), with the intention to manufacture commercial axi-cel, were included in the analysis. Of the 295 patients, 274 patients received conditioning chemotherapy and were infused with axi-cel. Median time from leukapheresis to start of conditioning chemotherapy was 21.5 days. Of the 21/295 patients who were not infused with axi‑cel: 7 patients went on to receive axi-cel therapy on the ZUMA-9 expanded access trial (NCT03153462) due to non-conforming cell therapy product, 12 patients died secondary to lymphoma, 1 patient had non-measurable disease, and 1 patient experienced infection.
Median age was 60 years (range 21–83) with 96 (33%) patients aged ≥ 65 years old and 65% of patients were male. Performance status (PS) was ECOG 0–1 (81%), ECOG 2 (15%) and ECOG 3–4 (4%). By histology, 68% of patients had diffuse large B-cell lymphoma (DLBCL), 26% had transformed follicular lymphoma (tFL), and 6% had primary mediastinal B-cell lymphoma (PMBCL). Seventy-five percent of patients had received > 3 prior therapies, 35% of patients were primary refractory, 42% of patients were refractory to second line or later, and 33% of patients had relapsed post-autologous stem cell transplant (ASCT).
Bridging therapy between apheresis and infusion was given in 158 (55%) patients, the majority of which consisted of chemotherapy. In total, 43% of patients in this analysis would not have met the eligibility criteria for the ZUMA-1 study at the time of leukapheresis. Common criteria that would have made these patients ineligible for ZUMA-1 included platelets < 75 (n = 13), active deep vein thrombosis/pulmonary embolism (n = 9), prior CD-19 or CAR-T therapy (n = 8), glomerular filtration rate < 60 (n = 8), a history of CNS lymphoma (n = 8), symptomatic pleural effusion (n = 4), left ventricular ejection fraction < 50% (n = 4) and prior allogeneic transplant (n = 2).
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