OUTCOMES WITH KTE-X19 IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA IN ZUMA-2 WHO HAD PROGRESSION OF DISEASE WITHIN 24 MONTHS OF DIAGNOSIS
Author(s): ,
Michael L. Wang, MD
Affiliations:
The University of Texas MD Anderson Cancer Center,Houston, TX,United States
,
Javier Munoz, MD, MS, FACP
Affiliations:
Banner MD Anderson Cancer Center,Gilbert, AZ,United States
,
Andre Goy, MD
Affiliations:
John Theurer Cancer Center,Hackensack, NJ,United States
,
Frederick L. Locke, MD
Affiliations:
Moffitt Cancer Center,Tampa, FL,United States
,
Caron A. Jacobson, MD, MMSc
Affiliations:
Dana-Farber Cancer Institute,Boston, MA,United States
,
Brian T. Hill, MD, PhD
Affiliations:
Cleveland Clinic Foundation,Cleveland, OH,United States
,
John M. Timmerman, MD
Affiliations:
UCLA David Geffen School of Medicine,Los Angeles, CA,United States
,
Houston Holmes, MD, MBA, FACP
Affiliations:
Texas Oncology,Dallas, TX,United States
,
Samantha Jaglowski, MD
Affiliations:
The Ohio State University Comprehensive Cancer Center,Columbus, OH,United States
,
Ian W. Flinn, MD, PhD
Affiliations:
Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN,United States
,
Peter A. McSweeney, MB, ChB
Affiliations:
Colorado Blood Cancer Institute,Denver, CO,United States
,
David B. Miklos, MD, PhD
Affiliations:
Stanford University School of Medicine,Stanford, CA,United States
,
Marie José Kersten, MD, PhD
Affiliations:
Amsterdam UMC, University of Amsterdam, on behalf of HOVON/LLPC,Amsterdam,Netherlands
,
Krimo Bouabdallah, MD
Affiliations:
CHU Bordeaux, Service d’hématologie et thérapie Cellulaire,Bordeaux,France
,
Max S. Topp, MD
Affiliations:
Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg,Würzburg,Germany
,
Rhine Shen, PhD
Affiliations:
Kite, a Gilead Company,Santa Monica, CA,United States
,
Ioana Kloos, MD
Affiliations:
Kite, a Gilead Company,Santa Monica, CA,United States
,
Weimin Peng, PhD
Affiliations:
Kite, a Gilead Company,Santa Monica, CA,United States
,
Xiang Fang, PhD
Affiliations:
Kite, a Gilead Company,Santa Monica, CA,United States
Patrick M. Reagan, MD
Affiliations:
University of Rochester Medical Center,Rochester, NY,United States
EHA Library. Wang M. 06/09/21; 325545; EP787
Michael L. Wang
Michael L. Wang
Contributions
Abstract
Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP787

Type: E-Poster Presentation

Session title: Indolent and mantle-cell non-Hodgkin lymphoma - Clinical

Background
KTE-X19 is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved in the United States and European Union for the treatment of relapsed/refractory mantle cell lymphoma (MCL). In the ZUMA-2 study in which KTE-X19 was evaluated in relapsed/refractory MCL, the objective response rate at a median 17.5-month follow-up period was 92% (67% complete response rate; Blood. 2020;136[suppl, abstr]:20-22).

Aims
To report results in patients with or without progression of disease within 24 months of diagnosis (POD24), an indicator of poor outcomes (Br J Haematol. 2019;185:940-944).

Methods
Eligible patients with relapsed/refractory MCL underwent leukapheresis and conditioning chemotherapy followed by a single infusion of KTE-X19. Efficacy results are reported for the 60 treated patients with ≥1 year of follow-up (median, 17.5 months), and safety results are presented for all 68 treated patients.

Results
High-risk disease characteristics were common in patients with (n=33) and without POD24 (n=35), although patients with POD24 had higher tumor burden and lactate dehydrogenase levels, and more had blastoid-type MCL (Table). The objective response rate in patients with (n=28) and without POD24 (n=32) was 93% and 91%, with complete response rates of 61% and 72%, respectively. In patients with and without POD24, median progression-free survival was 11.3 months (range, 0.9–30.3) and 29.3 months (range, 0–35.9), respectively. Medians for duration of response and overall survival were not reached in either group.

 


Most common Grade ≥3 adverse events in patients with versus without POD24 were neutropenia (91% vs 80%), thrombocytopenia (61% vs 46%), and anemia (55% vs 51%); Grade ≥3 cytokine release syndrome and neurologic events occurred in 9% versus 20% and 27% versus 34%, respectively. There were no cases of Grade 5 cytokine release syndrome, KTE-X19–related secondary cancers, or replication-competent retrovirus in either group.


 


In patients with versus without POD24, median peak CAR T-cell levels and median area under the curve were 53.4 cells/mL (range, 0.2–2566) and 583.4 cells/mL (range, 1.8–27,743.6) versus 112.4 cells/mL (range, 0.2–2589) and 1588.3 cells/mL (range, 3.8–27,238.7), respectively; by 12 months, B cells were detectable in 8/11 (73%) vs 7/15 patients (47%) in ongoing response.

Conclusion
KTE-X19 provided a high complete response rate across all patients, with the medians for duration of response and overall survival not reached. Patients with POD24 had more aggressive high-risk disease characteristics (tumor burden, lactate dehydrogenase levels, and blastoid-type MCL) and generally lower CAR T-cell expansion and progression-free survival versus patients without POD24. Earlier intervention with CD19-directed CAR T-cell therapy may benefit patients with MCL with known high-risk factors.

Keyword(s): CAR-T, Clinical trial, High risk, Mantle cell lymphoma

Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP787

Type: E-Poster Presentation

Session title: Indolent and mantle-cell non-Hodgkin lymphoma - Clinical

Background
KTE-X19 is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved in the United States and European Union for the treatment of relapsed/refractory mantle cell lymphoma (MCL). In the ZUMA-2 study in which KTE-X19 was evaluated in relapsed/refractory MCL, the objective response rate at a median 17.5-month follow-up period was 92% (67% complete response rate; Blood. 2020;136[suppl, abstr]:20-22).

Aims
To report results in patients with or without progression of disease within 24 months of diagnosis (POD24), an indicator of poor outcomes (Br J Haematol. 2019;185:940-944).

Methods
Eligible patients with relapsed/refractory MCL underwent leukapheresis and conditioning chemotherapy followed by a single infusion of KTE-X19. Efficacy results are reported for the 60 treated patients with ≥1 year of follow-up (median, 17.5 months), and safety results are presented for all 68 treated patients.

Results
High-risk disease characteristics were common in patients with (n=33) and without POD24 (n=35), although patients with POD24 had higher tumor burden and lactate dehydrogenase levels, and more had blastoid-type MCL (Table). The objective response rate in patients with (n=28) and without POD24 (n=32) was 93% and 91%, with complete response rates of 61% and 72%, respectively. In patients with and without POD24, median progression-free survival was 11.3 months (range, 0.9–30.3) and 29.3 months (range, 0–35.9), respectively. Medians for duration of response and overall survival were not reached in either group.

 


Most common Grade ≥3 adverse events in patients with versus without POD24 were neutropenia (91% vs 80%), thrombocytopenia (61% vs 46%), and anemia (55% vs 51%); Grade ≥3 cytokine release syndrome and neurologic events occurred in 9% versus 20% and 27% versus 34%, respectively. There were no cases of Grade 5 cytokine release syndrome, KTE-X19–related secondary cancers, or replication-competent retrovirus in either group.


 


In patients with versus without POD24, median peak CAR T-cell levels and median area under the curve were 53.4 cells/mL (range, 0.2–2566) and 583.4 cells/mL (range, 1.8–27,743.6) versus 112.4 cells/mL (range, 0.2–2589) and 1588.3 cells/mL (range, 3.8–27,238.7), respectively; by 12 months, B cells were detectable in 8/11 (73%) vs 7/15 patients (47%) in ongoing response.

Conclusion
KTE-X19 provided a high complete response rate across all patients, with the medians for duration of response and overall survival not reached. Patients with POD24 had more aggressive high-risk disease characteristics (tumor burden, lactate dehydrogenase levels, and blastoid-type MCL) and generally lower CAR T-cell expansion and progression-free survival versus patients without POD24. Earlier intervention with CD19-directed CAR T-cell therapy may benefit patients with MCL with known high-risk factors.

Keyword(s): CAR-T, Clinical trial, High risk, Mantle cell lymphoma

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