Real-world evidence of axicabtagene ciloleucel (Axi-cel) for the treatment of large B-cell lymphoma (LBCL) in the United States (US).

Authors

null

Caron A. Jacobson

Dana-Farber Cancer Institute, Boston, MA

Caron A. Jacobson , Frederick Lundry Locke , Zhen-Huan Hu , Tanya Siddiqi , Sairah Ahmed , Armin Ghobadi , David Bernard Miklos , Yi Lin , Miguel-Angel Perales , Matthew Alexander Lunning , Megan Herr , Brian T. Hill , Siddhartha Ganguly , Hua Dong , Sarah Nikiforow , Jing Xie , Hairong Xu , Michele Hooper , Jun Kawashima , Marcelo C. Pasquini

Organizations

Dana-Farber Cancer Institute, Boston, MA, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, Medical College of Wisconsin/Center for International Blood and Marrow Transplant Research, Milwaukee, WI, City of Hope National Medical Center, Duarte, CA, The University of Texas MD Anderson Cancer Center, Department of Lymphoma/Myeloma, Houston, TX, Washington University School of Medicine, St. Louis, MO, Stanford University School of Medicine, Stanford, CA, Division of Hematology, Mayo Clinic, Rochester, MN, Memorial Sloan Kettering Cancer Center, New York, NY, University of Nebraska Medical Center, Omaha, NE, Roswell Park Comprehensive Cancer Center, Buffalo, NY, Cleveland Clinic Foundation, Cleveland, OH, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, KS, Gilead Sciences, Inc., Foster City, CA, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, Kite Pharma, Santa Monica, CA, Gilead, Santa Monica, CA, Gilead Sci Inc, San Ramon, CA, Medical College of Wisconsin, Milwaukee, WI

Research Funding

U.S. National Institutes of Health
U.S. National Institutes of Health, Pharmaceutical/Biotech Company

Background: Axi-cel is approved in the US for the treatment of adult patients with relapsed or refractory LBCL after 2 or more lines of systemic therapy. Post-market long term follow up study of commercial Axi-cel recipients using the Center for International Blood and Marrow Transplant Research was recently completed. Methods: From October 2017 to August 2020, 1,500 Axi-cel recipients from 79 centers were enrolled. Of these, 1001 patients with at least 6 months of follow-up were included in this analysis. Outcomes include complete and overall responses rates (CR and ORR), duration of response (DOR), progression-free and overall survival (PFS and OS), cytokine release syndrome (CRS) (Lee D 2014 and American Society for Transplantation and Cellular Therapy [ASTCT]), immune effector cell associated neurotoxicity syndrome (ICANS), hematologic recovery and subsequent neoplasm (SN). Subgroup analysis by sensitivity to therapy, defined as responsive to the last line of therapy prior to Axi-cel. Median follow-up was 12 months (range, 6-28 months). Results: The median age overall was 62 years, 37% were ≥ 65 years, 83% with Eastern Cooperative Oncology Group (ECOG) performance score 0-1, 28% with transformed lymphoma, 14% with high grade lymphoma, 29% with prior autologous transplant, and 66% with chemotherapy-resistant disease prior to Axi-cel. The median time from diagnosis to Axi-cel infusion was 15 months. Best ORR was 70% (CR 53%). Landmark analysis of patients in CR at 6 months post Axi-cel demonstrates a low number of subsequent progression/death events. With respect to outcomes for chemotherapy-sensitive disease versus resistant disease, the ORR, CR, 12-month PFS and OS were 78% vs. 66%, 60% vs. 48%, 55% (95% CI, 48-62%) vs. 40% (95% CI, 37-44%), and 70% (95% CI, 63-76%) vs. 54% (95% CI, 50-58%), respectively. CRS of any grade was reported in 83% of patients. Incidence of Grades ≥ 3 CRS was 10% according to Lee et al 2014, and 13% according to ASTCT Consensus Grading. Median time to any grade CRS was 4 days (range, 1-28 days), and 93% of CRS cases resolved with a median duration of 7 days (range, 1-121 days). ICANS were reported in 576 (57%) patients, grade >3 was 26%. The median time to onset of ICANS was 7 days (range, 1-82 days), and 86% resolved with a median duration of 9 days (range, 1 to 115 days). Twenty-nine patients (2.9%) reported SN: hematologic (N = 17), solid tumors (N = 12). Conclusions: This is the largest report on Axi-cel in the real-world setting and demonstrates consistent efficacy outcomes and further characterizes safety outcomes. Patients in CR at 6 months have sustained disease control with low number of relapse events. Although patients with therapy-sensitive disease experience better outcomes than patients with therapy-resistant, the overall outcomes on both groups of patients are favorable.

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies

Sub Track

Non-Hodgkin Lymphoma

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 7552)

DOI

10.1200/JCO.2021.39.15_suppl.7552

Abstract #

7552

Poster Bd #

Online Only

Abstract Disclosures