Lisocabtagene Maraleucel Versus Standard of Care for Second-Line Relapsed/Refractory Large B-Cell Lymphoma: 3-Year Follow-Up From the Randomized, Phase III TRANSFORM Study
Abstract
We report 3-year follow-up results from TRANSFORM comparing lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) for second-line primary refractory/early relapsed (≤12 months) large B-cell lymphoma (LBCL). Adults eligible for autologous stem cell transplantation (N = 184) were randomly assigned 1:1 to liso-cel (100 × 10 6 chimeric antigen receptor–positive T cells) or SOC. Results are reported descriptively. With a median follow-up of 33.9 months, median (95% CI) event-free survival was 29.5 months (9.5 to not reached [NR]) for liso-cel versus 2.4 months (2.2 to 4.9) for SOC (hazard ratio [HR], 0.375; 95% CI, 0.259 to 0.542). Median progression-free survival was NR (12.6-NR) for liso-cel versus 6.2 months (4.3-8.6) for SOC (HR, 0.422; 95% CI, 0.279 to 0.639) with 36-month rates of 51% versus 26.5%. Median overall survival (OS) was NR for both arms (HR, 0.757; 95% CI, 0.481 to 1.191), with 66% of patients crossing over to receive liso-cel; 36-month OS rate was 63% for liso-cel versus 52% for SOC. OS HR (0.566 [95% CI, 0.359 to 0.895]) favored liso-cel when accounting for the treatment effect of crossover. Safety results were consistent with previous reports. At 3-year follow-up, liso-cel confirmed superior, more durable efficacy versus SOC with a favorable safety profile and no new safety signals. These data support liso-cel as an effective second-line treatment with curative potential for relapsed/refractory LBCL.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (21)
Manali Kamdar
Scott R. Solomon
Northside Hospital Cancer Institute, Atlanta, Georgia, United States
Jon Arnason
11Beth Israel Deaconess Medical Center, Boston, United States
Patrick B. Johnston
Mayo Clinic, Rochester, MN
Bertram Glass
21Department of Hematology and Cell Therapy Helios Klinikum Berlin-Buch, Berlin, Germany
Veronika Bachanova
Sami Ibrahimi
16Department of Hematology Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK
Stephan Mielke
16Karolinska University Hospital, Stockholm, Sweden
Pim Mutsaers
5Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands
Francisco Hernandez-Ilizaliturri
21Roswell Park Comprehensive Cancer Center, Buffalo, United States
Koji Izutsu
National Cancer Center Hospital, Tokyo, Japan
Franck Morschhauser
Centre Hospitalier Universitaire de Lille, Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France
Matthew Lunning
Department of Internal Medicine, Division of Oncology and Hematology, Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center and Nebraska Medicine, Omaha
Victor A. Chow
Bristol Myers Squibb, Seattle, WA
Sandrine Montheard
16Bristol Myers Squibb, Boudry, Switzerland
Josu Santamaria
5Incyte Corporation, Wilmington, United States
Silvia Colicino
Bristol Myers Squibb, Boudry, Switzerland
Ken Ogasawara
Bristol Myers Squibb, Princeton, New Jersey, United States
Lara Stepan
1Bristol Myers Squibb, Seattle, United States
Fei Fei Liu
19Bristol Myers Squibb, Princeton, NJ
Jeremy S. Abramson
1Department of Medical Oncology, Massachusetts General Hospital, Boston, MA