Lisocabtagene maraleucel combined with ibrutinib in R/R CLL or SLL: primary results from TRANSCEND CLL 004
Abstract
Patients in the liso-cel plus ibrutinib cohort of the phase 1/2, open-label TRANSCEND CLL 004 study had relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and received liso-cel (50×106 [dose level (DL)1] or 100×106 [DL2] chimeric antigen receptor-positive T cells) with concurrent ibrutinib from enrollment through 90 days after liso-cel infusion or longer per investigator discretion. Primary end point was complete response/remission (CR)/CR with incomplete marrow recovery (CRi) by investigator assessment. Among 56 patients who received ibrutinib plus liso-cel (DL1, n=5; DL2, n=51), median (range) age was 64.5 years (44‒77), 98% had high-risk cytogenetics, 55% had progression on Bruton tyrosine kinase inhibitor and venetoclax failure, and median (range) number of prior therapies was 5 (1‒13). Median (range) follow-up was 24.8 months (3.1‒51.8). At DL2, CR/CRi rate was 45% (95% confidence interval [CI], 31‒60) and overall response rate was 86% (95% CI, 74‒94). Median (95% CI) duration of response was not reached (NR; 28.7‒NR) for patients with CR/CRi and 41.4 months (23.3‒NR) for all responders. Median (95% CI) progression-free survival was 31.4 months (20.1‒NR). In DL1+DL2, most common grade ≥3 treatment-emergent adverse events (TEAE) were neutropenia (52%) and anemia (41%). Cytokine release syndrome was reported in 80% of patients (grade 3, 4%; no grade 4/5), and neurological events in 41% (grade 3/4, 11%; no grade 5). Ibrutinib-related TEAEs were reported in 68% of patients (grade 3/4, 43%; no grade 5). Liso-cel plus ibrutinib demonstrated notable efficacy in patients with relapsed/refractory CLL/SLL with predictable and manageable safety. Clinicaltrials.gov: NCT03331198; NCT03435796.
Article Details
Authors (39)
William G. Wierda
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Kathleen A Dorritie
UPMC, Pittsburgh, Pennsylvania, United States
Jordan Gauthier
Rajneesh Nath
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Thomas J. Kipps
University of California, San Diego School of Medicine, La Jolla, California, United States
Peter A. Riedell
Herbert A. Eradat
UCLA, Los Angeles, California, United States
Saad S. Kenderian
Mohamed A. Kharfan-Dabaja
Mayo Clinic, Jacksonville, Florida, United States
Nirav N Shah
Medical College of Wisconsin, Wauwatosa, Wisconsin, United States
Scott R. Solomon
Northside Hospital Cancer Institute, Atlanta, Georgia, United States
Deborah M. Stephens
Daniel A. Ermann
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States
Jon E. Arnason
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Abhinav Deol
Wayne State University, Detroit, Michigan, United States
Tatyana A. Feldman
Hackensack University Medical Center, Hackensack, New Jersey, United States
Charalambos Babis Andreadis
University of California San Francisco, San Francisco, California, United States
Monalisa Ghosh
Shuo Ma
Stephen J. Schuster
Lymphoma Program, Abramson Cancer Center, Division of Hematology Oncology, Department of Medicine, University of Pennsylvania
Usama Gergis
Thomas Jefferson University, philadelphia, Pennsylvania, United States
Julie M. Vose
Jacob D Soumerai
Mass General Brigham Cancer Institute, Boston, Massachusetts, United States
Koen van Besien
Seidman Cancer Center, Cleveland, Ohio, United States
Sherilyn A. Tuazon
Bristol Myers Squibb, Seattle, Washington, United States
Serena K. Perna
Bristol Myers Squibb, Princeton, New Jersey, United States
San-San Ou
Bristol Myers Squibb, Seattle, Washington, United States
Revathi Ananthakrishnan
Bristol Myers Squibb, Princeton, New Jersey, United States
Neha Rane
Bristol Myers Squibb, Princeton, New Jersey, United States
Eniko Papp
Sahar Ansari
Bristol Myers Squibb, Seattle, Washington, United States
Ethan G. Thompson
Bristol Myers Squibb, Seattle, Washington, United States
Abood Okal
Bristol Myers Squibb, Cambridge, Massachusetts, United States
Leanne Peiser
Immuno-Oncology Cellular Therapy Thematic Research Center, Bristol Myers Squibb
Yizhe Chen
Department of Chemistry
Sanhita Sengupta
Bristol Myers Squibb, Princeton, New Jersey, United States
Pradipta Ranjan Ray
Bristol Myers Squibb, Summit, New Jersey, United States
Jixian Wang
State Key Laboratory of Medicinal Chemical biology College of Chemistry Nankai University Tianjin 300071 China
Tanya Siddiqi
City of Hope Orange County, Irvine, California, United States