Glofitamab Combined With Pola-R-CHP or R-CHOP as First Therapy in Younger Patients With High-Risk Large B-Cell Lymphoma: Results From the COALITION Study
- Author(s)
- Minson, A; Verner, E; Giri, P; Butler, J; Janowski, W; Cheah, CY; Ratnasingam, S; Wong, SM; Ku, M; Hertzberg, M; Herbert, K; Hamad, N; Yannakou, CK; Swain, F; Neeson, P; Steiner, TM; Saghebi, J; Blombery, P; Hunter, SM; Robertson, M; Lau, LS; Bennett, R; Harrop, S; Xie, J; Seymour, JF; Dickinson, MJ;
- Journal Title
- Journal of Clinical Oncology
- Publication Type
- Online publication before print
- Abstract
- PURPOSE: Improved outcomes are needed for patients with high-risk (HR) large B-cell lymphoma (LBCL) who have <50% chance of cure with first-line (1L) R-CHOP chemotherapy. Patients with high burden or rapid progression are often excluded from 1L trials due to screening requirements. We report the investigator-initiated, phase II COALITION trial of the CD20xCD3 bispecific antibody glofitamab combined with R-CHOP or Pola-R-CHP in younger patients with HR features, designed to minimize time between diagnosis and treatment. METHODS: Patients age ≤65 years with LBCL and at least one HR feature (international prognostic index [IPI] ≥3, National Comprehensive Cancer Network-IPI ≥4, or rearrangements of MYC and BCL2 and/or BCL6) received one cycle of R-CHOP and were randomly assigned to five cycles of Glofit-Pola-R-CHP (n = 40) or Glofit-R-CHOP (n = 40), and two cycles of glofitamab consolidation. Enrollment occurred before or after a cycle of R-CHOP. The primary objective was safety and treatment deliverability. Secondary end points included response rates and survival. RESULTS: Eighty evaluable patients with a median age of 58 years and total metabolic tumor volume of 842 cm(3) were included and began treatment a median of 14 days from diagnosis. Over 95% of patients completed all therapy and the median relative dose intensity was >94%. Cytokine release syndrome was observed in 21% of patients, all ≤grade 2 and manageable. Overall and complete response rates were 100% and 98%, respectively. At 20.7-month median follow-up, the estimated 2-year progression-free survival and overall survival were 86% and 92%, respectively. CONCLUSION: The combination of glofitamab with R-CHOP or Pola-R-CHP is deliverable and results in high rates of durable response in this population of younger patients with high-burden, HR LBCL, supporting its ongoing exploration as a 1L treatment.
- Department(s)
- Haematology; Laboratory Research; Cancer Imaging; Pathology; Parkville Cancer Clinical Trials Unit
- Publisher's Version
- https://doi.org/10.1200/jco-25-00481
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2025-07-31 04:18:49
Last Modified: 2025-07-31 04:18:59