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
Adrian Minson, Emma Verner, Pratyush Giri, Jason M. Butler, Wojciech Janowski, Chan Y. Cheah, Sumita Ratnasingam, Shu Min Wong, Matthew Ku, Mark P. Hertzberg, Kirsten Herbert, Nada Hamad, Costas K. Yannakou, Fiona Swain, Paul J. Neeson, Thiago M. Steiner, Javad Saghebi, Piers Blombery, Sally M. Hunter, Molly Robertson, Lei Shong Lau, Rory Bennett, Sean Harrop, Jing Xie, John F. Seymour, Michael Dickinson
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: ) 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: 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.