Miltenyi Biomedicine presents primary analysis of the pivotal DALY 2-EU trial for second-line relapsed/refractory large B-cell lymphoma at the 67th American Society of Hematology (ASH) Annual Meeting
Miltenyi Biomedicine presents primary analysis of the pivotal DALY 2-EU trial for second-line relapsed/refractory large B-cell lymphoma at the 67th American Society of Hematology (ASH) Annual Meeting Leave a reply DALY 2-EU results show zamtocabtagene autoleucel (zamto-cel) demonstrated clinically meaningful superiority over chemoimmunotherapy in patients with relapsed/refractory large B-cell lymphoma (r/r LBCL)1 Zamto-cel was well-tolerated in the majority of patients. DALY 2-EU included a high-risk study population, characterized by older age and clinically high-risk disease features A 12-day manufacturing time resulted in a vein-to-vein time of 14-16 days, reducing the likelihood for bridging therapy. BERGISCH GLADBACH, Germany, Dec. 07, 2025 (GLOBE NEWSWIRE) — Miltenyi Biomedicine today announced results from the pivotal DALY 2-EU trial evaluating the efficacy and safety of zamtocabtagene autoleucel (zamto-cel) compared with standard chemoimmunotherapy (R-GemOx or Pola-BR) in patients with second-line, relapsed or refractory large B-cell lymphoma (r/r LBCL) who were transplant-ineligible due to age, comorbidities, or other medical reasons. The primary analysis showed that zamto-cel demonstrated significant and clinically meaningful superiority over chemoimmunotherapy (R-GemOx) in transplant-ineligible patients who were at a high risk of rapid disease progression.1 This study population was characterized by older age and clinically high-risk disease features: the median age was 74 years, 57% of patients had a high International Prognostic Index (IPI≥ 3) and 67% presented with stage III/IV disease. Zamto-cel was well tolerated in this predominantly older and high-risk population.1 Dr. Peter Borchmann, Lead investigator of DALY 2-EU trial and Assistant Medical Director in the Department of Hematology and Oncology at the University Hospital of Cologne, Germany, said: “Zamto-cel demonstrated clinically meaningful and statistically significant superiority over R-GemOx in transplant-ineligible patients with high-risk disease, improving event-free survival while maintaining a favorable tolerability profile. These findings highlight the potential of zamto-cel as an important new treatment option for a clinically vulnerable patient population with