Bergisch Gladbach, October 27, 2026 – Today, Miltenyi Biomedicine announced that results from the phase II DALY 2-EU study of investigational therapy zamtocabtagene autoleucel (zamto-cel) in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) not eligible for high-dose chemotherapy with autologous stem cell transplantation (ASCT) were published in The Lancet Oncology. DALY 2-EU met its primary endpoint, demonstrating a statistically significant improvement in event-free survival (EFS) with zamto-cel compared with chemoimmunotherapy regimen rituximab, gemcitabine and oxaliplatin (R-GemOx).

"The prospectively randomized DALY 2-EU study demonstrates a hazard ratio of 0.39 for event-free survival with zamto-cel versus standard chemoimmunotherapy, alongside a manageable safety profile. This favorable benefit-risk balance represents a clinically meaningful advance for the older and more comorbid patients enrolled in the study," said Prof. Peter Borchmann, Department of Internal Medicine I, University Hospital Cologne, and principal investigator of the DALY 2-EU study.

The primary analysis included 160 patients across 45 centers in 12 European countries, reflecting the real-world profile of this population: median age of 74 years with an International Prognostic Index (IPI) score of 3-5 in 57.5% of patients.¹ No bridging chemotherapy was permitted in the zamto-cel arm; only corticosteroids were allowed.¹ At a median follow-up of 17 months, patients receiving zamto-cel achieved a median EFS of 6.21 months compared with 2.53 months for those receiving R-GemOx (HR = 0.39; 95% CI: 0.27–0.58; p < 0.0001).¹ The EFS benefit was consistent across key subgroups.¹ The best overall complete response rate among evaluable patients in the mFAS* was 60.3% with zamto-cel versus 15.4% with R-GemOx; among all randomized patients, the corresponding rates were 53.7% and 14.1%, respectively.¹

Overall in the study, zamto-cel was well-tolerated. Severe immune-mediated adverse events were uncommon with cytokine release syndrome (CRS) of grade ≥ 3 occurring in 5.3% of zamto-cel-treated patients, and neurotoxicity (ICANS) of grade ≥ 3 in 1.3%.¹ Zamto-cel was manufactured fresh using a standardized 12-day process and administered without cryopreservation, with a median vein-to-vein time from cell collection to reinfusion of 15 days.¹

In May 2026, Miltenyi Biomedicine submitted a Marketing Authorization Application (MAA) for zamto-cel to the European Medicines Agency (EMA) and in parallel to Swissmedic in Switzerland. Regulatory filings for zamto-cel are also in preparation for the U.S. Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

About zamto-cel
Zamto-cel is an investigational autologous chimeric antigen receptor (CAR) T-cell therapy designed to target both CD20 and CD19. It is being studied in clinical trials for the treatment of relapsed or refractory B-cell malignancies, including large B-cell lymphoma (LBCL), diffuse large B-cell lymphoma (DLBCL), primary and secondary central nervous system (CNS) lymphoma, mantle cell lymphoma (MCL), Richter’s transformation (RT), and other B-cell neoplasms.
Zamto-cel is manufactured using Miltenyi Biotec’s proprietary platform, CliniMACS Prodigy®, a closed, automated system. The manufacturing time of 12 days results in a median vein-to-vein time of 15 days, increasing the ability to receive cellular therapy for high-risk patients with urgent therapeutic needs. Its non-cryopreserved formulation eliminates cryopreservation-related logistical steps and costs.

About relapsed or refractory large B-cell lymphoma (r/r LBCL)
Large B-cell lymphoma (LBCL) is an aggressive non-Hodgkin lymphoma, accounting for approximately one-third of all lymphoma diagnoses in adults, with an estimated 28,000 new cases per year in Europe.² Up to 40% of patients fail first-line therapy,³ and more than half of those are not eligible for high-dose chemotherapy with autologous stem cell transplantation (ASCT).⁴ Due to the aggressive disease course, rapid and effective treatment is critical. For this population, prospective randomized data with CAR-T therapy had been lacking,¹ representing a significant unmet medical need.

About DALY 2-EU
DALY 2-EU (NCT04844866) is a randomized, open-label, multicenter phase II study conducted at 45 centers across 12 European countries. A total of 168 patients were randomized, of whom 160 were included in the primary analysis population (zamto-cel, n=82; R GemOx, n=78). Eligible patients were adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) who were unable to undergo high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to age, comorbidities, or reduced performance status.¹
The study population reflected the real-world profile of this group: median age of 74 years, 57.5% with an IPI score of 3–5, 25.6% with ECOG PS 2, and 55.6% with refractory disease. This population represents a substantial proportion of r/r LBCL cases in clinical practice for whom no robust randomized CAR-T data had previously been available.¹

About Miltenyi Biomedicine
Miltenyi Biomedicine is committed to making next-generation cancer treatments and regenerative therapies accessible to patients with serious diseases. Leveraging cutting-edge technology, the company innovates independently to address hard-to-treat blood cancers and harness the potential of CAR technology to transform patient care. As the biopharmaceutical subsidiary of the Miltenyi group, it draws on decades of experience in cell processing and GMP manufacturing. Founded in 1989, Miltenyi Biotec employs more than 4,500 people across 28 locations globally and is a leading provider of technologies and services for cell separation, cell analysis, and cell and gene therapies.

Media contact
Miltenyi Biomedicine
Friedrich-Ebert-Strasse 68
51429 Bergisch Gladbach, Germany
[email protected]

References

1. Borchmann P et al. The Lancet Oncology. 2026;27:1403–1419.
2. Thieblemont C, Gomes Da Silva M, Leppä S, et al. Large B-cell lymphoma (LBCL): EHA Clinical Practice Guidelines for diagnosis, treatment, and follow-up. HemaSphere. 2025;9:e70207. doi: 10.1002/hem3.70207.
3. Sehn LH et al. Longo DL, ed. N Engl J Med. 2021;384(9):842-858.
4. Westin J et al. Blood. 2022;139(18):2737-2746.

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