Miltenyi Biomedicine's Zamto-cel Outperforms Chemoimmunotherapy In Pivotal Lymphoma Trial

KUALA LUMPUR, Dec 8 (Bernama) -- Miltenyi Biomedicine, a clinical-stage biopharmaceutical company, reported pivotal results from the DALY 2-EU Phase II trial evaluating its CAR-T therapy zamtocabtagene autoleucel (zamto-cel) in transplant-ineligible patients with second-line relapsed or refractory large B-cell lymphoma.

Announced at the 67th American Society of Hematology Annual Meeting, the trial demonstrated that zamto-cel delivered significantly longer event-free and progression-free survival compared with chemoimmunotherapy (R-GemOx). The therapy also achieved higher overall and complete response rates.

Miltenyi Biomedicine Chief Executive Officer, Dr Toon Overstijns in a statement said the findings mark a major milestone in advancing cell and gene therapies, noting that zamto-cel — the first tandem CD20-CD19, non-cryopreserved CAR-T therapy — shows meaningful clinical benefit.

The study involved an older, clinically high-risk population with a median age of 74 years and showed zamto-cel was generally well tolerated.

According to the data, patients were randomised to zamto-cel or R-GemOx/Pola-BR. The study design allowed crossover, and 29 patients later received zamto-cel after failing to respond to the comparator regimens.

The blinded independent review committee found that median event-free survival was 6.2 months for zamto-cel, compared with 2.5 months for R-GemOx. Median progression-free survival was 8.5 months versus 3.3 months, respectively.

In the intent-to-treat population, the overall response rate (ORR) was 72 per cent with a 54 per cent complete response rate (CRR) for zamto-cel compared to 45 per cent ORR and 14 per cent CRR for R-GemOx.

The DALY 2-EU trial spans 12 European Union (EU) countries. Further analyses with extended follow-up are planned and will be presented at future meetings.

-- BERNAMA