Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).¹
The first CAR T therapy approved for r/r adult ALL (26+ years) ¹
Tecartus was EMA approved for the treatment of r/r adult ALL in September 2022. Since August 2024, Tecartus is recommended by the NT-council also in r/r aALL2.
The efficacy and safety of TECARTUS® in r/r aALL
A Phase 2, open-label, multicenter trial evaluated the efficacy and safety of Tecartus in adult patients with relapsed or refractory B-precursor ALL. Relapsed or refractory was defined as one of the following: primary refractory; first relapse following a remission lasting ≤ 12 months; relapsed or refractory after second-line or higher therapy; relapsed or refractory after allogeneic stem cell transplant (allo-SCT). 55 patients were treated with Tecartus.¹
The primary endpoint was overall complete remission rate (OCR) (complete remission [CR] + complete remission with incomplete hematologic recovery [CRi]) in patients treated with Tecartus. In the mITT population, the OCR rate was 70.9% with a CR rate of 56.4% (Table 7), which was significantly greater than the prespecified control rate of 40%. Among the 39 patients who achieved a CR or CRi, the median time to response was 1.1 months (range: 0.85 to 2.99 months).¹
Durable outcomes
Summary of the efficacy results for the two-year follow-up of ZUMA-3
In the two-year follow-up analysis, the median duration of response was 14.6 months (95% CI: 9.4, NE); median overall survival was 25.4 months in all treated patients (95% CI: 16.2, NE) (median follow-up of 26.8 months).

Safety profile of Tecartus in aALL®
The safety data described in this section reflect exposure to Tecartus in ZUMA-3, a Phase 1/2 study with total of 100 patients with r/r B-cell precursor ALL
The most significant and frequently occurring adverse reactions were CRS (91%), encephalopathy (57%), and infections (41%).
Serious adverse reactions occurred in 70% of patients. The most common serious adverse reactions included CRS (25%), infections (22%) and encephalopathy (21%). ¹
Please see the summary of product characteristics for full information on the safety profile of Tecartus®.
References
- Tecartus Summary of Product Characteristics
- https://samverkanlakemedel.se/produktinfo/tecartus-brexukabtagen-autoleucel. Latest access Sep 20 2024.
SE-TEC-0029 | 09/2024
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