TECARTUS® is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton´s tyrosine kinase (BTK) inhibitor.¹
The first licensed CAR T therapy for r/r MCL¹
The second CAR T product in the Kite CAR T portfolio, TECARTUS®, was approved for the treatment of r/r mantle cell lymphoma in December 2020.
The efficacy and safety of TECARTUS® in r/r MCL
The efficacy and safety of Tecartus in adult patients with relapsed or refractory MCL who had previously received anthracycline or bendamustine-containing chemotherapy, an anti CD20 antibody, and a Bruton’s tyrosine kinase inhibitor (BTKi) (ibrutinib or acalabrutinib), was evaluated in a phase 2 single-arm, open-label, multi-centre trial (ZUMA-2). In the study, 68 patients were treated with Tecartus. The primary endpoint was objective response rate (ORR); secondary endpoints included duration of response (DOR), overall survival (OS), progression free survival (PFS) and severity of adverse events.¹ ²
The primary efficacy analysis showed that 93% (95% confidence interval [CI], 84 to 98) of the 60 patients in the primary efficacy analysis had an objective response; 67% (95% CI, 53, 78) had a complete response.¹ ²
The updated 24-month follow-up analyses of efficacy were conducted using the modified intent to treat (mITT) analysis set, which consisted of 68 patients treated with Tecartus. In the 24-month follow up analysis, the ORR and CR rates in the 68 patients in the mITT analysis set were 91% and 68% respectively.¹
ORR, CR and PR from the 24-months follow-up (mITT, N=68), where the median follow-up among all 68 treated patients was 35.6 months. Figure adapted from the SmPC.¹
Three-year follow-up outcomes: Duration of Response (DOR) and Overall Survival (OS)
After a median follow-up of 35.6 months, median OS of 46.6 months was achieved with Tecartus® in high-risk and heavily pretreated patient population of ZUMA-2 trial. Median DOR was 28.2 months (95% CI, 13,5 to 47,1).³
Safety profile of TECARTUS®
The safety data described in this section reflect exposure to Tecartus in ZUMA-2, a Phase 2 study with a total of 82 patients with relapsed/refractory MCL.
The most significant and frequently occurring adverse reactions were CRS (91%), infections (55%) and encephalopathy (51%).
Serious adverse reactions occurred in 56% of patients. The most common serious adverse reactions included encephalopathy (26%), infections (28%) and cytokine release syndrome (15%).¹
Please see the summary of product characteristics for full information on the safety profile of Tecartus®.
References
- Tecartus Summary of Product Characteristics
- Wang M, et al. KTE-X19 CAR-T Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med 2020;382(14):1331–1342.
- Wang M, et al. Three-year follow-up of outcomes with KTE-X19 in patients with relapsed/refractory mantle cell lymphoma in ZUMA-2. J Clin Oncol. 2022;40(16_suppl):7518.
SE-TEC-0030 | 09/2024
Related information
Tecartus in aALL
Tecartus is also approved for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
Treatment journey
Find for each step in the treatment journey, a section focusing on the patients concerns and questions.
