Kymriah® is indicated for the treatment of paediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse, and adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.1
- Open-label, multicentre, single-arm, global study1
- Primary endpoint: Overall response rate (ORR) [complete response (CR) + partial response (PR)]1 per independent review committee1
- Adult patients with relapsed or refractory disease after ≥2 lines of chemotherapy, including rituximab and anthracycline, and either having failed autologous HSCT, or being ineligible for or not consenting to autologous HSCT1,2
- 167 patients enrolled; 115 patients were infused with tisagenlecleucel and evaluable for efficacy and safety with a median follow-up of 40.3 months3
- Secondary endpoints: Included duration of response, overall survival, and safety1
JULIET study schematic3
*To be completed 2 to 14 days prior to Kymriah® infusion.
†Infusion conducted on an inpatient or outpatient basis at investigator discretion.
Interact below to find out about the Phase 2 registration study establishing initial safety and efficacy in heavily pre-treated adult patients with R/R DLBCL1–3
Deep and durable responses
autoSCT, autologous stem cell transplant; CR, complete response; cy, cyclophosphamide; DLBCL, diffuse large B-cell lymphoma; DOR, duration of response; Flu, fludarabine; HSCT, haematopoietic stem-cell transplantation; LD, low-dose; LDC, low-dose chemotherapy; mo, month; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; R/R, relapsed and/or refractory.
References
- Kymriah (tisagenlecleucel) Summary of Product Characteristics; Novartis Pharmaceuticals UK Ltd.
- Schuster S, et al. N Engl J Med. 2019;380(1):45–56.
- Schuster S, et al. Abstract 626 presented at 60th ASH Annual Meeting, 2018, 1–4 December; San Diego, USA.
- Jaeger U, et al. Poster presented at the 2020 ASH Annual Meeting & Exposition, held virtually on 5–8 December 2020. Poster 1194.
- Pasquini MC, et al. Blood Adv. 2020;4(21):5414–5424.
- Riedell P, et al. Transplantation & Cellular Therapy Annual Meeting; February 19-23, 2020; Orlando, FL. Presentation 52.
- Jaeger U, et al. Poster presented at the 2021 Transplantation and Cellular Therapy Annual Meeting, held virtually on 8–12 February 2021. Poster 212.
- Andreadis C, et al. Poster presented at the 61st American Society of Hematology Annual Meeting; December 7–10, 2019; Orlando, FL. Poster 2883.
