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Delivers high rates of durable responses where prior therapies have failed1

Response attained and sustained in difficult-to-treat patients
  • 54% of patients [53/99] achieved a response with KYMRIAH in the JULIET clinical trial: the primary endpoint of best overall response was met
Data showing high rates of lasting responses where other therapies have failed
  • Response at 3 months was 34% CR, 5% PR, and 39% ORR
  • Response at 6 months was 31% CR, 3% PR, and 34% ORR
View Trial Design

Strong long-term efficacy even in a heavily pretreated patient population1

  • All patients who responded at 12 months were still in response at 18 months
  • Median duration of response not yet reached among the 99 responders (95% CI, 10.0, NE)
Duration of response
63 of responders estimated
to still be responding
AT12 months
63 of responders estimated
to still be responding
AT18 months
Duration of response was defined as time from achievement of CR or PR, whichever occurs first, to relapse or death due to DLBCL.

Ongoing CLINICAL BENEFIT with strong LONG-TERM SURVIVAL RESULTS1

Median overall survival with KYMRIAH: 10.3 months (95% CI, 6.6, 21.1)
Overall Survival
48 probability of survival
AT12 months
39 probability of survival
at24 months

The phase 2 JULIET trial: Establishing safety and efficacy in heavily pretreated adult patients with R/R DLBCL1-4

  • Open-label, multicentre, single-arm, and global: 27 sites in 11 countries across Europe, North America, Australia, and Asia1-4
  • Primary endpoint: ORR (CR + PR)
    • Assessed in 115 patients who received KYMRIAH manufactured at the Novartis facility in the United States, and who
      completed ≥3 months of follow-up or had discontinued earlier1,2
  • Secondary endpoint: Duration of response1
  • 90% of patients received bridging therapy for disease stabilisation (103/115)

aTo be completed 2 to 14 days prior to KYMRIAH infusion.1,3
bInfusion conducted on an inpatient or outpatient basis at investigator discretion.1,3
The recommended lymphodepleting chemotherapy regimen is fludarabine (25 mg/m2 intravenous daily for 3 days) and cyclophosphamide
(250 mg/m2 intravenous daily for 3 days starting with the first dose of fludarabine).1
CR, complete response; ORR, overall response rate; PR, partial response.
NEXT: DLBCL Safety
References:
  1. Kymriah Summary of Product Characteristics. Novartis Pharma AG; 2022.
  2. Schuster SJ, Bishop MR, Tam CS, et al. Primary analysis of JULIET: a global, pivotal, phase 2 trial of CTL019 in adult patients with relapsed or refractory diffuse large B-cell lymphoma. Poster presented at: 59th American Society of Hematology Annual Meeting and Exposition; December 9-12, 2017; Atlanta, GA. Abstract 577.
  3. Schuster SJ, Bishop MR, Tam CS, et al. Global trial of the efficacy and safety of CTL019 in adult patients with relapsed or refractory diffuse large B-cell lymphoma: an interim analysis of the JULIET study. Poster presented at: 22nd Congress of the European Hematology Association; June 22-25, 2017; Madrid, Spain.
  4. Grupp SA, Maude SL, Rives S, et al. Updated analysis of the efficacy and safety of tisagenlecleucel in pediatric and young adult patients with relapsed/refractory acute lymphoblastic leukemia. Presented at: 60th American Society of Hematology Annual Meeting; December 1-4, 2018; San Diego, CA. Abstract 895.

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