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

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

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)

References:
  1. Kymriah Summary of Product Characteristics. Novartis Pharma AG; 2021.
  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.