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Strong long-term efficacy results in a challenging TO TREAT patient population:

MORE THAN 8 OUT OF EVERY 10 PATIENTS ACHIEVED REMISSION IN THE ELIANA CLINICAL TRIAL1

KYMRIAH delivers powerful responses where prior therapies have failed
  • Minimal residual disease negative (MRD–) status provides a strong marker for positive prognosis2
  • In a supportive study, KYMRIAH persisted in the blood and bone marrow for over 2 years1

Remission maintained over time by the majority of responders1

All patients who responded at 12 months were still in response at 18 months
  • Median duration of remission (DOR) not yet reached among the 65 responders (95% CI, 20.0, NE)

Estimated number of Responders to still be in remission
66 of responders estimated
to still be responding
AT12 months
66 of responders estimated
to still be responding
at18 months

DOR was defined as time since onset of CR or CRi to relapse or death due to underlying indication, whichever is earlier (N=65).

ONGOING CLINICAL BENEFIT WITH STRONG LONG-TERM SURVIVAL RESULTS1


Overall Survival
76 probability of survival
AT12 months
66 probability of survival
at24 months
OS was defined as time from date of KYMRIAH infusion to the date of death due to any cause (N=79).

KYMRIAH continues to be a potentially definitive therapy for patients in the ELIANA clinical trial3

90 of patients who achieved remission have
not yet required subsequent therapy (71/79)

  • All patients who moved on to subsequent therapy received a stem cell transplant (8/79)1

TRANSFORMING PATIENTS' QUALITY OF LIFE (QOL)1,4,5

KYMRIAH led to a decrease in severity of problems related to mobility, self-care, usual activities,
pain/discomfort, and anxiety/depression as early as Month 3
aPatient-reported outcome results are mean values from a study population of patients ±8 years of age (n=51/61). Population at each time point is the number of patients with non-missing score at that time point.1

Baseline characteristics in eliana study1

patient age, years:
3 - 24
disease status:
92
relapsed disease
8
primary refractory
prior allogeneic sct:
61
CR, complete remission; CRi, complete remission with incomplete blood count recovery; ORR, overall response rate; OS, overall survival; SCT, stem cell transplant.
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References:
  1. Kymriah Summary of Product Characteristics. Novartis Pharma AG; 2022.
  2. Borowitz MJ, Wood BL, Devidas M, et al. Prognostic significance of minimal residual disease in high risk B-ALL: a report from Children’s Oncology Group study AALL0232. Blood. 2015;126(8):964-971.
  3. Grupp S, Hu ZH, Zhang Y, et al. Tisagenlecleucel chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory children and young adults with acute lymphoblastic leukemia (ALL): real world experience from the Center for International Blood & Marrow Transplant Research (CIBMTR) cellular therapy (CT) registry. Presented at: 61st American Society of Hematology Annual Meeting; December 7-10, 2019; Orlando, FL. Abstract 2619.
  4. Varni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003;3(6):329-341.
  5. Pickard AS, Neary MP, Cella D. Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health Qual Life Outcomes. 2007;5:70. doi:10.1186/1477-7525-5-70.

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