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
PLEASE NOTE that, due to differences between patient populations etc., direct comparisons cannot be made between clinical trial & real-world outcomes.
A manageable safety profile confirmed in real-world clinical practice vs the JULIET trial1–4
Cytokine release syndrome*
JULIET trial†1,2
22.6%
Grade 3/4
Median time to onset
3 days
Median duration
7 days
RWE
CIBMTR Registry3
4.5%
Grade 3/4
Median time to onset
4 days
Median duration
5 days
RWE
CAR T-Cell Consortium4
1%
Grade 3/4
Median time to onset
3 days
Median duration
3 days
Neurological events
JULIET trial†1,2
11.3%
Grade 3/4
Median time to onset‡
6 days
Median duration§
13 days
RWE
CIBMTR Registry3
5%
Grade 3/4
Median time to onset
8 days
Median duration
6.5 days
RWE
CAR T-Cell Consortium4
0%
Grade 3/4
Median time to onset
4 days
Median duration
4 days
In the US CAR T-Cell Consortium, 63% of patients were infused in the outpatient setting.4
Sustained & clinically-meaningful improvements for responding patients across all domains¶ at 3, 6, 12, & 18 months (patient-reported outcome measures, N=99)5
Kymriah causes responses that correspond with long-term improvement in patient quality of life5
*CRS in JULIET was graded using the Penn Scale. CRS in real-world registries was graded using the ASTCT scale.
†Data taken from 32.6-month analysis.1,2
‡The median time to onset refers to first grade 3/4 serious neurological events only.2
§The median time to resolution is among all the episodes of serious neurological adverse reactions.2
¶As measured by FACT-G, a 27-item questionnaire designed to measure four domains of health-related quality of life (HRQOL) in cancer patients. Responding patients defined as those with CR or PR.5
ASTCT, American Society for Transplantation and Cellular Therapy; CAR-T, chimeric antigen receptors cell therapy; CIBMTR, Center for International Blood & Marrow Transplant Research; CRS, cytokine release syndrome; DLBCL, diffuse large B-cell lymphoma; RWE, real-world evidence.
References
- Kymriah Summary of Product Characteristics; Novartis Pharmaceuticals UK Ltd.
- Data on file. CTL019C2201. 30 month follow-up report. Novartis Pharmaceuticals Corp; December 11, 2019.
- 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.
- Maziarz RT, et al. Blood Adv. 2020;4:629–637.
