Response Rate N = 68  

Overall Response Rate (ORR) (CR+PR), n (%)

(95% CI) 

Complete Response Rate n (%)

 (95% CI)

 Partial Response Rate n (%)

 (95% CI) 34 (50 %)

(37.6%, 62.4%) 

22 (32%) 

(21.5%, 44.8%)

12 (18%)

(9.5%, 28.8%) 

Table 10. Duration of Responsea (Months) in Relapsed or Refractory DLBCL in the JULIET Study 

CR, Complete Response; DOR, Duration of Response: NE, not estimable, PR, partial response

aAmong all responders. DOR measured from date of first objective response to date of progression or death from relapse.

bKaplan-Meier estimate in months

cA + sign indicates a censored value  

Duration of Response Results 

Overall DOR for responders (months) N = 34 

Median DORa,b NE  

(95% CI)  (5.1, NE)  

Rangec (0.03+ – 11.3+)  

Median Follow-up (95% CI)b 9.4 (7.9, 10.8)  

DOR if BOR is CR N = 22 

Median DORa,b NE  

(95% CI)  (10.0, NE)  

Rangec (1.5+ – 11.3+)  

DOR if BOR is PR N = 12 

Median DORa,b 3.4  

(95% CI)  (1.0, NE)  

Rangec (0.03+ – 11.3+)  

15     REFERENCES 

1. Porter, D. et al (2015). Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia (Table S4A). Sci. Transl. Med., 303ra139. DOI: 10.1126/scitranslmed.aac5415

16     HOW SUPPLIED/STORAGE AND HANDLING 

KYMRIAH is supplied as a frozen suspension of genetically modified autologous T cells in an infusion bag(s) labeled for the specific recipient. KYMRIAH is shipped directly to the cell lab associated with the infusion center in a liquid nitrogen Dewar. Product and patient-specific labels are located inside the Dewar.

Ped ALL: NDC 0078-0846-19

DLBCL: NDC 0078-0958-19

Confirm patient identity upon receipt.

Store infusion bag(s) in the vapor phase of liquid nitrogen (less than or equal to minus 120°C) in a temperature-monitored system.

Use closed, break-proof, leak-proof containers when transporting infusion bags within the facility.

Thaw KYMRIAH prior to infusion [see Dosage and Administration (2)].

17  PATIENT COUNSELING INFORMATION 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Ensure that patients understand the risk of manufacturing failure. This has been reported in up to 9% of manufacturing attempts. In case of a manufacturing failure, a second manufacturing of KYMRIAH may be attempted. In addition, while the patient awaits the product, additional chemotherapy (not the lymphodepletion) may be necessary and may increase the risk of adverse events during the pre-infusion period.

Prior to infusion, advise patients of the following risks: