One-time therapy for adults with relapsed / refractory ( r / r ) large B-cell lymphoma ( LBCL ) after ≥2 lines of systemic therapy :
RELAPSE IS LIFE-CHANGING SO , YOU CHOSE YESCARTA ®
ONLY CAR T TO PRESENT SURVIVAL DATA WITH AT LEAST 3 YEARS OF FOLLOW-UP
~ HALF
OF PATIENTS ALIVE
BEFORE . AND AFTER .
AFTER 3 YEARS 3 *
Relapse 3 years ago
72 % ORR | 51 % CR 1 , 2 with an 11.6-month median follow-up
47 % alive and 25.8-month median OS with a 39.1-month median follow-up 3 *
* ZUMA-1 was a phase 2 , open-label , single-arm , multicenter pivotal trial in 101 adults with r / r LBCL . For FDA approval , efficacy was established on the basis of CR rate and DOR , as determined by an IRC . 1 , 4 OS was a secondary endpoint . 4 OS data are descriptive and should be carefully interpreted in light of the single-arm design . OS data are not included in the Prescribing Information for YESCARTA . Not all data continued to be captured at the 3-year follow-up ; only OS , investigator-assessed response , and adverse event reporting were captured . 5
WELL-CHARACTERIZED SAFETY
Most CRS and neurologic events occurred early , were generally reversible , and managed per established guidance 1 , 6 CRS : Grade ≥3 incidence , 13 %; overall incidence , 94 %; median time to onset , 2 days ( range : 1 to 12 days ); median duration , 7 days ( range : 2 to 58 days ) 1 Neurologic toxicities : Grade ≥3 incidence , 31 %; overall incidence , 87 %; median time to onset , 4 days ( range : 1 to 43 days ); median duration , 17 days 1
ONLY CAR T
3500 + PATIENTS
TREATED 7 †
†
Global commercial and clinical trial data in patients with r / r LBCL after ≥2 lines of systemic therapy as of August 2 , 2020 .
INDICATION YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy , including diffuse large B-cell lymphoma ( DLBCL ) not otherwise specified , primary mediastinal large B-cell lymphoma , high grade B-cell lymphoma , and DLBCL arising from follicular lymphoma .
Limitation of Use : YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma .
IMPORTANT SAFETY INFORMATION BOXED WARNING : CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES ∙ Cytokine Release Syndrome ( CRS ), including fatal or life-threatening reactions , occurred in patients receiving YESCARTA . Do not administer YESCARTA to patients with active infection or inflammatory disorders . Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids .
∙ Neurologic toxicities , including fatal or life-threatening reactions , occurred in patients receiving YESCARTA , including concurrently with CRS or after CRS resolution . Monitor for neurologic toxicities after treatment with YESCARTA . Provide supportive care and / or corticosteroids as needed .
∙ YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy ( REMS ) called the YESCARTA and TECARTUS REMS Program .
Please see Important Safety Information continued on adjacent page .
CYTOKINE RELEASE SYNDROME ( CRS ) occurred in 94 % of patients , with 13 % ≥ Grade 3 . Among patients who died after receiving YESCARTA , 4 had ongoing CRS at death . The median time to onset was 2 days ( range : 1-12 days ) and median duration was 7 days ( range : 2-58 days ). Key manifestations include fever ( 78 %), hypotension ( 41 %), tachycardia ( 28 %), hypoxia ( 22 %), and chills ( 20 %). Serious events that may be associated with CRS include cardiac arrhythmias ( including atrial fibrillation and ventricular tachycardia ), cardiac arrest , cardiac failure , renal insufficiency , capillary leak syndrome , hypotension , hypoxia , and hemophagocytic lymphohistiocytosis / macrophage activation syndrome . Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion . Following infusion , monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility , and for 4 weeks thereafter . Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time . At the first sign of CRS , institute treatment with supportive care , tocilizumab or tocilizumab and corticosteroids as indicated .
NEUROLOGIC TOXICITIES occurred in 87 % of patients , 98 % of which occurred within the first 8 weeks with a median time to onset of 4 days ( range : 1-43 days ) and a median duration of 17 days . Grade ≥3 occurred in 31 % of patients . The most common neurologic toxicities included encephalopathy ( 57 %), headache ( 44 %), tremor ( 31 %), dizziness ( 21 %), aphasia ( 18 %), delirium ( 17 %), insomnia ( 9 %), and anxiety ( 9 %). Prolonged encephalopathy lasting up to 173 days was noted . Serious events including leukoencephalopathy and seizures , as well as fatal and serious cases of cerebral edema have occurred . Following YESCARTA infusion , monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility , and for 4 weeks thereafter , and treat promptly .