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Choose YESCARTA for your best chance at a CURE* vs standard therapy in adults with 2L R/R LBCL1-4

*Cure in LBCL can be defined as when the therapy has been stopped and (1) the survival curve plateaus; (2) 3-year OS data; and/or at least 2-year EFS data.3-6

  • Head-to-head study: YESCARTA vs standard therapy (salvage chemotherapy +/-HDT+ASCT) in 359 adult patients with R/R LBCL. Patients were randomized 1:1 to YESCARTA (N=180) and standard therapy (N=179) and stratified by 1L response and 2L age-adjusted IPI; 2 recipients of nonconformal product are included in the efficacy analysis1,7
  • EFS (primary endpoint): HR: 0.40 (95% CI, 0.31-0.51); P<0.0001; median follow-up time in the primary analysis: 22.1 months1,7
  • Other secondary endpoints included OS, ORR, DOR, PFS, PROs, and safety7-9
  • OS (select secondary endpoint): HR: 0.73 (95% CI, 0.54-0.98; P=0.0168)1

YESCARTA is a one-time treatment that demonstrated statistically significant improvement in EFS vs standard therapy1,7

18 month event-free survival rate chart showing 41% vs.16% at 24 months EFS

More than double the number of patients treated with YESCARTA remain event free at 2 years compared with standard therapy1,7

  • EFS is defined as the time from randomization to the earliest date of disease progression or relapse, best response of stable disease up to and including the day 150 assessment, commencement of new lymphoma therapy, or death from any cause. Response was assessed by an independent review committee, per the International Working Group Lugano classification (Cheson 2014)1
  • EFS rate at 2 years is a KM estimate and should be carefully interpreted due to the number of censored patients.7 Data are not included in the YESCARTA Prescribing Information

EFS improvements were consistent across a broad patient population, including elderly, high-risk, and poor performance status patients1,7,10

Preplanned Subgroup Analysis

The efficacy of YESCARTA was evaluated in a separate analysis of patients aged ≥65 years11†

Limitations: These results represent prespecified subgroup analyses of the ZUMA-7 study; however, these analyses were not study objectives and the study was therefore not powered or adjusted for multiplicity to assess efficacy in these subgroups.7

72% reduction in EFS events in patients infographic

A preplanned subgroup analysis of ZUMA-7 evaluated outcomes of YESCARTA (N=51) vs standard therapy (N=58) in patients aged ≥65 years11

  • Of these, 26 patients in the YESCARTA arm and 27 in the standard therapy arm were aged ≥70 years
  • Median EFS in patients aged ≥65 years was 21.5 months vs 2.5 months with standard therapy
    • The KM estimate of EFS at 24 months was 48% with YESCARTA vs 15% with standard therapy

In an additional subgroup of patients aged ≥70 years, 42% were event free at 12 months with YESCARTA vs 4% in the standard therapy arm, according to KM estimate11†

Median EFS in patients over 70 in ZUMA-7 showing 5.3 for YESCARTA vs. 1.7 for standard therapy

†EFS was analyzed according to investigator assessment for subgroup analyses and by blinded central review for the primary analysis.11

Median event-free survival was 5.3 months with YESCARTA vs 1.7 months with standard therapy in patients aged ≥70 years12

YESCARTA is the ONLY CAR T treatment to demonstrate SUPERIOR overall survival vs standard therapy in adult patients with 2L LBCL1,13

YESCARTA vs standard therapy survival graph with a 27% reduction in the risk of death

‡KM estimate.2

Of patients alive at ~4 years, 75% did not need additional cancer treatment1,15

  • OS was a secondary endpoint of the phase 3, randomized, open-label, multicenter ZUMA-7 study.1,7 Not all data continued to be captured at the long-term follow-up. Types of data captured include investigator-assessed OS, PFS, and adverse events13
  • Median OS was not estimable with YESCARTA at an estimated median follow-up of 46.7 months overall1§
  • 57% of patients received cellular immunotherapy after no response to or relapse after randomization to standard therapy arm1
    • Of the patients who received rescue cell therapy in the standard therapy arm, 78% received YESCARTA13

§The KM median OS was NE with YESCARTA (95% CI, 28.6-NE) vs 31.1 months with standard therapy (95% CI, 17.1-NE) (HR: 0.73 [95% CI, 0.54-0.98]; P=0.0168).1

Subgroup Analysis

Interim overall survival outcomes with YESCARTA® vs standard therapy in patients aged ≥70 years11,12

  • A preplanned subgroup analysis of ZUMA-7 evaluated outcomes of YESCARTA (N=51) vs standard therapy (N=58) in patients aged ≥65 years11
    • Of these, 26 patients in the YESCARTA arm and 27 in the standard therapy arm were aged ≥70 years
  • The 2-year KM estimate of OS in patients aged ≥65 years was 64% with YESCARTA vs 51% with standard therapy11
  • Median OS was 28.6 months with YESCARTA and NR with standard therapy11

Limitations: These results represent a separate, preplanned, post hoc subgroup analysis of patients aged ≥65 years in the ZUMA-7 study; however, this analysis was not a study objective; the data are descriptive and the study was not powered or adjusted for multiplicity to assess efficacy in this subgroup.7,11 These data are not included in the Prescribing Information for YESCARTA and should be carefully interpreted.

OS for patients over 70 in ZUMA-7 showing median of 22.9 for YESCARTA and 11.2 for standard therapy

Median overall survival was 23.9 months with YESCARTA and 11.2 months with standard therapy in patients aged ≥70 years12

YESCARTA demonstrated deep and durable remissions, with impressive objective response rate and complete remission rates1

ORR showing an 83% ORR with YESCARTA vs. 50% with standard therapy and CR rate showing a 65% remission rate with YESCARTA vs. 32% with standard therapy
  • The median DOR was 26.9 months (95% CI, 13.6-NE) in patients treated with YESCARTA (number of responders = 150)16
  • The estimated median DOR was 28.4 months (95% CI, 26.9-NE) in patients who achieved CR and 1.6 months (95% CI, 1.4-1.9) in patients who achieved a best response of PR1

Assessed per Cochran-Mantel-Haenszel method for best objective response rate. For all stratified analyses, stratification was based on response to 1L therapy (primary refractory vs relapse within 6 months of 1L therapy vs relapse within >6 but ≤12 months) and 2L age-adjusted IPI.1

Health-related quality of life (HRQoL) improvement with YESCARTA® vs standard therapy was confirmed in patients aged ≥65 years

  • HRQoL was one of the secondary endpoints of ZUMA-7. Data presented here are descriptive and are not included in the Prescribing Information. An improvement in mean EORTC QLQ-C30 Health Status/HRQoL scores from baseline to day 100 was reported with YESCARTA (n=165) vs standard therapy (n=131) (estimated difference: 18.1 [95% CI, 12.3-23.9])9
  • A preplanned subgroup analysis of ZUMA-7 patients aged ≥65 years evaluated YESCARTA across PRO measures, including EORTC QLQ-C30 Global Health Status/HRQoL* (N=88)11
    • 46 subjects in the YESCARTA arm and 42 subjects in the standard therapy arm had baseline PROs and ≥1 follow-up measure and were included for analysis in the HRQoL analysis set11
QoL questionnaire graph showing a comparison of HRQoL for YESCARTA vs. standard therapy

‡Mixed model includes variables for treatment, time, and treatment by time interaction (primary analysis) and is controlled for response to 1L therapy and age-adjusted IPI at screening.11

  • An improvement for patients aged ≥65 years in mean EORTC QLQ-C30 Global Health Status/HRQoL scores from baseline to day 150 was reported with YESCARTA vs standard therapy (estimated difference: 27.5 [95% CI, 16.2-38.8])11,12
    • The MID was defined as a change of ≥10-point improvement from screening for each EORTC QLQ-C30 score11
  • Per sensitivity analyses that were controlled for patterns of missingness and covariates, by day 150, mean estimated scores with YESCARTA returned to or exceeded scores at baseline vs 15 months later for standard therapy, where they still never equaled or exceeded baseline scores11
    • Score comparisons at later time points warrant cautious interpretation because attrition due to disease progression, new lymphoma therapy, or death was disproportionately higher in the standard therapy arm and may select for patients with the best outcomes11

European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire-C309

  • EORTC QLQ-C30 is a 30-item questionnaire that provides a multidimensional assessment of HRQoL, with a recall period of 1 week, through several scales:
    • 5 multi-item functional scales (physical, role, emotional, cognitive, and social functioning)9
    • 3 symptom scales (fatigue, nausea/vomiting, and pain)9
    • 6 single-item symptom scales (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties)9
    • 2 global scales (Global Health Status and HRQoL)9
  • No item occurs in more than one scale9
  • All of the scales and single-item measures range in score from 0 to 100. Higher scores for the functioning scales and Global Health Status denote a better level of functioning (ie, a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the patient)9
  • Each PRO score was to be examined via a series of MMRM that examined both the individual change in HRQoL scores over time and systematic differences between groups. The base MMRM was to fit to each PRO score with terms for treatment arm, time point (treated as discrete), and treatment by time interaction9
  • Via the MMRM, planned comparisons were to be conducted between treatment arms at predetermined specific time points of interest (study days 100 and 150 and months 9, 12, 15, 18, 21, and 24, or time of EFS event)9
    • MMRM is often used in randomized long-term trials that include repeated outcome measurements for each patient17
    • MMRM analysis takes into account the correlation seen within single patients so as to prevent biased results18

ZUMA-7 evaluated difficult-to-treat adult patients with high-risk characteristics in 2L LBCL1,7,10,11

Patient population chart who can be considered for treatment are: elderly, rapidly progressing, and high-risk

‡According to central laboratory.7

ZUMA-7: the LARGEST phase 3 CAR T 2L LBCL trial with the LONGEST follow-up (N=359)1§

  • A phase 3, randomized, open-label, multicenter study of YESCARTA single-infusion therapy vs standard therapy** (salvage chemotherapy +/- HDT+ASCT) in 359 adult patients with R/R LBCL. Patients were randomized 1:1 to YESCARTA (N=180) and standard therapy (N=179) and stratified by response to 1L therapy and 2L age-adjusted IPI. Two recipients of nonconformal product are included in the YESCARTA arm for the efficacy analysis1,7

§As of August 2024.

‖Refractory disease was defined as no complete response (CR) to 1L therapy; relapsed disease was defined as CR followed by biopsy-proven disease relapse1 12 months from completion of 1L therapy.7,8

YESCARTA patients underwent leukapheresis followed by conditioning chemotherapy with cyclophosphamide (500 mg/m2/day) and fludarabine (30 mg/m2/day) 5, 4, and 3 days before receiving a single YESCARTA infusion (target intravenous dose, 2x106 CAR T cells/kg). Optional bridging therapy was limited to glucocorticoids only.7

#57% of patients received cellular immunotherapy after no response or relapse after randomization to standard therapy arm.1

**Standard-care chemotherapy could include 2 to 3 cycles of R-ICE, R-GDP, R-ESHAP, R-DHAP, or R-DHAX followed by high-dose chemotherapy and autologous stem cell transplant in patients with disease response.7

In ZUMA-7, nearly all patients in the YESCARTA arm successfully completed treatment7

CR statistics showing 94% completion rate with YESCARTA vs. 35% with standard therapy
  • 33% of patients treated with YESCARTA received bridging corticosteroid therapy1††

Baseline characteristics in ZUMA-7 may resemble the patients you see in practice7

Broad range of patient baseline characteristics: age, gender, ECOG PS, 2L age-adjusted IPI, and disease type

††Bridging therapy was restricted to glucocorticoids to avoid the progression of lymphoma during the YESCARTA manufacturing process and to isolate the effects of CAR T-cell therapy as 2L therapy.7

‡‡According to the investigator.7

§§Other disease types at baseline include Epstein-Barr virus–positive DLBCL, primary cutaneous DLBCL (leg type), and other.7

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YESCARTA demonstrated a well-characterized safety profile3

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Refer eligible patients to a YESCARTA Authorized Treatment Center

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1L=first-line; 2L=second line; ALT=alanine aminotransferase; ASCT=autologous stem cell transplant; AST=aspartate aminotransferase; CAR T=chimeric antigen receptor T cell; CI=confidence interval; CR=complete response; CrCl=creatinine clearance; DLBCL=diffuse large B-cell lymphoma; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; EFS=event-free survival; EORTC QLQ-C30=European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire; HDT=high-dose therapy; HGBCL=high-grade B-cell lymphoma; HR=hazard ratio; HRQoL=health-related quality of life; IPI=International Prognostic Index; KM=Kaplan-Meier; LBCL=large B-cell lymphoma; LVEF=left ventricular ejection fraction; MID=minimally important difference; MMRM=mixed-effect models for repeated measures; NE=not estimable; NOS=not otherwise specified; NR=not reached; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PR=partial response; PRO=patient-reported outcome; R-DHAP=rituximab, dexamethasone, high-dose cytarabine, cisplatin; R-DHAX=rituximab, dexamethasone, high-dose cytarabine, oxaliplatin; R-ESHAP=rituximab, etoposide, methylprednisolone, high-dose cytarabine, cisplatin; R-GDP=rituximab, gemcitabine, dexamethasone, cisplatin; R-ICE=rituximab, ifosfamide, carboplatin, etoposide; R/R=relapsed/refractory; TFL=transformed follicular lymphoma.

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES

  • 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.
  • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA.
  • YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS.

CYTOKINE RELEASE SYNDROME (CRS)
CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days).

CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS following infusion 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
Neurologic toxicities including immune effector cell-associated neurotoxicity syndrome (ICANS) that were fatal or life-threatening occurred following treatment with YESCARTA. Neurologic toxicities occurred in 78% (330/422) of patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%.

Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range: 1-133 days) and median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion in 87% of affected patients with LBCL and 74% of affected patients with iNHL.

The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities; 8% (3/39) developed Grade 3 and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset, and decrease the duration of CRS.

Monitor patients for signs and symptoms of neurologic toxicities following infusion at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS
Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS. The required components of the YESCARTA and TECARTUS REMS are:

  • Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS.

Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS
Allergic reactions may occur with the infusion of YESCARTA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in YESCARTA.

SERIOUS INFECTIONS
Severe or life-threatening infections occurred after YESCARTA infusion. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. 

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV and management in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS
Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 or higher cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA
B-cell aplasia and hypogammaglobulinemia can occur in patients receiving YESCARTA. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES
Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes.

Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS
The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting.

The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

INDICATIONSMORE

YESCARTA® is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

  • Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
  • 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.

Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

Authorized Treatment Centers are independent facilities certified to dispense Kite CAR T therapies. Choice of an Authorized Treatment Center is within the sole discretion of the physician and patient. Kite does not endorse any individual treatment sites.

References: 1. YESCARTA® (axicabtagene ciloleucel). Prescribing information. Kite Pharma, Inc; 2024. 2. Westin JR, Oluwole OO, Kersten MJ, et al. Survival with axicabtagene ciloleucel in large B-cell lymphoma. N Engl J Med. 2023;389(2):148-157 (suppl). doi:10.1056/NEJMoa2301665 3. Ravi P, Kumar SK, Cerhan JR, et al. Defining cure in multiple myeloma: a comparative study of outcomes of young individuals with myeloma and curable hematologic malignancies. Blood Cancer J. 2018;8(3):26. doi:10.1038/s41408-018-0065-8 4. Patel AR, Ray M, Rodriguez-Guadarrama YA, et al. Statistical challenges from trials of potentially curative treatments: validation of cure assumptions when analyzing ZUMA-7 follow-up data of axi-cel and standard of care therapy. Blood. 2023;142 (suppl 1):6899. doi:10.1182/blood-2023-181255 5. Howlader N, Mariotto AB, Besson C, et al. Cancer-specific mortality, cure fraction, and noncancer causes of death among diffuse large B-cell lymphoma patients in the immunochemotherapy era. Cancer. 2017;123(17):3326-3334. 6. Maurer MJ, Ghesquières H, Jais JP, et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32(10):1066-1073. 7. Locke FL, Miklos DB, Jacobson CA, et al. Axicabtagene ciloleucel as second-line therapy for large B-cell lymphoma. N Engl J Med. 2022;386(7):640-654. 8. Locke FL, Miklos DB, Jacobson CA, et al. Axicabtagene ciloleucel as second-line therapy for large B-cell lymphoma. N Engl J Med. 2022;386(7):640-654 (protocol). doi:10.1056/NEJMoa2116133 9. Elsawy M, Chavez JC, Avivi I, et al. Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma. Blood. 2022;140(21):2248-2260. 10. YESCARTA® (axicabtagene ciloleucel). Biologics license application. Kite Pharma, Inc; 2021. 11. Westin JR, Locke FL, Dickinson M, et al. Safety and efficacy of axicabtagene ciloleucel versus standard of care in patients 65 years of age or older with relapsed/refractory large B-cell lymphoma. Clin Cancer Res. 2023;29(10):1894-1905. 12. Westin JR, Locke FL, Dickinson M, et al. Safety and efficacy of axicabtagene ciloleucel versus standard of care in patients 65 years of age or older with relapsed/refractory large B-cell lymphoma. Clin Cancer Res. 2023;29(10):1894-1905 (suppl). doi:10.1158/1078-0432.CCR-22-3136 13. Westin JR, Oluwole OO, Kersten MJ, et al. Survival with axicabtagene ciloleucel in large B-cell lymphoma. N Engl J Med. 2023;389(2):148-157. 14. Locke FL, Miklos DB, Jacobson CA, et al. Axicabtagene ciloleucel as second-line therapy for large B-cell lymphoma. N Engl J Med. 2022;386(7):640-654 (protocol). doi:10.1056/NEJMoa2116133 15. Data on file. Kite Pharma, Inc; 2024. 16. Locke FL, Miklos DB, Jacobson CA, et al. Axicabtagene ciloleucel as second-line therapy for large B-cell lymphoma. N Engl J Med. 2022;386(7):640-654 (suppl). doi:10.1056/NEJMoa2116133 17. Bell ML, Rabe BA. The mixed model for repeated measures for cluster randomized trials: a simulation study investigating bias and type I error with missing continuous data. Trials. 2020;21(1):148. 18. Detry MA, Ma Y. Analyzing repeated measurements using mixed models. JAMA. 2016;315(4):407-408.