Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

Overall response rate is the percent of participants with a best overall response (BOR) of either complete response (CR) or partial reasons (PR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment. CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment. PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size. PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake \> mediastinum but ≤ liver; 4- uptake moderately \> liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Time frame: From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months)

Population: All participants with PET positive disease who received at least one infusion of JCAR017

Change from baseline in Chemistry laboratory analysis. Includes Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase. Baseline is the last observation collected prior to or on the date of product infusion.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests

Change from baseline in Chemistry laboratory analysis. Includes Albumin. Baseline is the last observation collected prior to or on the date of product infusion.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests

Change from baseline in Chemistry laboratory analysis. Includes Bilirubin, Creatinine, Direct Bilirubin, and Urate. Baseline is the last observation collected prior to or on the date of product infusion.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests

Change from baseline in Chemistry laboratory analysis. Includes Calcium Corrected, Magnesium, Phosphate, Potassium, and Sodium. Baseline is the last observation collected prior to or on the date of product infusion.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests

Change from baseline in Hematology laboratory analysis. Includes Hemoglobin. Baseline is the last observation collected prior to or on the date of product infusion.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for hematology laboratory tests

Change from baseline in Hematology laboratory analysis. Includes Leukocytes, Lymphocytes, Neutrophils, and Platelets. Baseline is the last observation collected prior to or on the date of product infusion.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for hematology laboratory tests

Complete response rate (CRR) was defined as the percent of participants with a best overall response (BOR) of complete response (CR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment. CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment. PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake \> mediastinum but ≤ liver; 4- uptake moderately \> liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Time frame: From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplant (up to approximately 24 months)

Population: All participants with PET positive disease who received at least one infusion of JCAR017

Duration of response (DOR) is defined as the time from first complete response(CR) or partial response (PR) to progressive disease (PD) or death, whichever occurred first. CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment. PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size. PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake \> mediastinum but ≤ liver; 4-uptake moderately \> liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Time frame: From first dose to up to approximately 24 months

Population: All participants with PET positive disease who received at least one infusion of JCAR017 and achieved a response (CR or PR)

DOR for participants with a best overall response of CR was defined as the time from documentation of first response (or CR) to progressive disease (PD) or death, whichever occurred first. The first documentation of CR/PR is the latest of all dates of required measurements to establish the response. The progression date is the earliest date of all assessments that led to a response assessment of PD. CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment. PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake \> mediastinum but ≤ liver; 4-uptake moderately \> liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Time frame: From first dose to up to approximately 24 months

Population: All participants with PET positive disease who received at least one infusion of JCAR017 and achieved complete response (CR)

EFS is defined as the time from JCAR017 infusion to the earliest of the following events: death from any cause, progressive disease (PD), or starting a new anticancer therapy. Kaplan-Meier (KM) methodology will be used to analyze EFS. PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake \> mediastinum but ≤ liver; 4-uptake moderately \> liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Time frame: From first dose to death from any cause, progressive disease (PD), or starting a new anticancer therapy (up to approximately 24 months)

Population: All participants with PET positive disease who received at least one infusion of JCAR017

The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-5L health states ranged from -.594 for the worst (55555) to 1 for the best (11111) for UK value set with an optimal health state is assigned a score of 1.00, death is assigned a score of 0.00 and negative values representing values as worse than dead. A change of .08 is considered to be a clinically meaningful change in health utility.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who completed 5-dimension measures at baseline and at least one post-baseline

The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. The LYM items are scored on a 0 (Not at all) to 4 (Very much) response scale. Items are aggregated to a single score on a 0-60 scale.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Symptom scale/item higher score represents a high level of symptomatic problem.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Symptom scale/item higher score represents a high level of symptomatic problem.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Symptom scale/item higher score represents a high level of symptomatic problem.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Symptom scale/item higher score represents a high level of symptomatic problem.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Symptom scale/item higher score represents a high level of symptomatic problem.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Symptom scale/item higher score represents a high level of symptomatic problem.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Symptom scale/item higher score represents a high level of symptomatic problem.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Symptom scale/item higher score represents a high level of symptomatic problem.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Time frame: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

A TEAE was defined as an adverse event that started any time from initiation of product administration through and including 90 days following product administration. AEs that occurred after the initiation of subsequent anticancer therapy or product retreatment were not considered as product TEAE. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe, Grade 4= Life-threatening, and 5 = Death.

Time frame: From first dose to 90 days following first dose (up to approximately 90 days)

Population: All participants who received at least one JCAR017 infusion

The numbers of ICU inpatient days.

Time frame: From first dose after JCAR017 infusion to up to approximately 24 months

Population: All participants who received at least one infusion of JCAR017 who were monitored inpatient

Number of non-ICU inpatient days.

Time frame: From first dose after JCAR017 infusion to up to approximately 24 months

Population: All participants who received at least one infusion of JCAR017 who were monitored inpatient

OS is defined as the time from JCAR017 infusion to the date of death. Kaplan-Meier (KM) methodology will be used to analyze OS.

Time frame: From first dose to date of death (up to approximately 24 months)

Population: All participants with PET positive disease who received at least one infusion of JCAR017

Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration.

Time frame: From first dose to up to 24 months

Population: All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR

Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Cmax = Maximum observed blood concentration.

Time frame: From first dose to up to 24 months

Population: All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR

Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Tmax = Time of maximum observed blood concentration.

Time frame: From first dose to up to 24 months

Population: All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR

PFS is defined as the time from JCAR017 infusion to progressive disease (PD) or death. Kaplan-Meier (KM) methodology will be used to analyze PFS. PD = Score 4 or 5b on the positron emission tomography 5-point scale (PET 5PS) with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake \> mediastinum but ≤ liver; 4- uptake moderately \> liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Time frame: From first dose to progressive disease (PD) or death (up to approximately 24 months)

Population: All participants with PET positive disease who received at least one infusion of JCAR017

Length of hospitalization stay was reported for up to 24 months post liso-cel infusion. Reasons for hospitalization include adverse events, prophylaxis, and other. Adverse events were reported for up to 90 days post liso-cel infusion.

Time frame: From first dose after JCAR017 infusion to up to approximately 24 months

Population: All participants who received at least one infusion of JCAR017 who were monitored inpatient