Trial Outcomes & Findings for Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma (NCT NCT02360579)

Last Updated: 2025-12-09

Results Overview

Evaluate the efficacy of LN-144 in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for Cohorts 1 \& 3 and as assessed by Independent Review Committee (IRC) per RECIST Version 1.1 for Cohorts 2 \& 4

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

220 participants

Primary outcome timeframe

Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months

Results posted on

2025-12-09

Participant Flow

Cohorts 1, 2, 4 refers to the initial treatment. Cohort 3 patients had progressed following the initial treatment and then were retreated with a second TIL regimen. Data are captured in the retreatment period for Cohort 3.

Participant milestones

Participant milestones
Measure	Cohort 1 Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 2 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 3 Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 4 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
Initial STARTED	31	78	0	111
Initial Patients Infused With TIL	23	67	0	89
Initial COMPLETED	0	14	0	14
Initial NOT COMPLETED	31	64	0	97
Retreatment STARTED	0	0	12	0
Retreatment COMPLETED	0	0	1	0
Retreatment NOT COMPLETED	0	0	11	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 2 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 3 Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 4 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
Initial Death	16	49	0	71
Initial Lost to Follow-up	0	4	0	1
Initial Withdrawal by Subject	0	0	0	3
Initial Other	7	0	0	0
Initial Did not receive TIL	8	11	0	22
Retreatment Death	0	0	11	0

Baseline Characteristics

Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=23 Participants Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)	Cohort 2 n=67 Participants Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)	Cohort 3 n=12 Participants Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed)	Cohort 4 n=89 Participants Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)	Total n=191 Participants Total of all reporting groups
Age, Categorical Initial Treatment · <=18 years	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Age, Categorical Initial Treatment · Between 18 and 65 years	21 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	53 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	66 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	140 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Age, Categorical Initial Treatment · >=65 years	2 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	14 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	23 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	39 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Age, Categorical Retreatment · <=18 years	—	—	0 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	—	0 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Age, Categorical Retreatment · Between 18 and 65 years	—	—	11 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	—	11 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Age, Categorical Retreatment · >=65 years	—	—	1 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	—	1 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Age, Continuous Initial Treatment	52 Years n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	55 Years n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	—	58 Years n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	56 Years n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Age, Continuous Retreatment	—	—	52 Years n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	—	52 Years n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Sex: Female, Male Initial Treatment · Female	12 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	28 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	44 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	84 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Sex: Female, Male Initial Treatment · Male	11 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	39 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	45 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	95 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Sex: Female, Male Retreatment · Female	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	3 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	3 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Sex: Female, Male Retreatment · Male	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	9 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	9 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Region of Enrollment France	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	2 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants This is the region of enrollment for retreatment	1 Participants n=12 Participants • This is the region of enrollment for retreatment
Ethnicity (NIH/OMB) Initial Treatment · Hispanic or Latino	2 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	5 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	3 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	10 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Ethnicity (NIH/OMB) Initial Treatment · Not Hispanic or Latino	21 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	55 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	85 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	161 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Ethnicity (NIH/OMB) Initial Treatment · Unknown or Not Reported	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	7 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	8 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Ethnicity (NIH/OMB) Retreatment · Hispanic or Latino	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Ethnicity (NIH/OMB) Retreatment · Not Hispanic or Latino	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	10 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	10 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Ethnicity (NIH/OMB) Retreatment · Unknown or Not Reported	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Initial Treatment · American Indian or Alaska Native	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Initial Treatment · Asian	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	2 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	3 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Initial Treatment · Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Initial Treatment · Black or African American	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	2 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	3 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Initial Treatment · White	23 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	64 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	85 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	172 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Initial Treatment · More than one race	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Initial Treatment · Unknown or Not Reported	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Retreatment · American Indian or Alaska Native	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Retreatment · Asian	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Retreatment · Native Hawaiian or Other Pacific Islander	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Retreatment · Black or African American	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	2 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	2 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Retreatment · White	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	9 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	9 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Retreatment · More than one race	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Race (NIH/OMB) Retreatment · Unknown or Not Reported	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=12 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Region of Enrollment United States	0 Participants This is the region of enrollment for retreatment	0 Participants This is the region of enrollment for retreatment	8 Participants n=12 Participants • This is the region of enrollment for retreatment	0 Participants This is the region of enrollment for retreatment	8 Participants n=12 Participants • This is the region of enrollment for retreatment
Region of Enrollment Germany	0 Participants This is the region of enrollment for retreatment	0 Participants This is the region of enrollment for retreatment	2 Participants n=12 Participants • This is the region of enrollment for retreatment	0 Participants This is the region of enrollment for retreatment	2 Participants n=12 Participants • This is the region of enrollment for retreatment
Region of Enrollment Hungary	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	2 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	2 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Region of Enrollment Spain	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	3 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	10 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	13 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Region of Enrollment Switzerland	0 Participants n=23 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=67 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	0 Participants n=89 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3	1 Participants n=179 Participants • Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
Region of Enrollment United Kingdom	0 Participants This is the region of enrollment for retreatment	0 Participants This is the region of enrollment for retreatment	1 Participants n=12 Participants • This is the region of enrollment for retreatment	0 Participants This is the region of enrollment for retreatment	1 Participants n=12 Participants • This is the region of enrollment for retreatment

PRIMARY outcome

Timeframe: Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months

Population: The Full Analysis Set is defined as patients who received the lifileucel infusion that met product manufacturing specifications. Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen.

Outcome measures

Outcome measures
Measure	Cohort 1 n=20 Participants Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 2 n=66 Participants Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 3 n=10 Participants Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 4 n=87 Participants Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
Disease Assessment for Objective Response Rate	4 Participants	23 Participants	1 Participants	25 Participants

SECONDARY outcome

Timeframe: Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months

Population: The Full Analysis Set is defined as patients who received the lifileucel infusion that met product manufacturing specifications. Due to the small number of patients this outcome measure was not analyzed for Cohort 3 per the statistical analysis plan.

Evaluate the efficacy endpoints of duration of response (DOR) by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1

Outcome measures

Outcome measures
Measure	Cohort 1 n=23 Participants Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 2 n=25 Participants Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 3 n=4 Participants Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 4 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
Disease Assessment for Duration of Response	NA months Insufficient number of participants with events, therefore the Median and 95% Confidence Interval were not reached	10.4 months Interval 4.1 to 26.2	NA months Interval 3.0 to Insufficient number of participants with events, therefore the Median and 95% Confidence Interval were not reached	—

SECONDARY outcome

Timeframe: Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months

Evaluate the efficacy endpoints of disease control rate (DCR) by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1

Outcome measures

Outcome measures
Measure	Cohort 1 n=66 Participants Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 2 n=87 Participants Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 3 n=20 Participants Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 4 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
Disease Assessment for Disease Control Rate	48 Participants	72 Participants	12 Participants	—

SECONDARY outcome

Timeframe: Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months

Evaluate the efficacy endpoints of Progression-Free Survival by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1

Outcome measures

Outcome measures
Measure	Cohort 1 n=66 Participants Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 2 n=87 Participants Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 3 n=20 Participants Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 4 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
Disease Assessment for Progression-Free Survival	4.1 months Interval 2.8 to 8.4	3.9 months Interval 2.8 to 4.9	2.6 months Interval 1.4 to 4.2	—

SECONDARY outcome

Timeframe: Until death or up to 60 months

Evaluate overall survival (OS)

Outcome measures

Outcome measures
Measure	Cohort 1 n=66 Participants Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 2 n=87 Participants Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 3 n=20 Participants Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.	Cohort 4 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
Overall Survival	15.6 months Interval 11.0 to 23.3	12.7 months Interval 8.3 to 17.8	12.9 months Interval 5.3 to 26.1	—

Adverse Events

Cohort 3

Serious events: 2 serious events

Other events: 12 other events

Deaths: 11 deaths

Cohort 4

Serious events: 31 serious events

Other events: 89 other events

Deaths: 71 deaths

Cohort 1

Serious events: 9 serious events

Other events: 23 other events

Deaths: 18 deaths

Cohort 2

Serious events: 23 serious events

Other events: 67 other events

Deaths: 49 deaths

Serious adverse events

Other adverse events

Additional Information

Rana Fiaz, Executive Medical Director

Iovance Biotherapeutics

Phone: 661-645-3572

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Cohort 3 n=12 participants at risk Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b).	Cohort 4 n=89 participants at risk Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)	Cohort 1 n=23 participants at risk Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)	Cohort 2 n=67 participants at risk Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
Blood and lymphatic system disorders Anaemia	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	2.2% 2/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	13.0% 3/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	9.0% 6/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Blood and lymphatic system disorders Neutropenia [1]	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	2.2% 2/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Blood and lymphatic system disorders Thrombocytopenia [2]	16.7% 2/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	3.4% 3/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	13.0% 3/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	6.0% 4/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Cardiac disorders Acute myocardial infarction	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Cardiac disorders Arrhythmia	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Cardiac disorders Atrial fibrillation	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Eye disorders Uveitis	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Ascites	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Colitis	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Haematochezia	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Melaena	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Nausea	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Vomiting	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Chills	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Fatigue	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Pyrexia	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	3.0% 2/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Infections and infestations Pneumonia	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	2.2% 2/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	3.0% 2/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Systemic inflammatory response syndrome	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Immune system disorders Anaphylactic reaction	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	3.0% 2/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Immune system disorders Cytokine release syndrome	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Infections and infestations Device related infection	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Infections and infestations Encephalitis	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Infections and infestations Infection	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Infections and infestations Neutropenic sepsis	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Infections and infestations Sepsis	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Infections and infestations Urinary tract infection	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Infections and infestations Viral infection	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Investigations Alanine aminotransferase increased	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Investigations Aspartate aminotransferase increased	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Investigations Blood bilirubin increased	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Metabolism and nutrition disorders Acidosis	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	3.0% 2/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.

Other adverse events
Measure	Cohort 3 n=12 participants at risk Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b).	Cohort 4 n=89 participants at risk Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)	Cohort 1 n=23 participants at risk Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)	Cohort 2 n=67 participants at risk Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
Blood and lymphatic system disorders Anaemia	91.7% 11/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	60.7% 54/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	78.3% 18/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	68.7% 46/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Blood and lymphatic system disorders Febrile neutropenia	41.7% 5/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	30.3% 27/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	47.8% 11/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	44.8% 30/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Blood and lymphatic system disorders Leukopenia [1]	16.7% 2/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	32.6% 29/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	52.2% 12/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	41.8% 28/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Blood and lymphatic system disorders Lymphopenia [2]	25.0% 3/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	31.5% 28/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	26.1% 6/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	34.3% 23/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Blood and lymphatic system disorders Neutropenia [3]	41.7% 5/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	33.7% 30/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	47.8% 11/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	55.2% 37/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Blood and lymphatic system disorders Normocytic anaemia	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.5% 4/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	3.0% 2/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.5% 4/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	7.5% 5/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Blood and lymphatic system disorders Thrombocytopenia [4]	83.3% 10/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	80.9% 72/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	73.9% 17/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	89.6% 60/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Cardiac disorders Acute myocardial infarction	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Cardiac disorders Atrial fibrillation	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	3.4% 3/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Cardiac disorders Sinus tachycardia	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	14.6% 13/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	26.1% 6/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	14.9% 10/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Cardiac disorders Stress cardiomyopathy	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Cardiac disorders Supraventricular tachycardia	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.5% 3/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Cardiac disorders Tachycardia	50.0% 6/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	24.7% 22/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	13.0% 3/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	34.3% 23/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Ear and labyrinth disorders Deafness bilateral	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Endocrine disorders Adrenal insufficiency	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	8.7% 2/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Eye disorders Uveitis	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	2.2% 2/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.5% 3/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Eye disorders Vision blurred	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.5% 4/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	6.0% 4/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Abdominal distension	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.5% 4/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	8.7% 2/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.5% 4/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	8.7% 2/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	6.0% 4/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	2.2% 2/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	9.0% 6/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Constipation	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	7.9% 7/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	17.4% 4/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	19.4% 13/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Diarrhoea	41.7% 5/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	32.6% 29/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	39.1% 9/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	28.4% 19/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Dry mouth	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	9.0% 8/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	7.5% 5/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Dyspepsia	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	8.7% 2/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	3.0% 2/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Nausea	16.7% 2/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	23.6% 21/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	56.5% 13/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	23.9% 16/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Stomatitis	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.5% 4/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Gastrointestinal disorders Vomiting	16.7% 2/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	22.5% 20/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	39.1% 9/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	20.9% 14/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Asthenia	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	15.7% 14/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	8.7% 2/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	11.9% 8/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Chills	75.0% 9/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	71.9% 64/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	65.2% 15/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	77.6% 52/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Fatigue	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	28.1% 25/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	34.8% 8/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	38.8% 26/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Malaise	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	5.6% 5/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	8.7% 2/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	6.0% 4/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Mucosal inflammation	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.5% 4/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	6.0% 4/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Non-cardiac chest pain	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	2.2% 2/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	8.7% 2/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	3.0% 2/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Oedema	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	9.0% 8/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Oedema peripheral	25.0% 3/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	16.9% 15/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	34.8% 8/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	25.4% 17/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Pain	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	2.2% 2/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.3% 1/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
General disorders Pyrexia	50.0% 6/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	47.2% 42/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	39.1% 9/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	58.2% 39/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Immune system disorders Cytokine release syndrome	8.3% 1/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	4.5% 4/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.5% 1/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
Immune system disorders Hypersensitivity	0.00% 0/12 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	1.1% 1/89 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	8.7% 2/23 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.	0.00% 0/67 • From enrollment to end of follow-up (up to 5 years) Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.