Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma

Conditions

Metastatic Melanoma

Keywords

Autologous Adoptive Cell Transfer, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy, Cell Therapy, Tumor Infiltrating Lymphocytes, TIL, LN-144, IL-2, Melanoma, Lifileucel

Brief summary

Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen.

Detailed description

Lifileucel is an autologous adoptive cell transfer therapy that utilizes a TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with metastatic melanoma. The adoptive cell transfer therapy used in this study involves patients receiving a lymphocyte depleting preconditioning regimen, prior to infusion of autologous TIL, followed by the administration of a regimen of IL-2.

Theresa Medina, Jason Chesney, Harriet M. Kluger, Omid Hamid, Eric D. Whitman et al. (20 authors)

Journal of Clinical Oncology2025-05-281 citations

10.1200/jco.2025.43.16_suppl.9515

Recent Advancements in Cell-Based Therapies in Melanoma.

Nassief G, Anaeme A, Moussa K, Mansour AN, Ansstas G.

2024-09-124 citations

10.3390/ijms25189848

Dynamics of circulating cytokines and chemokines during and after tumor-infiltrating lymphocyte cell therapy with lifileucel in advanced melanoma patients.

Rongsu Qi, Amod A. Sarnaik, John M. Kirkwood, James Larkin, Jeffrey S. Weber et al. (11 authors)

Journal of Clinical Oncology2024-06-011 citations

10.1200/jco.2024.42.16_suppl.9594

119O Long-term efficacy and patterns of response of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: A 4-year analysis of the C-144-01 study

Theresa Medina, Jason Chesney, Eric D. Whitman, Harriet M. Kluger, Sajeve Thomas et al. (18 authors)

Immuno-Oncology Technology2023-12-0110 citations

10.1016/j.iotech.2023.100591

776 Long-term efficacy and safety of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: a 4-year analysis of the C-144–01 study

Theresa Medina, Jason Chesney, Eric D. Whitman, Harriet M. Kluger, Sajeve Thomas et al. (18 authors)

Regular and Young Investigator Award Abstracts2023-10-318 citations

10.1136/jitc-2023-sitc2023.0776

789 Lifileucel TIL cell monotherapy in patients with advanced melanoma after progression on immune checkpoint inhibitors (ICI) and targeted therapy: pooled analysis of consecutive cohorts (C-144–01 study)

Amod Sarnaik, Karl D. Lewis, Harriet M. Kluger, Omid Hamid, Eric D. Whitman et al. (25 authors)

Regular and Young Investigator Award Abstracts2022-11-015 citations

10.1136/jitc-2022-sitc2022.0789

Tumor mutational burden (TMB) in immune checkpoint inhibitor (ICI)-naïve and -experienced patients with metastatic melanoma treated with lifileucel, a tumor-infiltrating lymphocyte (TIL) cell therapy.

Harriet M. Kluger, Amod A. Sarnaik, Jason Chesney, Karl D. Lewis, Jeffrey S. Weber et al. (19 authors)

Journal of Clinical Oncology2022-06-014 citations

10.1200/jco.2022.40.16_suppl.9524

Abstract CT008: Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced (unresectable or metastatic) melanoma: durable duration of response at 28 month follow up

Jason Chesney, James Larkin, John M. Kirkwood, Jeffrey S. Weber, Nikhil I. Khushalani et al. (22 authors)

Cancer Research2021-07-015 citations

10.1158/1538-7445.am2021-ct008

Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma: Evaluation of impact of prior anti-PD-1 therapy.

James Larkin, Amod A. Sarnaik, Jason Chesney, Nikhil I. Khushalani, John M. Kirkwood et al. (20 authors)

Journal of Clinical Oncology2021-05-2023 citations

10.1200/jco.2021.39.15_suppl.9505

Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies.

Amod A. Sarnaik, Nikhil I. Khushalani, Jason Chesney, Karl D. Lewis, Theresa Medina et al. (20 authors)

Journal of Clinical Oncology2020-05-2037 citations

10.1200/jco.2020.38.15_suppl.10006

P865 Safety & efficacy of lifileucel (LN-144) tumor infiltrating lymphocyte therapy in metastatic melanoma patients after progression on multiple therapies – independent review committee data update

Amod Sarnaik, Nikhil I. Khushalani, Jason Chesney, Harriet M. Kluger, Brendan D. Curti et al. (25 authors)

Poster presentations2020-04-013 citations

10.1136/lba2019.18

Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients who progressed on multiple prior therapies including anti-PD-1.

Amod Sarnaik, Nikhil I. Khushalani, Jason Chesney, Harriet M. Kluger, Brendan D. Curti et al. (18 authors)

Journal of Clinical Oncology2019-05-2031 citations

10.1200/jco.2019.37.15_suppl.2518

Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients previously treated with at least one prior systemic therapy.

Amod Sarnaik, Sajeve Thomas, Diwakar Davar, John M. Kirkwood, Harriet M. Kluger et al. (19 authors)

Journal of Clinical Oncology2019-03-103 citations

10.1200/jco.2019.37.8_suppl.136

Abstract CT169: A phase II, multicenter study to assess the efficacy and safety of autologous tumor infiltrating lymphocytes (LN-144) for treatment of patients with metastatic melanoma

Amod A. Sarnaik, Brendan D. Curti, Diwakar Davar, Omid Hamid, Jose Lutzky et al. (18 authors)

Cancer Research2018-07-011 citations

10.1158/1538-7445.am2018-ct169

A phase 2, multicenter study to assess the efficacy and safety of autologous tumor-infiltrating lymphocytes (LN-144) for the treatment of patients with metastatic melanoma.

Amod Sarnaik, Brendan D. Curti, Diwakar Davar, John M. Kirkwood, Omid Hamid et al. (19 authors)

Journal of Clinical Oncology2018-05-202 citations

10.1200/jco.2018.36.15_suppl.tps9595

Efficacy of single administration of tumor-infiltrating lymphocytes (TIL) in heavily pretreated patients with metastatic melanoma following checkpoint therapy.

Amod A. Sarnaik, Harriet M. Kluger, Jason Chesney, Jyothi Sethuraman, Anandharamen Veerapathran et al. (14 authors)

Journal of Clinical Oncology2017-05-209 citations

10.1200/jco.2017.35.15_suppl.3045

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

BIOLOGICALLifileucel

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for participation in the study: Criteria for Inclusion: 1. Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV) 2. Patients must have progressed following ≥ one prior systemic therapy including a programmed cell death protein-1 (PD-1) blocking antibody; and if proto-oncogene B-Raf (BRAF) V600 mutation-positive, a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor 3. At least one measurable target lesion, as defined by RECIST v1.1 * Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was ≥ 3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion 4. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days) 5. Patients must be ≥ 18 years of age at the time of consent. Enrollment of patients \> 70 years of age may be allowed after consultation with the Medical Monitor 6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months 7. In the opinion of the Investigator, patients must be able to complete all study-required procedures 8. Patients must have the following hematologic parameters: * Absolute neutrophil count (ANC) ≥ 1000/mm3 * Hemoglobin (Hb) ≥ 9.0 g/dL * Platelet ≥ 100,000/mm3 9. Patients must have adequate organ function: * Serum alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) and aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 times the upper limit of normal (ULN); patients with liver metastasis ≤ 5 times ULN * Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula * Total bilirubin ≤ 2 mg/dL * Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg/dL 10. Patients must have recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \[CTCAE\] v4.03), except for alopecia or vitiligo, prior to Enrollment (tumor resection) * Patients with documented ≥ Grade 2 diarrhea or colitis as a result of previous treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least 6 months and/or had a normal colonoscopy post-immune checkpoint inhibitor treatment, by visual assessment, prior to tumor resection 11. Patients must have a washout period ≥ 28 days from prior anticancer therapy(ies) to the start of the planned NMA-LD preconditioning regimen: * Targeted therapy: MEK/BRAF or other targeted agent * Chemotherapy * Immunotherapy: anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)/anti-PD-1, other monoclonal antibody (mAb), or vaccine * Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL, or as target or non-target lesions. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v4.03 12. Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy * Approved methods of birth control are as follows: * Combined (estrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal * Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomized partner * True sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) is not acceptable 13. Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period 14. Patients have provided written authorization for use and disclosure of protected health information Criteria for Exclusion: Patients who meet any of the following criteria are not eligible for participation in this study: 1. Patients who have been shown to be BRAF mutation positive (V600), but have not received prior systemic therapy with a BRAF inhibitor alone or a BRAF inhibitor in combination with a MEK inhibitor 2. Patients who have received an organ allograft or prior cell transfer therapy 3. Patients with melanoma of uveal/ocular origin 4. Patients who have a history of hypersensitivity to any component or excipient of LN-144 or other study drugs: * NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine) * Antibiotics (ABX) of the aminoglycoside group (ie, streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity * Any component of the LN-144 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40 5. Patients with symptomatic and/or untreated brain metastases (of any size and any number) * Patients with definitively treated brain metastases may be considered for Enrollment, and must be stable for ≥ 14 days prior to beginning the NMA LD preconditioning regimen 6. Patients who are on chronic systemic steroid therapy for any reason 7. Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system 8. Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease \[SCID\] and acquired immunodeficiency syndrome \[AIDS\]) 9. Patients who have a left ventricular ejection fraction (LVEF) \< 45% or New York Heart Association (NYHA) functional classification \> Class 1 * Patients ≥ 60 years of age and who have a history of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias must have a cardiac stress test. Patients with any irreversible wall movement abnormalities are excluded 10. Patients who have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60% 11. Patients who have had another primary malignancy within the previous 3 years (with the exception of carcinoma in situ of the breast, cervix, or bladder; localized prostate cancer; and non-melanoma skin cancer that has been adequately treated) 12. Patients who have received a live or attenuated vaccine within 28 days of beginning the NMA-LD preconditioning regimen 13. Patients who are pregnant or breastfeeding 14. Patients whose cancer requires immediate attention or who would otherwise suffer a disadvantage by participating in this trial 15. Patients protected by the following constraints: * Hospitalized persons without consent or persons deprived of liberty because of a judiciary or administrative decision * Adult persons with a legal protection measure or persons who cannot express their consent * Patients in emergency situations who cannot consent to participate in the trial

Design outcomes

Primary

Measure	Time frame	Description
Disease Assessment for Objective Response Rate	Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months	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

Secondary

Measure	Time frame	Description
Disease Assessment for Duration of Response	Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months	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
Disease Assessment for Disease Control Rate	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
Disease Assessment for Progression-Free Survival	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
Overall Survival	Until death or up to 60 months	Evaluate overall survival (OS)
Safety Profile	Maximum 60 months	Incidence, seriousness, relationship to study treatment, and characteristics of treatment-emergent adverse events

Countries

France, Germany, Hungary, Italy, Spain, Switzerland, United Kingdom, United States

Contacts

STUDY_CHAIRIovance Biotherapeutics Medical Monitor

Iovance Biotherapeutics, Inc.

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
Cohort 1 Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)	23
Cohort 2 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)	67
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)	12
Cohort 4 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)	89
Total	191

Baseline characteristics

Characteristic	Cohort 2	Cohort 1	Cohort 3	Cohort 4	Total
Age, Categorical Initial Treatment <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Initial Treatment >=65 years	14 Participants	2 Participants	0 Participants	23 Participants	39 Participants
Age, Categorical Initial Treatment Between 18 and 65 years	53 Participants	21 Participants	0 Participants	66 Participants	140 Participants
Age, Categorical Retreatment <=18 years	—	—	0 Participants	—	0 Participants
Age, Categorical Retreatment >=65 years	—	—	1 Participants	—	1 Participants
Age, Categorical Retreatment Between 18 and 65 years	—	—	11 Participants	—	11 Participants
Age, Continuous Initial Treatment	55 Years	52 Years	—	58 Years	56 Years
Age, Continuous Retreatment	—	—	52 Years	—	52 Years
Ethnicity (NIH/OMB) Initial Treatment Hispanic or Latino	5 Participants	2 Participants	0 Participants	3 Participants	10 Participants
Ethnicity (NIH/OMB) Initial Treatment Not Hispanic or Latino	55 Participants	21 Participants	0 Participants	85 Participants	161 Participants
Ethnicity (NIH/OMB) Initial Treatment Unknown or Not Reported	7 Participants	0 Participants	0 Participants	1 Participants	8 Participants
Ethnicity (NIH/OMB) Retreatment Hispanic or Latino	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Ethnicity (NIH/OMB) Retreatment Not Hispanic or Latino	0 Participants	0 Participants	10 Participants	0 Participants	10 Participants
Ethnicity (NIH/OMB) Retreatment Unknown or Not Reported	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Initial Treatment American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Initial Treatment Asian	2 Participants	0 Participants	0 Participants	1 Participants	3 Participants
Race (NIH/OMB) Initial Treatment Black or African American	1 Participants	0 Participants	0 Participants	2 Participants	3 Participants
Race (NIH/OMB) Initial Treatment More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Initial Treatment Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Initial Treatment Unknown or Not Reported	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Initial Treatment White	64 Participants	23 Participants	0 Participants	85 Participants	172 Participants
Race (NIH/OMB) Retreatment American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Retreatment Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Retreatment Black or African American	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Race (NIH/OMB) Retreatment More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Retreatment Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Retreatment Unknown or Not Reported	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Retreatment White	0 Participants	0 Participants	9 Participants	0 Participants	9 Participants
Region of Enrollment France	2 Participants	0 Participants	0 Participants	1 Participants	3 Participants
Region of Enrollment Germany	0 Participants	0 Participants	0 Participants	19 Participants	19 Participants
Region of Enrollment Hungary	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Region of Enrollment Spain	3 Participants	0 Participants	0 Participants	10 Participants	13 Participants
Region of Enrollment Switzerland	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Region of Enrollment United Kingdom	3 Participants	0 Participants	0 Participants	4 Participants	7 Participants
Region of Enrollment United States	56 Participants	23 Participants	0 Participants	55 Participants	134 Participants
Region of Enrollment France	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Region of Enrollment Germany	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Region of Enrollment United Kingdom	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Region of Enrollment United States	0 Participants	0 Participants	8 Participants	0 Participants	8 Participants
Sex: Female, Male Initial Treatment Female	28 Participants	12 Participants	0 Participants	44 Participants	84 Participants
Sex: Female, Male Initial Treatment Male	39 Participants	11 Participants	0 Participants	45 Participants	95 Participants
Sex: Female, Male Retreatment Female	0 Participants	0 Participants	3 Participants	0 Participants	3 Participants
Sex: Female, Male Retreatment Male	0 Participants	0 Participants	9 Participants	0 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	18 / 23	49 / 67	11 / 12	71 / 89
other Total, other adverse events	23 / 23	67 / 67	12 / 12	89 / 89
serious Total, serious adverse events	9 / 23	23 / 67	2 / 12	31 / 89

Outcome results

Primary

Disease Assessment for Objective Response Rate

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

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1	Disease Assessment for Objective Response Rate	4 Participants
Cohort 2	Disease Assessment for Objective Response Rate	23 Participants
Cohort 3	Disease Assessment for Objective Response Rate	1 Participants
Cohort 4	Disease Assessment for Objective Response Rate	25 Participants

Secondary

Disease Assessment for Disease Control Rate

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

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1	Disease Assessment for Disease Control Rate	48 Participants
Cohort 2	Disease Assessment for Disease Control Rate	72 Participants
Cohort 3	Disease Assessment for Disease Control Rate	12 Participants

Secondary

Disease Assessment for Duration of Response

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

Time frame: 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.

Arm	Measure	Value (MEDIAN)
Cohort 1	Disease Assessment for Duration of Response	NA months
Cohort 2	Disease Assessment for Duration of Response	10.4 months
Cohort 3	Disease Assessment for Duration of Response	NA months

Secondary

Disease Assessment for Progression-Free Survival

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

Time frame: 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.

Arm	Measure	Value (MEDIAN)
Cohort 1	Disease Assessment for Progression-Free Survival	4.1 months
Cohort 2	Disease Assessment for Progression-Free Survival	3.9 months
Cohort 3	Disease Assessment for Progression-Free Survival	2.6 months

Secondary

Overall Survival

Evaluate overall survival (OS)

Time frame: Until death or up to 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.

Arm	Measure	Value (MEDIAN)
Cohort 1	Overall Survival	15.6 months
Cohort 2	Overall Survival	12.7 months
Cohort 3	Overall Survival	12.9 months

Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Participant flow

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Disease Assessment for Objective Response Rate

Disease Assessment for Disease Control Rate

Disease Assessment for Duration of Response

Disease Assessment for Progression-Free Survival

Overall Survival