Pilot Immunotherapy Study With Letetresgene Autoleucel (L... | NCT03709706

NCT03709706

Status Module

Sponsor/Collaborators Module

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: lete-cel monotherapy	Experimental	In Arm A, participants with NSCLC (lacking actionable genetic aberrations) will receive lete-cel monotherapy. Participants who subsequently progress by Week 25 will be offered pembrolizumab.	Drug: Lete-cel Drug: Pembrolizumab
Arm B: lete-cel plus pembrolizumab	Experimental	In Arm B, participants with NSCLC (lacking actionable genetic aberrations) will receive lete-cel followed by pembrolizumab.	Drug: Lete-cel Drug: Pembrolizumab
Arm C: lete-cel plus pembrolizumab	Experimental	In Arm C, participants with NSCLC (with actionable genetic aberrations) will receive lete-cel followed by pembrolizumab.	Drug: Lete-cel Drug: Pembrolizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lete-cel	Drug	lete-cel will be administered to eligible participants.	Arm A: lete-cel monotherapy Arm B: lete-cel plus pembrolizumab Arm C: lete-cel plus pembrolizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent.	Up to approximately 10 months
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)	AESI included cytokine release syndrome (CRS), pneumonitis/pneumonia, graft vs host disease (GvHD), guillain barre syndrome (GBS) or acute inflammatory demyelinating polyneuropathy (AIDP), pancytopenia/aplastic anemia (including analysis of all hematopoietic cytopenias), immune effector cell-associated neurotoxicity syndrome (ICANS) and treatment-related inflammatory response at tumor site. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent.	Up to approximately 10 months
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades	An AE is any untoward medical occurrence in a clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs which start or worsen on or after T-cell infusion are defined as TE. Severity was reported during study and was assigned a grade according to the National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). SAEs are subset of AEs. AEs and SAEs severity graded on a 5-point scale as: 1 = mild, 2 = moderate discomfort, 3 = severe, 4 = life-threatening and 5 = death due to AE.

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) Per RECIST Version 1.1 by Investigator Assessment	Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >=18 years on the day of signing informed consent.
Histologically or cytologically diagnosed unresectable Stage IIIb or Stage IV NSCLC.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Participant is positive for any of the following alleles: human leukocyte antigen (HLA)-A*02:01, HLA-A*02:05, and a) or HLA-A*02:06 by a validated test.
Participant's tumor meets the pre-defined threshold for expression of NY-ESO-1 and/or LAGE-1a.
Adequate organ function and blood cell counts, as defined in the protocol.
Predicted life expectancy that is >=24 weeks from leukapheresis.
Left ventricular ejection fraction >=45%.
Prior therapies prior to lymphodepletion: a) All participants with NSCLC lacking actionable genetic aberrations, per National Comprehensive Cancer Network (NCCN) guidelines (Arms A and B), need to have received at least one line of programmed death protein 1/programmed death protein 1 ligand (PD-1/PD-L1) checkpoint blockade therapy. For participants in the metastatic setting, PD-1/PD-L1 checkpoint blockade therapy must have been received either alone, in combination or sequentially with platinum-containing chemotherapy. OR b) All participants with NSCLC with actionable genetic aberrations, per NCCN guidelines (Arm C only), should have received appropriate targeted therapy following NCCN or equivalent country-level guidelines.
Disease progression at time of treatment, as defined in the protocol.
Measurable disease at time of treatment per response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by local site investigator/radiology.

Exclusion Criteria:

Prior treatment: Previous treatment with genetically engineered NY-ESO-1-specific T-cells. Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody. Prior gene therapy using an integrating vector.
Prior allogeneic/autologous bone marrow or solid organ transplantation.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, fludarabine, dimethylsulfoxide (DMSO) or other agents used in the study.
Severe hypersensitivity (>= Grade 3) to pembrolizumab and/or any of its excipients.
Active autoimmune disease that has required systemic treatment in past 2 years.
History of chronic or recurrent (within the last year prior to enrollment) severe autoimmune or active immune-mediated disease requiring steroids or other immunosuppressive treatments.
Uncontrolled intercurrent illness.
Participant has active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Epstein Barr virus (EBV), cytomegalovirus (CMV), syphilis, or human T lymphotropic virus (HTLV), as defined in protocol.
Known psychiatric or substance abuse disorders.
Symptomatic or untreated central nervous system (CNS) metastases.
Radiotherapy that involves the lung (Percentage of normal lung receiving at least 20 Gray [Gy] during radiotherapy [V20] exceeding 30% lung volume or mean heart dose >20 Gy) within 3 months or radiotherapy (including but not limited to palliative radiotherapy) to lung/mediastinum with V20 less than 30% lung volume and with mean heart dose <=20 Gy within 4 weeks (+/- 3 days).
Radiotherapy of >=50 Gy to a significant volume of the pelvis, long bones or spine, or a cumulative dose of radiation that, in the investigator's opinion would predispose participants to prolonged cytopenia after lymphodepletion.
All of the participant's measurable lesions have been irradiated within 3 months before lymphodepletion.
Other protocol-defined inclusion/exclusion criteria may apply.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Duarte	California	91010	United States
GSK Investigational Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 4, 2021	Jun 22, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
BG001	Arm C: Lete-cel + Pembrolizumab	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

YEARS

Title

Denominators

Categories

Title	Measurements
	BG00062.1± 8.90 BG00159.4± 10.25 BG00261.0± 9.42

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0008 BG0019 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent.

Modified Intent-to-Treat (mITT) population included all participants who received Lete-cel infusion.

Posted

Count of Participants

Participants

Up to approximately 10 months

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
OG001	Arm C: Lete-cel + Pembrolizumab	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

Units	Counts
Participants	OG0007 OG0016

Title

Denominators

Categories

AEs

Title	Measurements
	OG0007 OG0016

SAEs

Title	Measurements
	OG000

Primary

Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)

AESI included cytokine release syndrome (CRS), pneumonitis/pneumonia, graft vs host disease (GvHD), guillain barre syndrome (GBS) or acute inflammatory demyelinating polyneuropathy (AIDP), pancytopenia/aplastic anemia (including analysis of all hematopoietic cytopenias), immune effector cell-associated neurotoxicity syndrome (ICANS) and treatment-related inflammatory response at tumor site. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent.

Modified Intent to Treat (mITT) population.

Posted

Count of Participants

Participants

Up to approximately 10 months

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
OG001

Primary

Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades

An AE is any untoward medical occurrence in a clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs which start or worsen on or after T-cell infusion are defined as TE. Severity was reported during study and was assigned a grade according to the National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). SAEs are subset of AEs. AEs and SAEs severity graded on a 5-point scale as: 1 = mild, 2 = moderate discomfort, 3 = severe, 4 = life-threatening and 5 = death due to AE.

Modified intent-to-treat (mITT) population

Posted

Count of Participants

Participants

Up to approximately 10 months

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

Primary

Number of Participants With AEs Leading to Dose Delays

Modified intent-to-treat (mITT) population

Posted

Count of Participants

Participants

Up to approximately 10 months

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
OG001	Arm C: Lete-cel + Pembrolizumab	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

Primary

Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment

Overall response rate (ORR) defined as the percentage of participants with a complete response (CR) or partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria in Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.

Modified intent-to-treat (mITT) population

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 10 months

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

Secondary

Progression-free Survival (PFS) Per RECIST Version 1.1 by Investigator Assessment

Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.

Modified intent-to-treat (mITT) population

Posted

Median

95% Confidence Interval

Months

Up to approximately 10 months

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

Secondary

Disease Control Rate (DCR) Per RECIST Version 1.1 by Investigator Assessment

DCR was defined as the percentage of participants with a confirmed complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months as per RECIST v1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.

Modified intent-to-treat (mITT) population

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 10 months

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

Secondary

Duration of Response (DOR) Per RECIST Version 1.1 by Investigator Assessment

Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters.

Modified intent-to-treat (mITT) population. Only participants with CR or PR were included in the analysis. No participant achieved CR or PR, hence the number of participants analyzed is 0.

Posted

Up to approximately 10 months

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

Secondary

Time to Response (TTR) Per RECIST Version 1.1 by Investigator Assessment

Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm.

Modified intent-to-treat (mITT) population. Only participants with CR or PR were included in the analysis. No participant achieved CR or PR, hence the number of participants analyzed is 0.

Posted

Up to approximately 10 months

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

Secondary

Maximum Transgene Expansion (Cmax) of Lete-cel

Cmax was defined as peak cell expansion during the study. Blood samples were collected for analysis of Cmax of lete-cel.

Pharmacokinetic (PK) population included all participants in the mITT population from whom at least one PK sample was obtained, analyzed, and was measurable.

Posted

Geometric Mean

Geometric Coefficient of Variation

Copies per microgram genomic DNA

Day 1 to Day 15

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
OG001	Arm C: Lete-cel + Pembrolizumab	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

Secondary

Time to Cmax (Tmax) of Lete-cel

Tmax was defined as time to reach peak cell expansion during the study. Blood samples were collected for analysis of Tmax of lete-cel.

Pharmacokinetic (PK) population

Posted

Median

Full Range

Days

Day 1 to Day 15

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
OG001	Arm C: Lete-cel + Pembrolizumab	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

Secondary

Area Under the Plasma Concentration-time Curve to Day 28 (AUC0-28d) of Lete-cel

Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days).

Pharmacokinetic (PK) population

Posted

Geometric Mean

Geometric Coefficient of Variation

Days*copies per microgram genomic DNA

Up to 28 days

ID	Title	Description
OG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
OG001	Arm C: Lete-cel + Pembrolizumab	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Lete-cel Monotherapy	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.	3	7	5	7	7	7
EG001	Arm C: Lete-cel + Pembrolizumab	Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.	1	6	4	6	6	6
EG002	No Treatment	Participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy or T-cell infusion.	5	21	2	21	3	21

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancytopenia	Blood and lymphatic system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Pericardial effusion	Cardiac disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Nausea	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Pancreatitis	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Small intestinal obstruction	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events1 affected6 at risk EG0020 events0 affected21 at risk
Vomiting	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Fatigue	General disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Cytokine release syndrome	Immune system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Bacteraemia	Infections and infestations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Biliary tract infection	Infections and infestations	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Empyema	Infections and infestations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Pneumonia	Infections and infestations	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Urinary tract infection	Infections and infestations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Infusion related reaction	Injury, poisoning and procedural complications	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Blood bilirubin increased	Investigations	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events1 affected6 at risk EG0020 events0 affected21 at risk
Hyponatraemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Immune effector cell-associated neurotoxicity syndrome	Nervous system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Acute kidney injury	Renal and urinary disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0021 events1 affected21 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0021 events1 affected21 at risk
Cerebrovascular accident	Nervous system disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0021 events1 affected21 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	V25.1	Systematic Assessment	EG0006 events5 affected7 at risk EG0015 events5 affected6 at risk EG0021 events1 affected21 at risk
Leukopenia	Blood and lymphatic system disorders	V25.1	Systematic Assessment	EG0003 events2 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Lymphopenia	Blood and lymphatic system disorders	V25.1	Systematic Assessment	EG0003 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Neutropenia	Blood and lymphatic system disorders	V25.1	Systematic Assessment	EG0003 events3 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Pancytopenia	Blood and lymphatic system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Thrombocytopenia	Blood and lymphatic system disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Atrial flutter	Cardiac disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Sinus tachycardia	Cardiac disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Tachycardia	Cardiac disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Hyperthyroidism	Endocrine disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Dry eye	Eye disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Lacrimation increased	Eye disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Abdominal discomfort	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Abdominal pain	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Abdominal pain lower	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Abdominal pain upper	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Ascites	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Constipation	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Diarrhoea	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0003 events3 affected7 at risk EG0013 events3 affected6 at risk EG0020 events0 affected21 at risk
Dry mouth	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Dyspepsia	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Dysphagia	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Haematemesis	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Haematochezia	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Lip dry	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Nausea	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0012 events2 affected6 at risk EG0020 events0 affected21 at risk
Oral disorder	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Salivary hypersecretion	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Stomatitis	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Vomiting	Gastrointestinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events3 affected6 at risk EG0020 events0 affected21 at risk
Asthenia	General disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0012 events1 affected6 at risk EG0020 events0 affected21 at risk
Chills	General disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Face oedema	General disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Facial pain	General disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Fatigue	General disorders	V25.1	Systematic Assessment	EG0004 events4 affected7 at risk EG0012 events2 affected6 at risk EG0021 events1 affected21 at risk
Malaise	General disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Mucosal inflammation	General disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Non-cardiac chest pain	General disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Oedema	General disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Oedema peripheral	General disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Pyrexia	General disorders	V25.1	Systematic Assessment	EG0005 events5 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Hypertransaminasaemia	Hepatobiliary disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Cytokine release syndrome	Immune system disorders	V25.1	Systematic Assessment	EG0004 events4 affected7 at risk EG0015 events4 affected6 at risk EG0020 events0 affected21 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Hypersensitivity	Immune system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Conjunctivitis	Infections and infestations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Cytomegalovirus viraemia	Infections and infestations	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Rash pustular	Infections and infestations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Fall	Injury, poisoning and procedural complications	V25.1	Systematic Assessment	EG0002 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Radiation necrosis	Injury, poisoning and procedural complications	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Vascular access complication	Injury, poisoning and procedural complications	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Activated partial thromboplastin time prolonged	Investigations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Alanine aminotransferase increased	Investigations	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0013 events2 affected6 at risk EG0020 events0 affected21 at risk
Aspartate aminotransferase increased	Investigations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0013 events2 affected6 at risk EG0020 events0 affected21 at risk
Blood alkaline phosphatase increased	Investigations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Blood creatinine increased	Investigations	V25.1	Systematic Assessment	EG0006 events2 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Blood fibrinogen decreased	Investigations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Blood fibrinogen increased	Investigations	V25.1	Systematic Assessment	EG0002 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Blood methaemoglobin present	Investigations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
C-reactive protein increased	Investigations	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Haemoglobin decreased	Investigations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
International normalised ratio increased	Investigations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Lymphocyte count decreased	Investigations	V25.1	Systematic Assessment	EG0008 events7 affected7 at risk EG0014 events4 affected6 at risk EG0021 events1 affected21 at risk
Neutrophil count decreased	Investigations	V25.1	Systematic Assessment	EG0004 events3 affected7 at risk EG0014 events4 affected6 at risk EG0020 events0 affected21 at risk
Platelet count decreased	Investigations	V25.1	Systematic Assessment	EG0005 events4 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Serum ferritin increased	Investigations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Urine output decreased	Investigations	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Weight decreased	Investigations	V25.1	Systematic Assessment	EG0003 events2 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
White blood cell count decreased	Investigations	V25.1	Systematic Assessment	EG0007 events6 affected7 at risk EG0013 events2 affected6 at risk EG0020 events0 affected21 at risk
Cachexia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Decreased appetite	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0006 events5 affected7 at risk EG0013 events3 affected6 at risk EG0021 events1 affected21 at risk
Hyperchloraemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Hyperglycaemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Hyperkalaemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Hypervolaemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0002 events1 affected7 at risk EG0011 events1 affected6 at risk EG0021 events1 affected21 at risk
Hypocalcaemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0004 events1 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Hypokalaemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0004 events2 affected7 at risk EG0011 events1 affected6 at risk EG0021 events1 affected21 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0006 events2 affected7 at risk EG0010 events0 affected6 at risk EG0021 events1 affected21 at risk
Hyponatraemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG00012 events4 affected7 at risk EG0012 events2 affected6 at risk EG0020 events0 affected21 at risk
Hypophosphataemia	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Malnutrition	Metabolism and nutrition disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Back pain	Musculoskeletal and connective tissue disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0014 events3 affected6 at risk EG0020 events0 affected21 at risk
Bone pain	Musculoskeletal and connective tissue disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Flank pain	Musculoskeletal and connective tissue disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Groin pain	Musculoskeletal and connective tissue disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected6 at risk EG0020 events0 affected21 at risk
Myalgia	Musculoskeletal and connective tissue disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Neck pain	Musculoskeletal and connective tissue disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Sacral pain	Musculoskeletal and connective tissue disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Cognitive disorder	Nervous system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Dizziness	Nervous system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Dysarthria	Nervous system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Dysgeusia	Nervous system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Headache	Nervous system disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0013 events2 affected6 at risk EG0021 events1 affected21 at risk
IIIrd nerve paralysis	Nervous system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Immune effector cell-associated neurotoxicity syndrome	Nervous system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Intraventricular haemorrhage	Nervous system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Paraesthesia	Nervous system disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0021 events1 affected21 at risk
Seizure	Nervous system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Somnolence	Nervous system disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Subarachnoid haemorrhage	Nervous system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Tremor	Nervous system disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Depression	Psychiatric disorders	V25.1	Systematic Assessment	EG0003 events3 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Hallucination	Psychiatric disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Insomnia	Psychiatric disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0011 events1 affected6 at risk EG0021 events1 affected21 at risk
Persistent depressive disorder	Psychiatric disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Acute kidney injury	Renal and urinary disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Chronic kidney disease	Renal and urinary disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Haematuria	Renal and urinary disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Oliguria	Renal and urinary disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Urinary incontinence	Renal and urinary disorders	V25.1	Systematic Assessment	EG0002 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Urinary retention	Renal and urinary disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Cough	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0003 events2 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0004 events3 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0002 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected6 at risk EG0020 events0 affected21 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Alopecia	Skin and subcutaneous tissue disorders	V25.1	Systematic Assessment	EG0004 events4 affected7 at risk EG0013 events3 affected6 at risk EG0020 events0 affected21 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Dry skin	Skin and subcutaneous tissue disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Night sweats	Skin and subcutaneous tissue disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Pruritus	Skin and subcutaneous tissue disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Rash	Skin and subcutaneous tissue disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	V25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0013 events3 affected6 at risk EG0020 events0 affected21 at risk
Rash morbilliform	Skin and subcutaneous tissue disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Haematoma	Vascular disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk
Hypotension	Vascular disorders	V25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected21 at risk
Orthostatic hypotension	Vascular disorders	V25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected21 at risk

First MCP Posted Date

ID	Term
D009369	Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
C582435	pembrolizumab