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LN-145
i
Other names: LN-145, LN145, LN 145, autologous TILs LN-145, autologous expanded tumour infiltrating lymphocytes, TIL LN-145
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Company:
Iovance Biotherap
Drug class:
Immunostimulant
Related drugs:
15d
A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma (clinicaltrials.gov)
P1, N=20, Recruiting, Memorial Sloan Kettering Cancer Center | N=10 --> 20
Enrollment change • Metastases
|
Amtagvi (lifileucel) • LN-145
1m
Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients with Cervical Carcinoma (clinicaltrials.gov)
P2, N=189, Active, not recruiting, Iovance Biotherapeutics, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
|
Keytruda (pembrolizumab) • LN-145
3ms
Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants (clinicaltrials.gov)
P1, N=40, Recruiting, Iovance Biotherapeutics, Inc.
New P1 trial
|
Amtagvi (lifileucel) • LN-145
6ms
NCI-2018-00918: LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas (clinicaltrials.gov)
P2, N=30, Active, not recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Jun 2024 --> Jun 2025 | Trial completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8) • CD28 (CD28 Molecule) • CD27 (CD27 Molecule)
|
CD8 expression • CD28 expression
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • LN-145 • LN-145-S1
6ms
IOV-LUN-202: Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov)
P2, N=170, Recruiting, Iovance Biotherapeutics, Inc. | Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Jun 2024 --> Dec 2030
Trial completion date • Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
cyclophosphamide • LN-145
7ms
IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov)
P2, N=178, Recruiting, Iovance Biotherapeutics, Inc. | Trial completion date: Dec 2024 --> Aug 2029 | Trial primary completion date: Dec 2023 --> Aug 2029
Trial completion date • Trial primary completion date
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • Amtagvi (lifileucel) • LN-145 • LN-145-S1
8ms
Lifileucel, an Autologous Tumor-infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors. (PubMed, Cancer Discov)
In this phase 2 multicenter study, we evaluated the efficacy and safety of lifileucel (LN-145), an autologous tumor-infiltrating lymphocyte cell therapy, in patients with metastatic non-small cell lung cancer (mNSCLC) who had received prior immunotherapy and progressed on their most recent therapy. Two patients died of treatment-emergent adverse events: cardiac failure and multiple organ failure. Lifileucel is a potential treatment option for patients with mNSCLC refractory to prior therapy.
Clinical • Journal • Checkpoint inhibition • Tumor mutational burden • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker • Metastases
|
TMB (Tumor Mutational Burden) • STK11 (Serine/threonine kinase 11)
|
STK11 mutation • PD-L1 negative • TMB-L • PD-L1 negative + TMB-L
|
Amtagvi (lifileucel) • LN-145
9ms
Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=6, Completed, Yale University | Trial completion date: Jan 2023 --> May 2023
Trial completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • ER negative • PGR negative
|
LN-145
1year
Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck (clinicaltrials.gov)
P2, N=64, Completed, Iovance Biotherapeutics, Inc. | N=112 --> 64
Enrollment change • Metastases
|
LN-145 • LN-145-S1
1year
IOV-LUN-202: Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov)
P2, N=170, Recruiting, Iovance Biotherapeutics, Inc. | N=95 --> 170
Enrollment change • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
cyclophosphamide • LN-145
over1year
Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=6, Completed, Yale University | Active, not recruiting --> Completed | Trial completion date: Jul 2023 --> Jan 2023 | Trial primary completion date: Jul 2023 --> Jan 2023
Trial completion • Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • ER negative • PGR negative
|
LN-145
over1year
NCI-2018-00918: LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas (clinicaltrials.gov)
P2, N=30, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=95 --> 30
Enrollment closed • Enrollment change
|
HER-2 (Human epidermal growth factor receptor 2)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • LN-145 • LN-145-S1
over1year
NCI-2018-00918: LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas (clinicaltrials.gov)
P2, N=95, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Jun 2023 --> Jun 2024
Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • LN-145 • LN-145-S1
almost2years
Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=6, Active, not recruiting, Yale University | Recruiting --> Active, not recruiting | N=10 --> 6
Enrollment closed • Enrollment change • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • ER negative • PGR negative
|
LN-145
over2years
Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=10, Recruiting, Yale University | Trial completion date: Jan 2022 --> Jul 2023 | Trial primary completion date: Jan 2022 --> Jul 2023
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • ER negative • PGR negative
|
LN-145
over2years
Trial in Progress: A Phase 2 Multicenter Study (IOV-LUN-202) of Autologous Tumor-infiltrating Lymphocyte (TIL) Cell Therapy (LN-145) in mNSCLC (IASLC-WCLC 2022)
Introduction: Patients with mNSCLC without actionable driver mutations have limited treatment options after progression on concurrent or sequential front-line immune checkpoint inhibitors (ICI) and platinum-based chemotherapy ± bevacizumab. Upon disease progression, patients receive nonmyeloablative lymphodepletion with cyclophosphamide (2 doses at 60 mg/kg) and fludarabine (5 doses at 25 mg/m2), followed by LN-145 infusion (1-150 × 109 cells) and up to 6 doses of IL-2 (600,000 IU/kg). The primary endpoint is ORR assessed by IRC per RECIST v1.1; secondary endpoints include complete response rate, duration of response, disease control rate, progression-free survival, overall survival, and safety (incidence of Grade ≥3 treatment-emergent adverse events [AEs] and serious AEs).
Clinical • P2 data • Tumor-Infiltrating Lymphocyte • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
KRAS mutation • EGFR mutation • PD-L1 negative
|
Avastin (bevacizumab) • cyclophosphamide • fludarabine IV • LN-145
over2years
IOV-LUN-202: Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov)
P2, N=95, Recruiting, Iovance Biotherapeutics, Inc. | Trial primary completion date: Dec 2022 --> Jun 2024
Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
cyclophosphamide • LN-145
over3years
Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=10, Recruiting, Yale University | Suspended --> Recruiting
Clinical • Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • ER negative • PGR negative
|
LN-145
almost4years
Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=10, Suspended, Yale University | Recruiting --> Suspended
Clinical • Trial suspension
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • ER negative • PGR negative
|
LN-145
almost4years
IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov)
P2, N=135, Recruiting, Iovance Biotherapeutics, Inc. | N=75 --> 135
Clinical • Enrollment change • PD(L)-1 Biomarker
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK mutation
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • Amtagvi (lifileucel) • LN-145 • LN-145-S1
almost4years
Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov)
P2, N=95, Recruiting, Iovance Biotherapeutics, Inc. | Not yet recruiting --> Recruiting
Clinical • Enrollment open • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
LN-145
4years
Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov)
P2, N=95, Not yet recruiting, Iovance Biotherapeutics, Inc.
Clinical • New P2 trial • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
LN-145
almost5years
Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=10, Recruiting, Yale University | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • ER negative • PGR negative
|
LN-145
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