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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:
3ms
Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma (clinicaltrials.gov)
P2, N=210, Terminated, Iovance Biotherapeutics, Inc. | Trial completion date: Dec 2030 --> Aug 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Aug 2025; After reviewing available safety and efficacy data to date, Iovance concluded the study reached the required number of events for evaluation of study endpoints.
Trial completion date • Trial termination • Trial primary completion date
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Keytruda (pembrolizumab) • LN-145
3ms
Efficacy and safety of one-time autologous tumor-infiltrating lymphocyte cell therapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. (PubMed, J Immunother Cancer)
This study demonstrated the feasibility of consistently generating sufficient TIL from HNSCC tumors. Results from this study suggest TIL cell therapy may serve as a potential treatment option for patients with HNSCC and support further development, including TIL cell therapy combined with immune checkpoint inhibitors or other agents or with other TIL products.
Journal • Tumor-infiltrating lymphocyte
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PD-L1 (Programmed death ligand 1) • IL2 (Interleukin 2)
|
Amtagvi (lifileucel) • LN-145 • LN-145-S1
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 completion date: Jun 2025 --> Apr 2027 | Trial primary completion date: Jun 2025 --> Apr 2027
Trial completion date • 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
7ms
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 | Trial completion date: May 2025 --> May 2026 | Trial primary completion date: May 2025 --> May 2026
Trial completion date • Trial primary completion date
|
Amtagvi (lifileucel) • LN-145
8ms
IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov)
P2, N=245, Recruiting, Iovance Biotherapeutics, Inc. | N=178 --> 245
Enrollment change
|
Keytruda (pembrolizumab) • cisplatin • Yervoy (ipilimumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • Opdualag (nivolumab/relatlimab-rmbw) • Amtagvi (lifileucel) • relatlimab (BMS-986016) • LN-145 • LN-145-S1
1year
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
1year
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
over1year
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
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 | 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
over1year
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
over1year
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
over1year
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
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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
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