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Association details:
| Biomarker: | BRAF V600 |
|---|---|
| Cancer: | Melanoma |
| Drug: | Amtagvi (lifileucel) (Immunostimulant, T lymphocyte replacement) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of LN-144 in People With Metastatic Melanoma to the Brain
Excerpt:
...If there is a BRAF V600E/K mutation, the patient must have received prior BRAF+MEK targeted therapy with demonstrated progression of disease....
Source:
Title:
Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
Excerpt:
...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....
Trial ID:
More C2 evidence
Source:
Title:
Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases
Excerpt:
...- stage IV cutaneous melanoma with confirmed progression following at least one or two prior systemic therapies including a programmed cell death protein-1 (PD-1) inhibitor with or without a CTLA-4 inhibitor; and if BRAF V600 mutation-positive, also a BRAF inhibitor or a BRAF inhibitor in combination with a MEK inhibitor....
Trial ID:
Less C2 evidence
Source:
Title:
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.
Published date:
05/19/2021
Excerpt:
C-144-01 is a Phase 2, open-label, multicenter study of efficacy and safety of lifileucel in patients with advanced melanoma who have progressed on anti-PD-1 therapy and BRAFi ± MEKi, if BRAF V600+….Therapy consisted of nonmyeloablative lymphodepletion using 2 days of cyclophosphamide and 5 days of fludarabine, a single infusion of lifileucel, and up to six doses of IL-2....high baseline tumor burden (106 mm mean target lesion SOD)...Median duration of response (mDOR) was not reached at median follow-up of 28 mos (DOR range: 2.2- 35.2 mos).
Secondary therapy:
cyclophosphamide + fludarabine oral
DOI:
10.1200/JCO.2021.39.15_suppl.9505
Trial ID:
