For patients with advanced-stage, unresectable or metastatic melanoma who have relapsed on prior systemic therapy, including a PD-1 blocking antibody or a BRAF inhibitor with or without a MEK inhibitor (if they harboured the BRAF V600 mutation), treatment options are scarce. Now, new hope is on the horizon, as the FDA has provisionally approved the first tumour-derived T-cell immunotherapy for patients with melanoma. This approval is the first T-cell based immunotherapy for solid tumours, which is in contrast to CAR-T therapies that have been approved for treating blood cancers. Amtagvi is a tumour-derived autologous immunotherapy that comprises the patient’s own engineered T cells. A portion of the patient’s tumour is surgically removed before treatment and the T cells are then separated from the tumour, further manufactured and re-administered back into the patient as a single infusion. In this single-arm, multi-cohort trial of 73 patients with unresectable metastatic melanoma, the objective response rate was 31.5%. In those who responded, the responses were maintained without disease progression in 56.5%, 47.8% and 43.5% of patients at 6, 9 and 12 months, respectively. A cautionary note, however, because all CAR-T therapies must carry a boxed warning owing to concerns of secondary malignancies. Thus, larger follow-up data and careful safety monitoring are needed before Amtagvi becomes an established treatment approach; a confirmatory trial is underway to confirm these findings.
Amtagvi – first cellular therapy approval for unresectable melanoma
