FDA approves first T cell therapy in solid tumours

T cells attacking cancer

The US Food and Drug Administration has approved Amtagvi (lifileucel), the first cellular therapy indicated for the treatment of metastatic, unresectable melanoma.

It is approved for use in adults that have previously been treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

Amtagvi is the first FDA-approved tumour-derived T cell immunotherapy.

Amtagvi was approved through the Accelerated Approval pathway, which gives patients the opportunity for earlier access to a promising therapy while the company conducts further trials to verify the predicted clinical benefit.

In the C-144-01 clinical trial, among the 73 patients treated with Amtagvi at the recommended dose, the objective response rate was 31.5%, including three (4.1%) patients with a complete response and 20 (27.4%) patients with a partial response.

Among patients who were responsive to the treatment, 56.5%, 47.8% and 43.5% continued to maintain responses without tumour progression or death at six, nine and 12 months, respectively.

Iovance is also conducting TILVANCE-301, a Phase III trial to confirm clinical benefit.

Significant advancements in TIL therapy

“The accelerated approval of Amtagvi is the first step in realising Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumours,” said Frederick Vogt, Interim Chief Executive Officer and President of Iovance.

“This landmark FDA approval reflects significant advancements in tumour-infiltrating lymphocyte (TIL) cell therapy since we initially showed that TIL cells isolated from patients with metastatic melanoma could be expanded in the lab and returned to the patient to mediate cancer regression,” added Steven Rosenberg, Chief, Surgery Branch, National Cancer Institute. “This approval is transformative for the entire research field and supports continued investigation of TIL cell therapy across additional types of solid tumours.”

Amtagvi will be manufactured in Philadelphia at the Iovance Cell Therapy Center (iCTC), with capacity for up to several thousand patients annually, including a nearby contract manufacturer. Additional expansion at iCTC is underway, according to the company, which will significantly increase this capacity over the next few years.

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