TGA approves first TIL therapy in advanced melanoma

The Therapeutic Goods Administration (TGA) has granted approval for the first individualised tumour-infiltrating lymphocyte (TIL) therapy, Amtagvi (lifileucel), for patients with metastatic or unresectable melanoma who have previously been treated with a PD-1 blocking antibody. For patients with BRAF V600 mutation-positive disease, eligibility also requires prior treatment with a BRAF inhibitor, with or without a MEK inhibitor.

Australia continues to carry the world’s highest melanoma burden, with approximately 17,000 new diagnoses annually and more than 1,500 deaths recorded each year.

“This approval in Australia is our third marketing authorisation for Amtagvi and marks a significant step forward for Iovance in the country with the highest rate of melanoma globally,” said Dr Frederick Vogt, Interim CEO and President of Iovance Biotherapeutics. “We are in the process of authorising our first Australian treatment centre as we advance our expansion strategy for Amtagvi in additional markets with a high prevalence of advanced melanoma.”

Amtagvi has been priced at more than USD $500,000 per patient as a one-time treatment. The regulatory decision is underpinned by data from the global C-144-01 phase 2 clinical trial. In the study, median overall survival (OS) was 13.9 months, and the 5-year OS rate reached 19.7%. A key limitation of the C-144-01 trial was the absence of a comparator arm.

The approval also reflects a broader evolution in cell therapy for solid tumours. Prior to Amtagvi, CAR-T approaches have largely been confined to haematological malignancies, partly due to the lack of suitable cell-surface biomarkers in solid tumours for CAR-T targeting. TIL therapy addresses this limitation by leveraging tumour-infiltrating lymphocytes, which are naturally capable of recognising cancer-associated biomarkers.

Iovance Biotherapeutics is also advancing further clinical development of Amtagvi in treatment-naïve advanced melanoma through the Phase 3 TILVANCE-301 trial. This study evaluates the combination of Amtagvi with MSD’s Keytruda compared with Keytruda monotherapy, alongside exploration in additional solid tumour indications.

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