Iovance’s Amtagvi: First FDA-Approved Tumor-Infiltrating Lymphocyte Therapy

Iovance Biotherapeutics’ (NASDAQ: IOVA) Amtagvi (lifileucel) is an autologous tumor-infiltrating lymphocyte (TIL) therapy that was recently granted FDA accelerated approval for advanced melanoma based on overall response rate (ORR) and duration of response. The FDA requires a confirmatory Phase 3 trial to confirm clinical benefit; IOVA is currently conducting this confirmatory study. Melanoma patients that have previously been treated with an anti-PD-1 antibody or targeted therapy with a BRAF inhibitor (with or without MEK inhibitor) are eligible for Amtagvi. Amtagvi marks the first T cell-based therapy approved for a solid tumor.

Based on Visible Alpha consensus, analysts project 2034 global revenues of $1.8 billion (unadjusted) for advanced melanoma. Amtagvi has a high price tag — a one-time treatment costs $515,000 per patient.

About TILs

Tumor-infiltrating lymphocytes, or TILs, are T cells that have recognized tumor antigen but are rendered ineffective or “exhausted” by the tumor. These TILs can be harvested from the patient, expanded, and rejuvenated ex-vivo and then infused back into the patient. This processing and manufacturing time takes about 34 days. In contrast to CAR T-cell therapy, TILs are not genetically engineered to recognize a specific antigen. TILs are derived from the tumor and already recognize a repertoire of unique tumor antigens. This provides an advantage for TIL therapy since solid tumors have significant heterogeneity that does not cater well to CAR T cell therapy. Similar to CAR T cells, TIL therapy comes with a Boxed Warning.

Sector: Health Care
Industry: Biotechnology
Ticker: IOVA_US