Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a trailblazer in the field of biotechnology focused on developing novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies, has made a groundbreaking announcement. The U.S. Food and Drug Administration (FDA) has approved AMTAGVI (lifileucel) suspension for intravenous infusion, marking a significant milestone in the treatment of adult patients with unresectable or metastatic melanoma. This innovative therapy is designed for patients previously treated with a PD-1 blocking antibody and, if applicable, a BRAF inhibitor with or without a MEK inhibitor. The approval, granted under an accelerated pathway based on overall response rate (ORR) and duration of response, positions AMTAGVI as the first and only one-time, individualized T cell therapy approved for a solid tumor cancer.

AMTAGVI represents a novel approach in cell therapy, utilizing patient-specific TIL cells that naturally target and destroy cancer cells by recognizing unique tumor markers. Manufactured using a proprietary process, AMTAGVI amplifies a patient’s T cells from their tumor, reintroducing billions of these cells back into the body to combat cancer. This method shows promise in addressing the limitations of the body’s natural TIL cells in fighting developed cancers.

Frederick Vogt, Interim Chief Executive Officer and President of Iovance, highlighted the company’s ambition to pioneer the next generation of cell therapy, offering a personalized therapeutic option for patients with advanced melanoma. “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients,” Vogt stated.

The FDA’s approval of AMTAGVI is based on compelling safety and efficacy results from the C-144-01 clinical trial, which showcased deep and durable responses among patients previously treated with anti-PD-1 therapy and, where applicable, targeted therapy. The trial demonstrated a 31.5% objective response rate with a median duration of response not yet reached at 18.6 months follow-up, signifying a substantial advancement in melanoma treatment.

Manufactured at the Iovance Cell Therapy Center (iCTC) in Philadelphia, AMTAGVI’s production capacity is set to meet the needs of several thousand patients annually, with plans for further expansion. This facility stands as the first FDA-approved, centralized, and scalable manufacturing site dedicated to producing TIL cell therapies for patients with solid tumors.

The FDA’s approval of Iovance Biotherapeutics’ AMTAGVI marks a revolutionary step forward in the fight against metastatic melanoma and solidifies the role of cell therapy as a cornerstone of cancer treatment. This approval not only underscores the potential of TIL cell therapy to provide durable and meaningful responses for patients with advanced melanoma but also sets a new benchmark for personalized cancer care. As Iovance continues to explore the application of TIL cell therapy for other solid tumor cancers, AMTAGVI’s success heralds a promising future for the broader application of cell-based immunotherapies, offering new hope to patients facing limited treatment options.

  AMTAGVI, Frederick Vogt, Iovance Biotherapeutics, lifileucel, Melanoma, Solid tumors, US FDA, USA