SAN CARLOS, Calif. — February 5, 2026 — Leads & Copy — Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) has announced data demonstrating a best-in-class profile for its commercial Amtagvi® (lifileucel), showing unprecedented response rates in a real-world clinical, retrospective study of patients with advanced melanoma.
Amtagvi is a one-time T cell therapy for a solid tumor cancer and the only FDA-approved treatment for advanced melanoma patients previously treated with anti-PD-1 and targeted therapy, where applicable.
The real-world results were presented at the 2026 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT®) and the Center for International Blood and Marrow Transplant Research (CIBMTR®) in Salt Lake City, UT.
The study included 41 evaluable patients with previously treated advanced melanoma who received commercial Amtagvi at four authorized treatment centers. The physician-assessed confirmed objective response rate (ORR) was 44% (18/41), and the disease control rate was 73% (30/41). Response rates were higher with earlier Amtagvi treatment. The ORR was 52% (12/23) following two or fewer lines of therapy, compared to an ORR of 33% (6/18) after three or more lines of therapy. These real-world response rates surpassed the 31% ORR in the C-144-01 clinical trial that supported the FDA accelerated approval of Amtagvi.
Dr. Lilit Karapetyan of H. Lee Moffitt Cancer Center & Research Institute noted that the real-world response rate supports considering lifileucel as soon as possible after immune checkpoint inhibitor treatment. Karapetyan reported an overall response rate of 44% in the full cohort, with a 52% response rate among patients treated in earlier lines of therapy.
Daniel Kirby, Chief Commercial Officer of Iovance, stated that the real world Amtagvi data, paired with five-year durability and survival data, demonstrate a best-in-class profile and better outcomes in patients treated earlier.
Previously treated advanced melanoma represents an unmet medical need with more than 8,000 annual U.S. deaths. More than half of patients treated with first-line standard of care will progress within 12 months.
The FDA granted accelerated approval for Amtagvi in February 2024 based on ORR and duration of response (DOR) from the C-144-01 clinical trial. The published final five-year analysis demonstrated durability and follow-up in previously treated advanced melanoma patients, with ~31% ORR, median DOR of 36+ months, and a 20% five-year overall survival. Iovance is conducting TILVANCE-301, a Phase 3 clinical trial in frontline advanced melanoma, to confirm clinical benefit.
Amtagvi is a prescription medicine used to treat adults with unresectable or metastatic melanoma that has not responded or has stopped responding to a PD-1 blocking drug, and if the cancer is BRAF mutation positive, a BRAF inhibitor drug with or without a MEK inhibitor drug that has also stopped working.
The approval of Amtagvi is based on a study that measured response rate. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.
Iovance Biotherapeutics, Inc. aims to be a leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for cancer patients. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. The company is committed to continuous innovation in cell therapy, including gene-edited cell therapy.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries.
Source: Iovance Biotherapeutics, Inc.
