Iovance Maps TIL Therapy Expansion After Record Revenue and Margin Gains

Iovance Biotherapeutics (IOVA) said it is expanding its tumor-infiltrating lymphocyte, or TIL, therapy platform across multiple solid-tumor indications after reporting a record second quarter marked by nearly $100 million in revenue and a 56% margin. Speaking at the H.C. Wainwright 28th Annual Global Investment Conference, Brian Gastman, Iovance’s executive vice president of translational medicine and research, said the company has moved TIL therapy from academic research into commercial use. He said Iovance has treated more than 2,000 patients clinically and commercially and has two approved and commercialized therapies: Amtagvi, its flagship TIL therapy, and Proleukin, also known as interleukin-2. Gastman said the company’s cash runway exceeds $300 million and extends into mid-2028, providing what he described as a “clear line of sight to profitability.” TIL therapy is a one-time, patient-specific treatment made from immune cells collected from a patient’s tumor. The cells are expanded into the billions and then returned to the same patient after preparatory treatment, Gastman said. Iovance manufactures the therapy at its Iovance Cell Therapy Center in Philadelphia. The facility supports clinical and commercial supply and has modular capacity for more than 5,000 patients, according to Gastman. He said the facility is a strategic asset for controlling supply, expanding margins and creating operating leverage as treatment volumes increase. The company has more than 95 authorized treatment centers, including roughly one-third in community settings, and expects to reach 110 centers by year-end. Gastman said more than 95% of U.S. patients are within 200 miles of a treatment center, while more than 80% are within 100 miles. He also said Iovance has payer policies covering more than 250 million lives, including Medicare and commercial coverage, representing more than 75% of the U.S. population. Gastman said the data supporting Amtagvi’s FDA approval, as well as approvals in Canada and Australia, showed durable responses in heavily pretreated melanoma patients. In an analysis of four experienced treatment centers, Iovance reported a 44% response rate, with response rates above 50% among patients treated in the second-line setting, he said. The company is also studying TIL therapy earlier in advanced melanoma. In the IOV-COM-202 Cohort 1A trial, Amtagvi combined with pembrolizumab in immune checkpoint inhibitor-naïve patients produced response rates in the mid-60% range and a 30% complete-response rate at the time of analysis, according to Gastman. Gastman said more mature data from the study are scheduled for an oral presentation at the European Society for Medical Oncology meeting. The regimen is also the experimental arm in Iovance’s internatio...