NEW YORK – Iovance Biotherapeutics said Thursday that since the US regulatory approval of Amtagvi (lifileucel) earlier this year, the first-in-class tumor-infiltrating lymphocyte (TIL) therapy has generated sales for the company for the first time.
Amtagvi garnered US Food and Drug Administration approval for advanced melanoma patients in February, making it the first autologous cell therapy to enter the market for a solid tumor indication. Now, for the three-month period ending June 30, Iovance said the treatment has brought in $12.8 million. The list price for Amtagvi is $515,000 per patient infusion.
Iovance updated shareholders about Amtagvi's launch during a call to discuss second quarter financial results on Thursday. According to the San Carlos, California-based firm, more than 90 percent of patients potentially eligible for Amtagvi live within 200 miles of one of Iovance's 50 authorized treatment centers (ATCs). Iovance said that onboarding is complete at these centers, which are located in 29 US states. By the end of 2024, Iovance is expecting to complete onboarding at more than 70 authorized treatment centers.
"We were very pleased with the exceptional demand for Amtagvi," Iovance interim CEO Fred Vogt said on the conference call. "The initial quarter of product revenue from our US launch demonstrates early success from our team's execution as well as the unmet need, high awareness, broad patient access, and motivated authorized treatment centers."
Iovance also said that its 34-day anticipated turnaround time for manufacturing Amtagvi has been on target with the firm's initial launch expectations. The manufacturing process involves harvesting and shipping patients' tumor samples to a manufacturing facility, harvesting patient-specific TILs from those samples, expanding them ex vivo, and then shipping them back to the patients' authorized treatment center for a one-time infusion. According to the drugmaker, efforts are underway to reduce this turnaround time.
According to Iovance, payors so far have been open to reimbursing the TIL therapy despite its steep list price, and it takes three weeks on average to receive prior authorization. About three-quarters of patients receiving Amtagvi have commercial insurance, and payors covering more than 225 million lives have added the cell therapy to their formularies since its launch. Iovance also said that the National Comprehensive Cancer Network (NCCN) includes Amtagvi in its guidelines as a preferred second- or later-line therapy for cutaneous melanoma.
"Amtagvi's inclusion in the [NCCN] guidelines reinforce clinical data and support broad payor coverage," Jim Ziegler, Iovance executive VP of commercial, said during the call. "There is strong demand at our ATCs, payor coverage policies are in place and favorable, and time to treatment is becoming faster."
Iovance is actively seeking approval for Amtagvi in advanced melanoma outside the US, too. In June, the firm submitted an application to the European Medicines Agency, and will file applications in the UK and Canada during the second half of this year. In the first half of 2025, Iovance plans to file for approval in Australia, followed by Switzerland and additional countries in the second half of 2025 and early 2026.
In the second quarter of this year, Iovance recorded total product revenue of $31.1 million, including $12.8 million for Amtagvi and $18.3 million for Proleukin (aldesleukin), which is used in the Amtagvi regimen. The company said it is expecting rapid uptake of these products in the coming months and years, and projected product revenue in the range of $53 million and $55 million in Q3 2024; $160 million and $165 million for fiscal year 2024; and $450 million and $475 million in fiscal year 2025.