Iovance Biotherapeutics reported robust second quarter 2025 financial results, with total product revenue reaching $60.0 million, marking a 93% increase compared to $31.1 million in the second quarter of 2024. The strong performance was driven primarily by accelerating adoption of Amtagvi (lifileucel), the first FDA-approved T cell therapy for solid tumors, in treating advanced melanoma patients.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "In the first half of 2025, we continued to drive U.S. adoption for Amtagvi in advanced melanoma, surpassing more than 100 patients treated within a single quarter. Growth for Amtagvi and Proleukin will continue in the second half of 2025 as existing ATC growth continues and large community practices begin treating patients."
Commercial Performance Demonstrates Strong Market Uptake
Amtagvi generated $54.1 million in product revenue during Q2 2025, representing treatment of 102 commercial patients. This growth reflects increased field activities in existing Authorized Treatment Centers (ATCs) and contributions from newly onboarded treatment facilities. The Amtagvi treatment network now includes more than 80 U.S. ATCs across 35 states, with 95% of addressable patients living within 200 miles of an ATC.
Real-world data from commercial Amtagvi use showed promising efficacy results. The physician-assessed objective response rate (ORR) was 48.8% among 41 evaluable patients treated with commercial Amtagvi. Notably, the response rate was higher in patients receiving earlier treatment, with 60.9% ORR in third-line or earlier patients compared to 33.3% in patients following three or more prior lines of therapy.
Proleukin revenue contributed $5.9 million to the quarter's results, reflecting restocking orders from two major U.S. wholesalers to keep pace with increasing Amtagvi utilization. Strong growth in Proleukin revenue is expected in the second half of 2025, aligning with Amtagvi demand and year-end restocking patterns at U.S. distributors.
Manufacturing and Operational Excellence
The company has achieved significant improvements in manufacturing efficiency, with turnaround time improving to 33 days from inbound to return shipment to ATCs. The overall commercial manufacturing experience remains consistent with prior clinical experience, supporting scalable production of the personalized TIL therapy.
To enhance market access, Iovance entered into a specialty pharmacy agreement with Biologics by McKesson, a key offering within InspiroGene, McKesson's suite of CGT commercialization solutions. This new access channel, added in direct response to requests from large community practices, provides an additional option for providers to acquire Amtagvi alongside the traditional direct purchase channel.
Global Expansion Strategy Advances
Iovance is preparing for international market expansion, with Health Canada expected to approve Amtagvi monotherapy in the coming weeks as the first T cell therapy for a solid tumor cancer and first treatment option in Canada for previously treated advanced melanoma. The company is preparing for a commercial launch in Canada over the next few months.
However, the company recently withdrew its marketing authorization application (MAA) from the European Medicines Agency (EMA) following interactions with EMA's Committee for Medicinal Products for Human Use. A new strategy is in development to make Amtagvi and TIL therapy broadly accessible to patients in the EU.
Additional regulatory progress includes review in the United Kingdom on track for potential approval and launch in the first half of 2026, Australia's Therapeutic Goods Administration granting Priority Review with a decision anticipated in early 2026, and Swiss Medic recommending Priority Review ahead of the Swiss regulatory submission planned in Q4 2025.
Pipeline Development Continues
The company's clinical pipeline remains robust with multiple programs advancing. The registrational TILVANCE-301 trial continues with strong momentum to support U.S. approval of Amtagvi in combination with pembrolizumab in frontline advanced melanoma. The trial was designed with FDA and EMA input to show the contribution of components for Amtagvi in combination with pembrolizumab compared to pembrolizumab alone.
For non-small cell lung cancer (NSCLC), Iovance remains on track to share additional data in the second half of 2025 from the IOV-LUN-202 registrational Phase 2 trial to support a potential U.S. accelerated approval of lifileucel monotherapy in post-anti-PD-1 NSCLC in 2027. The FDA previously provided positive regulatory feedback on the IOV-LUN-202 clinical trial design and proposed potency assay matrix to support registration.
Long-term Clinical Data Validates Platform
The Journal of Clinical Oncology published the final five-year analysis from the Phase 2 C-144-01 clinical trial evaluating one-time lifileucel monotherapy, demonstrating unprecedented durability in previously treated advanced melanoma patients. The ORR was 31.4% and nearly one third of responders (31.3%) had ongoing responses. Median duration of response was 36.5 months, median overall survival was 13.9 months and five-year overall survival was 19.7%.
Strategic Restructuring Extends Runway
Iovance implemented a strategic restructuring to optimize business performance, resulting in more than $100 million in annual cost savings starting in Q4 2025 and extending cash runway into Q4 2026. The restructuring includes a workforce reduction of approximately 19% in Q3 2025, while maintaining all registrational and early-phase programs on track.
As of June 30, 2025, Iovance had cash, cash equivalents, investments, and restricted cash of approximately $307.1 million. The current cash position and anticipated product revenue, including cost savings from the strategic restructuring, are expected to be sufficient to fund current and planned operations into Q4 2026.
Financial Guidance Maintained
Iovance reiterated total product revenue guidance within the range of $250 to $300 million for the full year 2025, representing the first full calendar year of Amtagvi sales. The forecast continues to track in line with current and expected ATC growth trajectories, including large community practices and community referral activities. The company expects continued growth in total product revenue for the full year 2026 and beyond, with gross margins expected to increase through near-term optimization of manufacturing capacity utilization.
