On February 24, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported fourth quarter and full year 2025 financial results, business achievements and corporate updates.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Iovance delivered approximately 30 percent quarterly revenue growth and achieved our 2025 guidance range in the first full calendar year of launch. Growth was driven by increasing demand for Amtagvi. After ongoing improvements in our operations and gross margin, we are well positioned for future profitability. Iovance is poised to create substantial value for patients and shareholders as we increase revenue while advancing our registrational trial in non-small cell lung cancer and best-in-class TIL pipeline in solid tumors."
Fourth Quarter and Full Year 2025 Financial Highlights
Topline Growth, Significant Margin Improvement, and Cost Optimization
Fourth quarter 2025 total product revenue of ~$87 million with strong growth of ~30% over the prior quarter, including:
U.S. Amtagvi revenue of ~$65 million.
Global Proleukin revenue of ~$22 million.
Fourth quarter 2025 gross margin from cost of sales was ~50%, reflecting increasing benefits from solid execution and cost optimization.
Full year 2025 total product revenue of ~$264 million achieved the guidance range of $250 million to $300 million in the first full year of launch, including:
U.S. Amtagvi revenue of ~$220 million.
Global Proleukin revenue of ~$44 million.
The cash position as of December 31, 2025 of ~$303 million1 is expected to fund operations into the third quarter of 2027.
Operational excellence initiatives, including internalization of all lifileucel manufacturing and optimization of research and development activities, are expected to drive significant additional improvements in operating expenses, cost of sales and gross margin in 2026 and 2027.
Amtagvi Commercial Launch
Strong U.S. Commercial Growth and Execution with Approvals Pending in New Global Markets
Best-in-class Amtagvi real-world response rates are increasing adoption and strengthening referral trends toward earlier treatment.
An oral presentation 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) reported:
An unprecedented overall objective response rate (ORR) of ~44%.
Higher ORR of 52% after two or fewer prior lines of therapy, highlighting the importance of early treatment.
A continuously growing and maturing network of U.S. authorized treatment centers (ATCs) expanded patient access in 2025, with further acceleration anticipated in 2026.
Academic ATCs are contributing to growth as new centers onboard and experienced centers treat more patients.
The first community ATCs began treating patients in late 2025 and are expected to drive additional demand in 2026.
A specialty pharmacy distribution channel was introduced as another option for ATCs to purchase Amtagvi.
Five-year analysis of the C-144-01 trial of Amtagvi demonstrated ~31% ORR, median duration of response (mDOR) of 36+ months, and ~20% five-year overall survival, highlighting the unprecedented long-term benefits of this first-in-class therapy.
Manufacturing turnaround improved to 32 days or less from inbound to return shipment to ATCs.
Global expansion of Amtagvi is underway in several markets outside the U.S.
Amtagvi was approved in Canada in August 2025.
Regulatory submissions are under review with potential approvals in the United Kingdom and Australia in the first half of 2026, and Switzerland in the first half of 2027.
Iovance is working with the European Medicines Agency (EMA) to resubmit a marketing authorization application (MAA) in 2026.
Lifileucel in Previously Treated Advanced NSCLC: IOV-LUN-202 Registrational Trial
Clinical and Regulatory Momentum Building Towards Potential 2H27 Launch
The U.S. FDA granted Fast Track Designation (FTD) for lifileucel for the treatment of adults with metastatic nonsquamous (NSQ) NSCLC that has progressed on or after chemo- and anti-PD-1 therapies and at least one line of FDA-approved targeted therapy, if indicated, for actionable tumor mutations excluding ALK, ROS1 and EGFR.
Positive interim data demonstrated a potential best-in-class profile in NSQ advanced NSCLC patients.
The ORR was 26% and mDOR was not reached at 25+ months of follow up following one-time lifileucel monotherapy.
Standard of care docetaxel has shown 12.8% ORR, 5.6 months mDOR, and 12.3 months overall survival, highlighting a significant unmet medical need.2
Anticipated milestones:
Present updated data at a major medical meeting in 2026.
Complete enrollment in 2026.
Support a supplemental Biologics License Application for U.S. accelerated approval with a potential launch in the second half of 2027.
Pipeline Updates
New Data Across Several Pipeline Programs Anticipated Throughout 2026
Iovance announced positive early data for one-time lifileucel treatment in patients with advanced undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy:
Among the first six evaluable patients, the confirmed RECIST v1.1 ORR was 50%.
Iovance plans to commence a single arm registrational trial in previously treated advanced UPS and DDLPS in the second quarter of 2026 and engage with the FDA on a path to expedited approval.
The Phase 3 TILVANCE-301 trial of lifileucel and pembrolizumab in frontline advanced melanoma made significant progress, with enrollment accelerating across a broad and expanding global footprint. The U.S. FDA previously granted FTD in frontline advanced melanoma for lifileucel in combination with pembrolizumab. The TILVANCE-301 trial is designed with FDA and EMA input to show contribution of components for lifileucel in combination with pembrolizumab compared to pembrolizumab alone.
Two of Iovance’s Phase 2 trials, IOV-END-201 and IOV-MEL-202, are investigating lifileucel in previously treated patients with advanced endometrial cancer and melanoma, respectively.
A Phase 1/2 trial is investigating IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and NSCLC.
A Phase 1/2 trial is investigating IOV-3001, a second-generation, modified IL-2 analog for use in the TIL treatment regimen.
An Investigational New Drug (IND) submission is planned in the first half of 2026 to begin clinical development of IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL therapy, in a Phase 1/2 basket trial.
Multiple investigator-sponsored clinical trials are exploring new solid tumor indications for Iovance TIL therapies and next generation approaches.
Webcast and Conference Call
Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register at View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year.
(Press release, Iovance Biotherapeutics, FEB 24, 2026, View Source [SID1234662918])