Iovance Biotherapeutics Inc. (IOVA) on Tuesday reported encouraging early results from a pilot study evaluating its tumor-infiltrating lymphocyte therapy, lifileucel, in patients with aggressive soft tissue sarcomas who had exhausted prior treatments.
The company said the findings support plans to pursue a potential speedy approval pathway in the United States.
The data comes from a clinical trial led by Memorial Sloan Kettering Cancer Center and backed by Iovance, testing lifileucel in patients with advanced undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) whose disease had progressed after at least one systemic therapy.
Among the first six patients whose outcomes could be evaluated, half experienced a confirmed tumor response. Investigators noted that tumor shrinkage deepened over time, mirroring patterns previously observed with lifileucel in melanoma and other solid tumors.
The company also reported strong fourth-quarter (Q4) earnings led by $65 million in Amtagvi revenue. Following the update, Iovance stock traded over 5% higher in Tuesday’s premarket. On Stocktwits, retail sentiment around the stock shifted to ‘extremely bullish’ from ‘bullish’ territory the previous day amid ‘high’ message volume levels.
Based on the initial findings, Iovance said it intends to launch a single-arm registrational trial in the second quarter of 2026 for second-line advanced UPS and DDLPS. The company plans to consult with the U.S. Food and Drug Administration regarding a potential expedited review process.
“In the first clinical trial of a TIL cell therapy in UPS and DDLPS, one-time treatment with lifileucel demonstrated compelling and unprecedented response rates with the potential to address a significant unmet need in patients who are refractory to frontline standard of care.”
-Lauren Baker Banks, Sarcoma Medical Oncologist, Memorial Sloan Kettering Cancer Center
In Q4, total product revenue was about $87 million, marking roughly 30% growth year-over-year. Gross margin for the quarter was approximately 50%, driven by improved operations and ongoing cost control efforts.
IOVA stock has declined by over 47% in the last 12 months.
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