Iovance Biotherapeutics saw its stock jump 32% on Tuesday after releasing early clinical data indicating a notable objective response to lifileucel in a small pilot study of patients with advanced undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS).
In the trial conducted by Memorial Sloan Kettering Cancer Center, lifileucel monotherapy produced an objective response rate of 50% among the first six evaluable patients. All six patients had advanced disease and were refractory to prior therapies. The company described the findings as sufficiently encouraging to move forward with plans to initiate a single-arm registrational study in second-line advanced UPS and DDLPS in the second quarter of 2026.
UPS and DDLPS are described by the company as high-grade, aggressive forms of soft tissue sarcoma. Iovance noted the patient populations affected number more than 3,000 individuals annually in the United States and more than 5,000 annually in Europe. The company highlighted a sizable unmet medical need in these indications, citing recent clinical studies that reported objective response rates below 5% in the second-line setting.
Alongside the clinical update, Iovance reported fourth-quarter product revenue of $86.71 million, ahead of the consensus estimate of $82.03 million. The company recorded a loss per share of $0.18, slightly wider than the analyst estimate of $0.17. Quarter-over-quarter, fourth-quarter revenue grew by approximately 30%, which Iovance attributed to U.S. Amtagvi sales of roughly $65 million and global Proleukin sales of roughly $22 million.
For full-year 2025, total product revenue reached approximately $264 million, placing the company within its provided guidance range of $250 million to $300 million in what the company characterized as the first full year since launch. Iovance reported a fourth-quarter gross margin from cost of sales of about 50%, which the company said reflected benefits from operational execution and cost-optimization efforts.
On the balance-sheet front, Iovance reported cash and cash equivalents of approximately $303 million as of December 31, 2025, and stated that this cash position is expected to fund operations into the third quarter of 2027. Separately, the U.S. Food and Drug Administration granted Fast Track Designation to lifileucel for the treatment of adults with metastatic nonsquamous non-small cell lung cancer.
The company’s clinical signal in UPS and DDLPS, combined with a revenue beat and a multi-quarter cash runway, appears to have driven the sharp share-price move following the announcements. While the pilot results are preliminary, they serve as the basis for a registrational study planned for the second quarter of 2026.