Iovance Q4 Revenue Jumps 30% to $87M; Lifileucel Shows 50% ORR
Iovance reported Q4 revenue of $87M, up 30% sequentially, and full-year 2025 revenue of $264M, meeting guidance, with gross margin rising to 50% and cash of $303M to fund operations into Q3 2027. Lifileucel demonstrated a 50% ORR in advanced UPS and DDLPS, triggering a registrational trial in 2Q26.
1. Q4 and Full Year 2025 Financial Performance
Iovance reported Q4 2025 product revenue of ~$87 million, up ~30% sequentially, led by $65 million from Amtagvi in the U.S. and $22 million from Proleukin globally. Full-year revenue reached ~$264 million, matching the $250–300 million guidance range, while gross margin improved to ~50% and cash of ~$303 million provides runway into Q3 2027.
2. Lifileucel Pilot Trial in Undifferentiated Pleomorphic Sarcoma and DDLPS
In a pilot study of advanced undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS), one-time lifileucel monotherapy yielded a 50% objective response rate among six evaluable patients, with durable deep responses and a favorable safety profile. These data underpin a single-arm registrational trial slated to launch in the second quarter of 2026 and engagement with regulators on an accelerated approval path.
3. Pipeline and Expansion Plans
Iovance is advancing global expansion of Amtagvi with approval secured in Canada and regulatory submissions under review in the U.K., Australia (1H 2026) and Switzerland (1H 2027). Additionally, the FDA granted Fast Track designation for lifileucel in second-line advanced non-small cell lung cancer, with updated data presentations and trial enrollment expected through 2026 ahead of a potential late-2027 launch.