US Exchange Filings

Iovance Biotherapeutics Reports Record Q3 Revenue, Advances Lifileucel Trials

Iovance posted record third-quarter revenue of about $122 million as Amtagvi sales surged and gross margins improved, while keeping its 2026 revenue target unchanged. New lifileucel results could also support the therapy’s expansion into lung cancer and other settings.

Iovance Biotherapeutics reported record third-quarter revenue of about $122 million, driven by continued growth in U.S. sales of Amtagvi, its TIL therapy for cancer. The company also reported higher gross margin and new clinical-trial results for lifileucel in lung cancer and sarcoma, while saying it remains on track to generate $410 million to $420 million in revenue in 2026.

The update combines commercial progress with plans to advance lifileucel into additional cancer settings. Iovance said more than 1,000 patients have now been treated commercially with Amtagvi.

Key details

  • Revenue rose sharply: Total product revenue was about $122 million, up roughly 80% from the third quarter of 2025 and 22% from the second quarter of 2026.
  • Amtagvi led sales: U.S. Amtagvi revenue was about $102 million, increasing approximately 77% year over year and 12% quarter over quarter. Global Proleukin revenue was about $20 million.
  • Gross margin improved: Gross margin reached about 60%, compared with 56% in the previous quarter. Iovance attributed the increase to higher Amtagvi sales volume and cost-optimization efforts across production.
  • Research and development spending declined: R&D expenses fell about 16% from the second quarter. The company said this was its fifth consecutive quarter of improvement, citing operational efficiencies while expanding its development work.
  • 2026 revenue target unchanged: Iovance said it remains on track to deliver full-year revenue of $410 million to $420 million.

Clinical and pipeline updates

  • Lung cancer results: In the IOV-LUN-202 trial, lifileucel produced an objective response rate of 24.6% among 69 patients with metastatic non-squamous non-small-cell lung cancer. Iovance said responses showed durability greater than current standard of care, though it did not provide further comparative detail in the release.
  • Biomarker-selected subgroup: The company reported a 59.1% response rate in a biomarker-selected group of patients. It is launching the POSITILITY and OPTILISM trials based on these results.
  • Potential regulatory submission: Iovance said enrollment in the first two IOV-LUN-202 cohorts is nearing completion and that it is preparing a supplemental application for lifileucel.
  • Sarcoma results: In nine patients with undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma, lifileucel had a confirmed response rate of 55.6%, with what the company described as strong durability. The results support the ongoing SARATOGA registrational trial.

What it means

Amtagvi accounted for most of the reported product revenue, and the quarter’s higher margin coincided with increased sales volume and production-cost initiatives. The lung-cancer and sarcoma results give Iovance additional clinical programs to advance, but the reported response rates come from relatively small patient groups—69 patients in the broader lung-cancer cohorts and nine in the sarcoma data.

Original Filing

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