Iovance posts record Q2 2026 revenue, gains FDA fast track for lifileucel in sarcomas

Iovance Biotherapeutics reported second quarter 2026 results on August 6, 2026, with total product revenue of about $99 million, up 66% from about $60 million in the second quarter of 2025, and U.S. Amtagvi revenue of about $91 million, up 40% from the fourth quarter of 2025.¹ Given this performance, Iovance is reviewing its full-year 2026 revenue guidance of $350 million to $370 million, with an update expected during the third quarter.¹

On the regulatory side, the FDA granted Fast Track Designation for the SARATOGA registrational trial in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, based on early data showing an objective response rate of 50% in the first six evaluable patients.¹ Results will be presented at ESMO in Madrid from October 23-27, 2026, per the release.

In lung cancer, initial results from the IOV-LUN-202 trial in previously treated metastatic non-squamous NSCLC supported FDA Fast Track Designation, with enrollment nearly complete in pivotal cohorts, program updates expected in the fourth quarter of 2026, and a supplemental Biologics License Application submission planned for 2027.¹

The TILVANCE-301 Phase 3 trial combining lifileucel and pembrolizumab in frontline advanced melanoma continues enrolling, and includes an early interim analysis based on objective response rate for a potential supplemental BLA, and also serves as the confirmatory study for lifileucel's accelerated approval in second-line advanced melanoma.¹

Internationally, Amtagvi's marketing authorization application in Australia was approved by the Therapeutic Goods Administration, marking the third global approval,¹ while the UK application was resubmitted in early July and is under expedited review by the MHRA for potential approval later in 2026.¹

On cash, as of June 30, 2026, Iovance's cash position was approximately $304 million, expected to fund operations into the second half of 2028.¹