LN-145 - (IOV-LUN-202)

Aug. 6, 2026: Iovance Biotherapeutics (NASDAQ: IOVA) reported Q2 2026 results and pipeline/regulatory updates for lifileucel/Amtagvi. U.S. Amtagvi revenue reached about $91 million and total product revenue was about $99.3 million, up 66% year over year, with 56% gross margin; the company is reviewing its FY2026 revenue guidance of $350 million-$370 million and plans an update in 3Q26.

Regulatory/commercial: the TGA approved the marketing authorization application for Amtagvi in Australia. In the UK, the Amtagvi MAA was resubmitted in early July and is under expedited MHRA review for potential approval later in 2026. A Switzerland MAA decision is expected in 1H27, and an EMA resubmission for advanced melanoma is on track for 2027.

Pipeline: FDA granted Fast Track designation to lifileucel in soft tissue sarcomas (UPS/DDLPS); the registrational SARATOGA trial is underway, with early data showing 50% ORR by RECIST v1.1 in the first six evaluable patients. SARATOGA data and TILVANCE-301 frontline melanoma data were accepted for oral presentation at ESMO, Oct. 23-27, 2026. In metastatic non-squamous NSCLC (IOV-LUN-202), enrollment is nearly complete, updates are expected in 4Q26, and an sBLA is planned in 2027. Positive initial data were also reported in metastatic serous endometrial cancer, with a protocol amendment being submitted and FDA discussions ongoing on an expedited approval pathway.