Amtagvi shows 61% response rate in less heavily treated melanoma patients

SAN CARLOS, Calif. - Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a clinical-stage biotechnology company with a current market capitalization of $624 million, announced Monday that a real-world retrospective study of its commercial tumor infiltrating lymphocyte (TIL) therapy Amtagvi demonstrated a 48.8% objective response rate in advanced melanoma patients previously treated with immune checkpoint inhibitors. While the stock has seen a notable 10% gain over the past week, InvestingPro analysis indicates the shares remain undervalued at current levels.

The study evaluated 41 patients treated at four authorized treatment centers who had received Amtagvi according to U.S. prescribing information. Response rates were notably higher in patients who had received fewer prior treatments, with a 60.9% response rate observed in third-line or earlier patients compared to 33.3% in those who had undergone three or more prior lines of therapy.

"Lifileucel demonstrates a robust response rate in real-world clinical settings," said Dr. Lilit Karapetyan of H. Lee Moffitt Cancer Center & Research Institute, according to the company’s press release.

Amtagvi received accelerated approval from the FDA in February 2024 for treating adult patients with unresectable or metastatic melanoma previously treated with PD-1 blocking antibody and, if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

The therapy represents the first one-time T cell therapy approved for a solid tumor cancer and the first approved treatment option for advanced melanoma patients after anti-PD-1 and targeted therapy.

Iovance is currently conducting TILVANCE-301, a Phase 3 trial in frontline advanced melanoma to confirm clinical benefit. Additional results from the real-world study will be presented at an upcoming medical meeting this year, according to the company statement.

In other recent news, Iovance Biotherapeutics reported several significant developments. The company announced the resignation of Chief Financial Officer Jean-Marc Bellemin, effective July 10, 2025, as he plans to pursue new opportunities. Matthew Rosinack has been appointed as the interim Principal Financial Officer and Principal Accounting Officer. Additionally, Iovance shareholders approved key proposals during a virtual annual meeting, including the election of board members and amendments to incentive plans, reflecting strong shareholder engagement.

Goldman Sachs has reiterated its Buy rating for Iovance, citing promising 5-year survival data for Amtagvi in advanced melanoma, with a price target set at $8.00. Analysts highlighted the importance of early patient identification and increased awareness of the treatment. H.C. Wainwright also maintained a Buy rating, with a $20.00 price target, emphasizing the significance of recent clinical trials and data presentations. The firm noted the potential of tumor-infiltrating lymphocyte therapy in solid tumors, including non-small cell lung cancer, as a catalyst for future growth.

Despite recent challenges, both analyst firms expressed optimism regarding Iovance’s strategic direction and potential for improvements in operations. These developments are based on recent statements and presentations by the company and analyst firms.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.