Real-World Data with Amtagvi Show High Response Rates in Advanced Melanoma

Iovance Biotherapeutics announced data demonstrating that patients with advanced melanoma experienced high response rates when treated with commercial Amtagvi (lifileucel) in a real-world clinical study.

This retrospective analysis evaluated the effectiveness of the first one-time T-cell therapy for a solid tumor in 41 evaluable patients whose cancer was unresectable or metastatic and had previously been treated with anti-PD-1 and targeted therapies. The findings suggest that this tumor-infiltrating lymphocyte (TIL) therapy may offer a best-in-class profile for those who have progressed after receiving standard immune checkpoint inhibitors.

Main data that support the findings

The retrospective study revealed a physician-assessed confirmed objective response rate (ORR) of 44%, with 18 out of 41 patients achieving a response. Additionally, the disease control rate was 73%, representing 30 out of 41 patients. These real-world results improved upon the 31% ORR observed in the C-144-01 clinical trial, which originally supported the U.S. Food and Drug Administration (FDA) accelerated approval of the therapy.

Data indicated that patients who received Amtagvi earlier in their treatment journey experienced higher response rates. Specifically:

• Two or fewer lines of therapy: The ORR was 52% (12 of 23 patients).
• Three or more lines of therapy: The ORR was 33% (six of 18 patients).

Dr. Lilit Karapetyan of H. Lee Moffitt Cancer Center & Research Institute, stated that the 44% overall response rate supports the consideration of the treatment as soon as possible after immune checkpoint inhibitor use. Daniel Kirby, Chief Commercial Officer of Iovance, noted that these response rates, paired with five-year durability and survival data from previous analysis, demonstrate better outcomes in patients treated earlier.

Trial details

The data were highlighted in an oral presentation and involved patients treated at four authorized treatment centers according to U.S. prescribing information. Advanced melanoma represents a significant unmet medical need with more than 8,000 annual U.S. deaths, and more than half of patients treated with first-line standard of care progress within 12 months.

Amtagvi is a personalized prescription medicine made from a patient’s own surgically removed tumor. The manufacturing process involves:

• Cell Growth: Tumor-derived T cells are grown in a manufacturing center until they number in the billions.
• Timeline: It takes approximately 34 days from the time the manufacturing center receives the tissue until the product is ready for shipping.
• Preparation: Patients receive lymphodepleting chemotherapy to prepare the body for the infusion.
• Infusion: The treatment is delivered via intravenous infusion, typically taking less than 90 minutes.

Following the infusion, patients receive up to six doses of IL-2 (aldesleukin) every eight to 12 hours to support the T cells. Iovance is currently conducting the phase 3 TILVANCE-301 clinical trial in frontline advanced melanoma to confirm these clinical benefits.

Safety

Patients will likely be in a hospital before and after receiving Amtagvi and must stay until they have completed IL-2 treatment and recovered from any serious side effects. For several weeks after treatment, patients should plan to stay within two hours of the treatment location.

The most common side effects associated with Amtagvi include:

• Chills and fever
• Fatigue
• Low white blood cell count (which may increase infection risk)
• Low red blood cell count (which may cause tiredness or weakness)
• Fast or irregular heartbeat
• Low blood pressure
• Rash and diarrhea

Before taking Amtagvi, patients should tell their healthcare provider if they have lung, heart, liver or kidney problems; have low blood pressure; have active infections like CMV, hepatitis B or C or HIV; or are taking blood thinners. Patients should also disclose if they are pregnant, breastfeeding or have had a vaccination in the past 28 days. Doctors may discontinue IL-2 infusions at any time if a patient develops severe side effects.

Reference

1. “Best-in-Class Real-World Data Support Early Amtagvi® Treatment in Advanced Melanoma,” by Iovance Biotherapeutics. News release; Feb. 6, 2026.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI and reviewed by a human editor.

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