Expert Clinical Network Insights: June 2024

A look into our Expert Clinical Network (ECN) — part of Prime/MRx’s value-based approach to medical and pharmacy benefit management that offers access to more than 175 national and world-renowned key opinion leaders in multiple disease categories who provide expertise on challenging prior authorization case reviews, peer-to-peer discussions, drug policy development and formulary guidance

June 18, 2024


Metastatic Melanoma


Lifileucel (Amtagvi™) 

The U.S. Food and Drug Administration (FDA) approved lifileucel (Amtagvi™) in February 2024 through the accelerated approval pathway for the treatment of adult patients with unresectable or metastatic melanoma. Lifileucel is the first FDA-approved cellular therapy to treat patients with unresectable or metastatic melanoma.¹ Lifileucel is a tumor-derived autologous T-cell immunotherapy that is administered as a single dose for infusion in the inpatient hospital setting.¹ Prime Therapeutics and Magellan Rx Management (Prime and Magellan Rx) sought insight from key opinion leader(s) (KOL) within our Expert Clinical Network (ECN) who specialize in oncology. This month’s newsletter summarizes KOL feedback on a new cellular therapy for melanoma.

Efficacy and safety

Lifileucel is a first-in-class cellular therapy for solid tumor cancers that appears to be a promising treatment option for patients with unresectable or metastatic melanoma who are refractory to immune checkpoint inhibitors (ICI).

In clinical trials, nearly one-third of participants treated with lifileucel had a tumor response with at least some reduction in tumor size, with some achieving a complete response. Additionally, over 40% of patients whose disease was responsive to lifileucel had no progression 12 months after receiving their infusion. For many patients, lifileucel may be a treatment option for long-term clinical benefit after they have exhausted other FDA-approved treatments for melanoma, including ICI therapy and/or BRAF inhibitors, if applicable.

From a safety perspective, lifileucel appears to have a milder adverse effect profile when compared to patients treated with chimeric antigen receptor (CAR) T-cell therapy. Although lifileucel commonly results in fever, anemia, tachycardia, and decreased levels of platelets and white blood cells, it appears to have less serious immune-related adverse events, such as cytokine release syndrome and neurologic effects, that are commonly seen in patients receiving CAR T-cell therapy. As discussed below, within the overall treatment process, a patient’s ability to tolerate interleukin-2 (IL-2) therapy also needs to be considered from a safety perspective.

Manufacturing and patient access

From an access standpoint, there are several patient and manufacturing elements that need to be considered. Performance status, adequate respiratory and cardiac function, prior lines of therapy, and ability to tolerate IL-2 therapy are all important patient considerations. In terms of potential manufacturer barriers, the accessibility of tumor for acquisition, the ability to harvest T-cells, and the number of T-cells available can all potentially impact patient access.

Given the fact lifileucel is a tumor-derived T-cell immunotherapy, tumor resection is required. Unlike CAR T-cell therapies, where T cells are collected from the patient’s peripheral blood, tumor-infiltrating lymphocyte (TIL) therapies require collection of T cells directly from the patient’s tumor. As part of the production process, these TILs are then expanded in the presence of IL-2 in a laboratory setting before reinfusion. Prior to receiving lifileucel, patients should receive lymphodepleting chemotherapy. After lifileucel infusion, IL-2 should be administered. At this time, only certain specialty centers are involved in the tumor collection and treatment administration process.

Although the cellular therapy is not universally available to date, patient access will be an important consideration since lifileucel fills an unmet need in the treatment of melanoma.

Want more information on this topic and more from our KOLs?

Our Expert Clinical Network program features a variety of offerings, including complete newsletter insights, drug management considerations, prior authorization case reviews and policy inquires.

  1. FDA approves first cellular therapy to treat patients with unresectable or metastatic melanoma. Updated February 16, 2024. Available at: Accessed April 25, 2024.

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