MRA Celebrates Approval of Tebentafusp - First Drug for Metastatic Uveal Melanoma

By Cody Barnett, MPH, MRA Senior Director of Communications & Patient Engagement | 26 January 2022 | News, Treatment

New Uveal Melanoma Drug

The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, applauds the U.S. Food and Drug Administration (FDA) decision to approve the first-ever therapy for metastatic or unresectable uveal melanoma. 

Uveal melanoma, often called ocular melanoma, is a rare melanoma subtype that affects about 2,500 people each year in the United States. Uveal melanoma is often treated with radiation therapy, however about half of patients experience disease recurrence or metastasis within 3-5 years. Tebentafusp is the first drug to earn FDA approval to treat these patients.

“This approval represents a new day for patients and families affected by uveal melanoma,” says MRA Chief Science Officer Marc Hurlbert, PhD. “Previously, patients facing metastatic uveal melanoma – among other rare melanoma subtypes – had few effective treatment options. Today’s approval renews hope that patients facing these rare forms of melanoma aren’t being left behind.”

Tebentafusp, the first T cell receptor (TCR) therapeutic to be FDA approved, works by binding to both melanoma cells and T cells, bringing these two cell types into closer proximity to facilitate tumor killing. In addition to being studied in uveal melanoma, clinical trials are also evaluating its use in the treatment of autoimmune and infectious diseases.

Tebentafusp was approved based on results from Immunocore’s Phase 3 IMCgp100-202 clinical trial. In this randomized trial, 378 patients with previously untreated metastatic disease received tebentafusp or a standard of care therapy. Patients receiving tebentafusp demonstrated a 15% increase in overall survival at one year compared to those receiving a standard of care therapy (73% versus 58%). All tebentafusp-related adverse reactions were manageable and included rash (18%), fever (4%), and itching (5%). 

“The FDA’s approval of tebentafusp is a critical step in our ongoing fight against melanoma. However, we must continue to invest in rare melanoma research if we are to achieve MRA’s mission of ending suffering and death due to melanoma,” says MRA President & CEO Michael Kaplan.