Biotech & Health

Immunocore in Rockville Wins FDA Approval for Kimmtrak Melanoma Treatment

MBS Staff
Immunocore eyes device. Kimmtrak therapy treatment for unresectable or metastatic uveal melanoma won FDA approval.

Another Montgomery County Biotech has received FDA approval paving the way for revenue and profitability. Immunocore Holdings plc (Nasdaq: IMCR), with an office in Rockville, won FDA approval for Kimmtrak, a therapy to treat unresectable or metastatic uveal melanoma (mUM).

Melanoma is considered the most serious type of skin cancer, according to the Mayoclinc. Those most at risk have had high exposure to ultraviolet radiation from sunlight or tanning.

Immunocore said Kimmtrak is the first and only FDA approved therapy specifically intended to treat metastatic uveal melanoma. It was granted Breakthrough Therapy Designation by the FDA in February 2021.

Immunocore Holdings, Kimmtrak therapy to treat unresectable or metastatic uveal melanoma (mUM) cancer was approved by the FDA.

Image: Immunocore Holdings plc (Nasdaq: IMCR)

“Today’s approval of KIMMTRAK is a historic milestone and the culmination of years of dedication by the Immunocore team, patients, and our healthcare partners. Every year in the United States, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options. KIMMTRAK is the first therapy to demonstrate a survival benefit to patients with this disease and we are focused on making KIMMTRAK available as quickly as possible,” said Bahija Jallal, Chief Executive Officer of Immunocore.

“We’re also proud to have developed the world’s first approved TCR therapeutic, which we believe validates the strength of our platform and opens doors for us to explore further breakthrough discoveries in TCR therapeutics for the treatment of other cancers and diseases with high unmet need.”

According to the National Center for Biotechnology Information (part of the U.S. National Library of Medicine at the National Institutes of Health in Bethesda), unresectable uveal melanoma is a particular kind of melanoma that is not responsive to surgery where the infected portion is removed.

“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients,” said John Kirkwood, MD, director of the Melanoma Center at the UPMC Hillman Cancer Center. 

“The approval of KIMMTRAK (tebentafusp-tebn) represents a major paradigm shift in the treatment of metastatic uveal melanoma, and for the first time offers hope to those with this aggressive form of cancer.”

Immunocore’s Phase 3 (IMCgp100-202) clinical trial had a total of 378 patients testing Kimmtrak against competing treatments of either pembrolizumab, ipilimumab, or dacarbazine. It was the largest metastatic uveal melanoma clinical trial to date.

The OS Hazard Ratio (HR) also favored Kimmtrak over competing options at 95% versus 82% for pembrolizumab, 13% for ipilimumab, and 6% for dacarbazine.

“When my husband, Gregg, was diagnosed with metastatic uveal melanoma, it was devastating to learn that there were no treatment options shown to extend life,” said Sara Selig, MD, MPH, Co-Founder and Director of the Melanoma Research Foundation’s (MRF) CURE OM initiative. “Now, for the first time in the history of this disease, we will soon see extended survival in the next generation of metastatic uveal melanoma patients.”

Immunocore has already laid the groundwork for commercialization with distribution in the United States and is expected to happen within several weeks. 

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