Immunocore (IMCR) Announces FDA Approval of KIMMTRAK for the Treatment of Unresectable or Metastatic Uveal Melanoma


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Immunocore announces FDA approval of KIMM TRAK® (tebentafusp-tebn) for treatment of unresectable or metastatic uveal melanoma

KIMM TRAK is the first one and only FDA approved therapy for the treatment of inoperable or metastatic uveal melanoma (mom)

KIMMTRAK is the first T cell receptor (TCR) therapeutic receive regulatory approval

KIMMTRAK demonstrated statistically and clinically significant overall survival (SE) advantagehazard ratio of 0.51, with a median OS of nearly 22 months The company will host an investor call Today at 8:30 A M HEY

Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering the development of a new class of bispecific T-cell receptor (TCR) immunotherapies designed to treat a wide range of diseases, including cancer, autoimmune and infectious diseases, today announces U.S. Food and Drug Administration (FDA) approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of HLA-A*02:01 positive adult patients with unresectable or metastatic uveal melanoma (mom).

KIMMTRAK’s approval sets many firsts as the first TCR therapy to receive FDA regulatory approval, the first bispecific T-cell engager to receive FDA regulatory approval to treat a solid tumor, and the first and the only therapy for the treatment of unresectable or metastatic uveal melanoma must be FDA approved.

Bahija Jallal, CEO of Immunocore, said: “Today’s endorsement from KIMMTRAK is a historic milestone and the culmination of years of devotion by the Immunocore teamthe patients, and our healthcare partners. Each year in the United States, hundreds of people are diagnosed with metastatic uveal melanoma which, until now, had no approved treatment options. KIMMTRAK is the first therapy to to prove a survival advantage for patients with this disease and we are concentrated on the manufacture of KIMMTRAK available as soon as possible.

Dr. Jallal continues: “We are also proud to have developed the world’s first approved TCR therapeutic treatment, which we believe validates the strength of our platform and opens doors for us at to explore any further breakthrough discoveries in TCR therapy for the treatment of other cancers and diseases with high unmet need.

“Uveal melanoma is a devastating disease that has consistently resulted in death within a year of our patients metastasizing,” said John Kirkwood, MD, director of the Melanoma Center at UPMC Hillman Cancer Center. “KIMMTRAK’s endorsement (tebentafusp-tebn) represents a major paradigm shift in the treatment of metastatic uveal melanoma, and for the first time offers hope for people with this aggressive form of cancer.

KIMMTRAK’s approval is based on results from Immunocore’s IMCgp100-202 Phase 3 clinical trial, which were published in the September 23, 2021 issue of New England Journal of Medicine. The pivotal randomized trial evaluated the overall survival (OS) of KIMMTRAK versus investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in patients with previously untreated mUM. 378 patients were randomized 2:1 to receive either KIMMTRAK or Investigator’s Choice. Data from the trial, the largest Phase 3 trial undertaken in mUM, showed that KIMMTRAK demonstrated unprecedented median OS benefit as a first-line treatment. The relative risk of OS (HR) in the intent-to-treat population favored KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p

“When my husband, Gregg, was diagnosed with metastatic uveal melanoma, it was devastating to learn that there were no life-prolonging treatment options.” noted Sara Selig, MD, MPH, co-founder and director of MElanoma Research Foundation’s (MRF) CURE OM Initiative. “Now, for the first time in the history of this disease, we’ll see soon prolonged survival in the next generation of metastatic uveal melanoma the patients.”

In the phase 3 randomized trial of KIMMTRAK (tebentafusp-tebn), treatment-related adverse events were manageable and consistent with the proposed mechanism. Among patients treated with KIMMTRAK, the most common Grade 3 or higher adverse reactions were rash (18%), pyrexia (4%) and pruritus (5%). In the 245 patients treated with KIMMTRAK, grade 3 cytokine release syndrome (CRS) occurred in

“Until now, effective treatment options for patients with metastatic uveal melanoma have been virtually non-existent. The approval of KIMMTRAK not only represents a new therapy, but a a new hope for the individuals and families of those diagnosed with the deadliest form of eye cancer,” noted Kyleigh LiPiraMBA, CEO of LIM.

The company is ready to market KIMMTRAK and expects to have the product available in the United States within weeks.

KIMMTRAK received Breakthrough Therapy designation for unresectable or metastatic uveal melanoma from the FDA in February 2021. Biologics License Application (BLA) approval followed review under the Real-Time Oncology Review program (RTOR), an initiative of the FDA Oncology Center of Excellence designed for the efficient delivery of safe and effective cancer treatments to patients. Approval was granted four weeks prior to the assigned PDUFA date of February 23, 2022. Immunocore provided ASSESSMENT ASSISTANCE to facilitate FDA review. KIMMTRAK is being reviewed under the FDA’s Project Orbis initiative, which allowed for concurrent review by health authorities in partner countries that requested their participation.

The European Medicines Agency (EMA), the UK Medicines and Healthcare Regulatory Agency (MHRA), Health Canada and the Australian Department of Health’s Therapeutic Goods Administration (TGA) have agreed submission of the company’s marketing authorization application. Additionally, Immunocore has launched a global early access program to make KIMMTRAK readily available to mUM patients. There are currently over 200 patients in 13 countries in the early access program.

Immunocore is committed to helping patients who need KIMMTRAK access it through its KIMMTRAKConnect program. The program offers services with dedicated nurse case managers who provide personalized support, including educational resources, financial assistance, and care site coordination. To learn more, visit KIMMTRAKConnect.comwhich will launch later this week, or call 844-775-CARE (2273).

Conference call information

Immunocore will host a conference call and webcast today, Wednesday, January 26 at 8:30 a.m. EST. A live webcast of the conference call will be available under “Events” in the Investor Relations section of Immunocore Holdings’ website at www.immunocore.com. To access the live conference call by phone, please dial (US) 877-405-1224 / (Non-US) +1-201-389-0848. The presentation from today’s call and the archived webcast will be available on Immunocore’s website after the conference call ends and will be available for 60 days after the call.

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