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Cell Therapy Takes on Solid Tumors: World's First Bispecific TCR-T Therapy Receives FDA Approval

Author: Candy Swift
by Candy Swift
Posted: May 08, 2022

On January 26, 2022, the U.S. Food and Drug Administration (FDA) approved the marketing of Kimmtrak (Tebentafusp-tebn), an innovative therapy from a British biotechnology company, for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

Notably, this is the first FDA-approved therapy for unresectable or metastatic mUM and the first FDA-approved T cell receptor (TCR) therapy, and the launch of Kimmtrak kicks off a global movement of T cell therapies into the realm of solid tumors.

TCR-T therapy entails obtaining T cells from patients and equipping the T cells with new T cell receptors that enable them to target specific cancer antigens in a therapy. This novel therapy allows physicians to engineer the most appropriate target for each patient's tumor and different types of T cells, individualizing treatment and offering patients a greater chance of remission.

Uveal melanoma is a rare and aggressive form of melanoma. Although it is the most common primary intraocular malignancy in adults, it is relatively rare. Up to 50% of patients with uveal melanoma eventually develop metastatic cancer, and 47% of them are HLA-A*02:01 positive. Patients who develop metastases usually have a poor prognosis, and there is no accepted best management or treatment. When cancer cells spread beyond the eyes, only about half of patients survive for one year.

The FDA's marketing approval for Kimmtrak, a bispecific TCR T cell therapy, was based on Phase III clinical data, which enrolled 378 people and showed a median overall survival (OS) of 21.7 months in the dosing group, compared to 16 months in the control group. Kimmtrak significantly prolonged overall survival and reduced the risk of death by 49%; the 1-year overall survival rate was 73.2% in the Kimmtrak-treated group compared with 58.5% in the control group.

Currently, TCR-based oncology cell therapies are being developed globally for a variety of solid tumors, including gastric cancer, cervical cancer, melanoma, synovial sarcoma, multiple myeloma and lung cancer. After decades of accumulation of innovative research and development in basic science, the global biopharmaceutical industry is entering the stage of cashing in on more new drug results, and frontier areas such as cell therapy are expected to speed up into the harvest period.

"The current form of TCR therapy that is getting a lot of attention is the very familiar TCR-T therapy. Although similar to chimeric-antigen receptor T-cell (CAR-T) therapy, TCR-T therapy is more advantageous in solid tumors, by recognizing a much larger range of potential tumor-specific antigens," as introduced by a senior scientist at Creative Biolabs, "this type of therapy now has gone from basic immune research to clinical application, showing initial efficacy in solid tumors and becoming the most likely T cell immunotherapy to make more breakthroughs in the field of solid tumors."

Creative Biolabs is a biotech company with a bispecific antibody (BsAb) team committed to providing high-quality service covering bsAb manufacturing, design, engineering analysis, etc. With a well-established bispecific TCR generation platform, Creative Biolabs provides professional bispecific TCR design and construction services.

About the Author

Candy Swift: Focus on the cutting edge biological information around the world.

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Author: Candy Swift
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Candy Swift

Member since: Nov 06, 2019
Published articles: 171

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