Tecelra®, the first engineered T-cell therapy for solid tumors, has received approval from the Food and Drug Administration (FDA) for advanced MAGE-A4+ synovial sarcoma in adults with specific human leukocyte antigen (HLA) types who have received chemotherapy, marking a significant milestone in cancer treatment. This groundbreaking therapy, developed by Oxford, England-based Adaptimmune, targets metastatic or unresectable synovial sarcoma, a rare and aggressive form of cancer. Tecelra not only represents the first T-cell receptor therapy to receive approval, but it also is Adaptimmune’s first approved therapy. “Ninety percent of cancer is solid tumors,” John Lunger, Adaptimmune’s chief patient supply officer, told Fierce Pharma. “The idea of a company like ourselves, going after solid tumors using cells, we’re finally getting to that place where we’re demonstrating this can actually work.”
Pioneering a New Approach
Tecelra’s approval is a watershed moment for Adaptimmune, a company that has weathered partnerships and challenges over its 16-year journey. “It’s the first product where we use a lentiviral vector to insert our engineered T-cell receptor into the cell,” explained Lunger. This method stands apart from other therapies, such as CAR-T and tumor-infiltrating lymphocytes, by harnessing the power of genetically engineered T-cells to seek out and destroy solid tumors, a feat long considered elusive in cancer treatment.
Rare Cancer, Positive Results
Tecelra targets a small but critical patient population, estimated at 400 people in the US annually. Sarcomas are rare cancers of the bones and tissues, often affecting young adults. The five-year survival rate for synovial sarcoma is as low as 36% and can decline to 20% for patients with metastatic disease at diagnosis, according to Adaptimmune.
The FDA’s approval of Tecelra is based on the results of SPEARHEAD-1, a Phase II clinical trial involving 44 patients. Results were previously published in the Lancet. Trial results showed a 43% overall response rate and a complete response rate of 4.5%. The median duration of response was 6 months. Among patients who were responsive to the treatment, 39% had a duration of response of 12 months or longer.
A confirmatory trial will be required as a condition of the accelerated approval. “We’ve also seen for those responders about a 70% chance that they’re still alive after two years and that data is still developing,” Lunger said. Despite the potential for serious side effects, including cytokine release syndrome and neurotoxicity, Tecelra’s one-time treatment, priced at $727,000 in the US, offers a stark contrast to the usual treatment regimen. “From the patient experience, when you compare what we have with a one-time therapy to the usual standard of care—chemotherapy, radiation and surgery—it’s extraordinary,” Lunger said.
A Company Reborn
Adaptimmune’s path to this breakthrough was far from smooth. Earlier this year, the company faced a significant setback when Genentech withdrew from a $3 billion partnership. However, just 7 weeks later, the company secured a $665 million deal with Galapagos, a Belgian biotech firm. This deal, which includes $100 million upfront, provides crucial funding for the launch of Tecelra and fuels further research into similar therapies.
Looking Ahead
Tecelra’s approval is just the beginning. Adaptimmune plans to establish 6 to 10 treatment centers in the US by the end of the year, with a goal of expanding to 30 centers by the end of 2025. As the company works to advance cell therapies for patients with other types of solid tumor cancers, it hopes to pave the way forward against some of the most challenging cancers. “This approval represents a much-needed new option for people diagnosed with this sarcoma and an important milestone for the use of cell therapies in solid tumor cancers,” said Sandra D’Angelo, the principal investigator of the SPEARHEAD trial.
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