Adaptimmune has announced the FDA approval of Tecelra, making it the first engineered cell therapy to receive approval for a solid tumor indication and the first T cell receptor (TCR) therapy to enter the US market. With this approval, Tecelra also becomes the first new treatment option in more than a decade for people with synovial sarcoma, a rare soft tissue cancer that most commonly impacts young adults.
“For decades, therapeutic options for people diagnosed with synovial sarcoma have been limited. With a current five-year survival rate as low as 36%, and for those with metastatic disease at diagnosis, as low as 20%, it is long past time that synovial sarcoma patients have expanded treatment options,” said Brandi Felser, Chief Executive Officer of the Sarcoma Foundation of America. “Since one third of patients are diagnosed under age 30, improved outcomes can have a tremendous impact. Today, there is a renewed sense of hope for this patient community.”
Tecelra (afamitresgene autoleucel) is a genetically modified T cell immunotherapy made from a patient’s own white blood cells, which are engineered to recognize and attack cancer cells. The treatment is approved for the treatment of unresectable or metastatic synovial sarcoma in adults that pass certain prerequisites, including having previously received chemotherapy, carrying certain human leukocyte antigen (HLA) types, and expressing the MAGE-A4 tumor antigen.
Since biomarker tests are required to receive Tecelra, Adaptimmune has partnered with Thermo Fisher Scientific and Agilent Technologies to manufacture and supply companion tests for HLA and MAGE-A4 tumor expression, respectively.
“Milestone for the use of cell therapies in solid tumor cancers.”
The accelerated approval status was granted to Tecelra based on data from the SPEARHEAD-1 trial, which included 44 patients. The overall response rate for patients treated with a one-time infusion of Tecelra was 43%, with a median duration of six months.
The continuation of the approval will hinge on the verification of the treatment’s clinical benefit in a confirmatory trial that is currently ongoing, with results expected next year.
“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, principal investigator of the SPEARHEAD trial at the Memorial Sloan Kettering Cancer Center
As is the case with other cell therapies, Tecelra will only be available at certain authorized treatment centers (ATC). Adaptimmune plans to have between six to ten ATCs up and running this year, and to onboard about 30 treatment centers within the first two years. The company will also be offering an integrated support program to accompany patients, caregivers and healthcare providers through the whole treatment journey.
“The approval of Tecelra is a momentous step in Adaptimmune’s journey to redefine the way cancer is treated and the culmination of a decade of groundbreaking R&D,” said Adrian Rawcliffe, Chief Executive Officer at Adaptimmune. “We are committed to advancing our robust clinical pipeline to serve more patients in need and plan to progress lete-cel, the next late-stage investigational treatment in our sarcoma franchise, with a rolling BLA submission to the FDA next year.”