HQ Team
August 4, 2024: UK-based biopharmaceutical company, Adaptimmune Therapeutics Plc, got FDA approval for its cell therapy for treating a rare form of cancer.
The USFDA gave its `accelerated approval’ for the company’s Tecelra or afamitresgene autoleucel for treating adults with metastatic synovial sarcoma and who have received prior chemotherapy, according to a company statement.
Metastatic synovial sarcoma is a rare, aggressive form of soft tissue cancer that can spread early and commonly occurs in the lungs and lymph nodes:
“Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial,” according to the statement.
Engineered cell therapy
The therapy is the first engineered cell therapy for a solid tumour cancer approved in the US, and the first new therapy option in more than a decade for synovial sarcoma.
Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer said the therapy resulted from a decade of research and development.
“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.”
The approval was based on the results of a trial, which included 44 patients. The overall response rate, determined by an independent review, was 43%, with a complete response rate of 4.5%.
Median duration
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.
The overall response rate, or the objective response rate, is the percentage of patients in a study or treatment group who respond to treatment within a certain period.
In cancer clinical trials, the rate is a way to measure how well a new treatment works by determining the proportion of patients whose cancer shrinks or disappears after treatment.
A complete response indicates the patient has no detectable evidence of a tumour over a specified period.
“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, Sarcoma Foundation of America.
One-time infusion
“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 uses each patient’s immune cells to recognise and attack their cancer cells in a one-time infusion treatment.
“It is significantly different from the current standard of care for advanced synovial sarcoma,” said Sandra D’Angelo, MD, Sarcoma Medical Oncologist and Cell Therapist, Memorial Sloan Kettering Cancer Center and the trial’s principal investigator:
