Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat certain cases of synovial sarcoma.
The regulator’s decision, which makes Tecelra the first engineered cell therapy for a solid tumour cancer to be approved in the US, specifically applies to adults with unresectable or metastatic disease who have received prior chemotherapy.
Patients eligible for the therapy will also be HLA-A02:01P, -A02:02P, -A02:03P or -A02:06P positive and will express the MAGE-A4 antigen, as determined by an FDA-approved or cleared companion diagnostic device.
Synovial sarcoma is a rare type of cancer that tends to occur near large joints and accounts for up to 10% of all soft tissue sarcomas, of which there are 13,400 new cases diagnosed in the US every year.
The disease usually affects young adults and most patients receiving standard of care treatment for advanced cases experience recurrence and go through multiple lines of therapy.
Adaptimmune’s Tecelra uses a patient’s own immune cells to recognise and attack their cancer cells via a one-time infusion and is now the first new treatment option for synovial sarcoma in more than a decade.
The US approval was supported by positive results from cohort one of the mid-stage SPEARHEAD-1 trial, in which Tecelra treatment resulted in an overall response rate of 43% and a complete response rate of 4.5%.
The median duration of response was six months and among patients who were responsive to the treatment, 39% had a duration of response of one year or longer.
SPEARHEAD principal investigator Sandra D’Angelo, Memorial Sloan Kettering Cancer Center, said Tecelra is “significantly different” from the current standards of care for advanced synovial sarcoma.
“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 tumour cancers,” D’Angelo said.
Adaptimmune said it plans to have at least six to ten authorised treatment centres for Tecelra up and running this year and to onboard about 30 centres within the first two years.
In line with the FDA’s accelerated approval pathway, continued authorisation for Tecelra in this indication may be contingent on the verification of clinical benefit in a confirmatory trial.