NEW YORK – The US Food and Drug Administration on Thursday granted accelerated approval to Adaptimmune's autologous T-cell receptor (TCR) therapy Tecelra (afamitresgene autoleucel) for certain patients with previously treated metastatic synovial sarcoma.
To be eligible for treatment, patients' tumors must express the MAGE-A4 antigen and have one of four human leukocyte antigen types: HLA A*02:01P, HLA A*02:02P, HLA*02:03P, or HLA*02:06P. Alongside Tecelra, the FDA approved Agilent Technologies' MAGE-A4 IHC 1F9 PharmDx as a companion diagnostic to select MAGE-A4-positive synovial sarcoma patients who can receive the autologous therapy. Adaptimmune has also partnered with Thermo Fisher Scientific to expand the label of the already approved HLA-A-typing test, SeCore CDx, so that it can be used to identify patients with the specified HLA types for Tecelra therapy.
Tecelra is the second autologous cell therapy approved in the US for a solid tumor indication, and the first such engineered treatment to enter the solid tumor space. Iovance Biotherapeutics' unselected autologous tumor-infiltrated lymphocyte therapy Amtagvi (lifileucel), which received commercial approval for advanced melanoma patients in February 2024, was the first autologous cell therapy approved for a solid tumor indication.
Treatment with Tecelra involves harvesting patients' own T cells, modifying them to express a TCR that targets MAGE-A4, then infusing them as a one-time treatment. The firm's list price for Tecelra is $727,000 dollars per infusion.
The FDA granted accelerated approval after reviewing results from cohort 1 of the Phase II SPEARHEAD-1 clinical trial, in which 43.2 percent of advanced, MAGE-A4-positive synovial sarcoma patients responded to Tecelra, and the median duration of response was six months.
"This is a watershed day for Adaptimmune and for the cell therapy field, but most importantly for the sarcoma community," Adaptimmune CEO Adrian Rawcliffe said on a conference call to discuss the approval on Friday morning. He noted that Adaptimmune is already onboarding authorized treatment sites where patients can receive Tecelra, called Sarcoma Centers of Excellence. The firm aims to onboard 30 of these centers over time. "We believe this will allow us to supply Tecelra to every eligible US patient," Rawcliffe said.
As a condition of receiving accelerated approval for Tecelra, Adaptimmune must confirm its safety and efficacy in additional studies, a requirement the company expects to fulfill by testing the therapy's activity in other SPEARHEAD-1 cohorts.