USA — Adaptimmune Therapeutics has received accelerated approval from the US Food and Drug Administration (FDA) for Tecelra (afamitresgene autoleucel), marking a significant advancement in the treatment of certain cases of synovial sarcoma.
This genetically modified autologous T-cell immunotherapy targets the melanoma-associated antigen A4 (MAGE-A4), which is expressed in synovial sarcoma, a potentially life-threatening cancer.
Tecelra is specifically indicated for adults with unresectable or metastatic synovial sarcoma who are HLA-positive and whose tumors express the MAGE-A4 antigen, as confirmed by FDA-approved companion diagnostic devices.
This approval is a major milestone, supported by positive outcomes from cohort one of the mid-stage SPEARHEAD-1 trial.
In this trial, Tecelra demonstrated an overall response rate of 43% and a complete response rate of 4.5%.
The median duration of response was six months, with 39% of respondents experiencing a duration of one year or longer.
Adaptimmune’s CEO, Adrian Rawcliffe, celebrated the approval as pivotal in the company’s mission to revolutionize cancer treatment.
He highlighted that this achievement represents the culmination of a decade of pioneering research and development.
Rawcliffe expressed gratitude to the patients, caregivers, investigators, and clinical teams who contributed to this milestone, emphasizing the collective effort that made this success possible.
He committed to advancing Adaptimmune’s robust clinical pipeline, with plans to progress lete-cel, the subsequent investigational treatment in their sarcoma franchise, and to submit a rolling Biologics License Application (BLA) to the FDA next year.
Sandra D’Angelo, the Principal Investigator of the SPEARHEAD trial, highlighted that Tecelra, which utilizes each patient’s immune cells to target their cancer in a one-time infusion, represents a significant departure from current standards of care for advanced synovial sarcoma.
She noted that this approval introduces a much-needed new option for patients diagnosed with this rare cancer and marks an essential milestone for applying cell therapies in solid tumor cancers.
Prior biomarker testing is required to determine the human leukocyte antigen (HLA) type and MAGE-A4 tumor expression for Tecelra treatment.
In support of this, Adaptimmune has partnered with Agilent Technologies to provide a companion diagnostic for the MAGE-A4 biomarker, known as MAGE-A4 IHC 1F9 pharmDx.
Additionally, the FDA has approved MAGE-A4 IHC 1F9 pharmDx as a diagnostic tool to identify eligible patients with synovial sarcoma.
Adaptimmune has also collaborated with Thermo Fisher Scientific to expand the labeling of its SeCore™ CDx HLA-A Locus Sequencing System to include Tecelra.
Synovial sarcoma is a rare cancer that typically occurs near large joints and accounts for up to 10% of all soft tissue sarcomas, with approximately 13,400 new cases diagnosed annually in the US.
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