Aug. 5, 2024—Adaptimmune Therapeutics announced FDA accelerated approval for Tecelra (afamitresgene autoleucel) for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, ‑A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or FDA-cleared companion diagnostic devices. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory trial.
The approval was based on results of the SPEARHEAD-1 trial, cohort one, which included 44 patients. The major efficacy outcome was overall response rate (ORR) determined by independent review and supported by duration of response. Tecelra treatment resulted in an ORR of 43 percent with a complete response rate of 4.5 percent. The median duration of response was six months (95 percent confidence interval, 4.6, not reached). Among patients who were responsive to the treatment, 39 percent had a duration of response of 12 months or longer.
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