FDA approves T-cell immunotherapy for advanced synovial sarcoma
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The FDA granted accelerated approval to afamitresgene autoleucel for certain adults with unresectable or metastatic synovial sarcoma.
The indication applies to patients who received prior chemotherapy, are HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P or HLA-A*02:06P positive and whose tumor expresses the MAGE-A4 antigen.
Afamitresgene autoleucel (Tecelra, Adaptimmune LLC) is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy.
The FDA based approval on results from one cohort of the multicenter, single-arm SPEARHEAD-1 trial.
The trial included HLA-A*02:01-03 and 06 allele-positive patients with inoperable or metastatic synovial sarcoma. All study participants had received prior systemic therapy with doxorubicin or ifosfamide, and their tumors expressed MAGE-A4.
Fifty-two patients underwent leukapheresis. Forty-four underwent lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by a single infusion of afamitresgene autoleucel.
Overall response rate per independent review served as the main efficacy outcome.
Researchers reported an ORR of 43.2% (95% CI, 28.4-59), with median time to response of 4.9 weeks (95% CI, 4.4-8) and median response duration of 6 months (95% CI, 4.6 to not reached).
Among patients who responded to treatment, 45.6% remained in response for at least 6 months and 39% remained in response for at least 12 months.
The most common grade 3 or grade 4 laboratory abnormalities included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell count and platelet count.
The most common nonlaboratory adverse events included cytokine release syndrome, nausea, vomiting, infectious, fatigue, pyrexia, dyspnea, constipation, abdominal pain, decreased appetite, noncardiac chest pain, tachycardia, hypotension, back pain, diarrhea and edema.
Afamitresgene autoleucel includes a boxed warning for serious or fatal cytokine release syndrome.
Per postmarketing requirements, another study is ongoing to verify the clinical benefit of afamitresgene autoleucel for adults with unresectable or metastatic synovial sarcoma who received prior chemotherapy, are HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P or HLA-A*02:06P positive, and whose tumor expresses MAGE-A4.
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