1. Overall response rate to afami-cel in both groups was 37%.

2. The majority of adverse-events were moderate in nature with no treatment-related deaths.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Synovial sarcoma and myxoid round cell liposarcoma are rare, chemo-refractory malignancies with a poor prognosis once metastasized. Current treatment regimens are limited, and a more effective form of T-cell therapy is required. This randomized controlled trial aimed to evaluate the safety and efficacy of afamitresgene autocel (afami-cel), an autologous CD4+ and CD8+ T-cell therapy, in patients with HLA-A*02 and MAGE-A4-expressing synovial sarcoma and myxoid round cell liposarcoma. The primary outcome of this study was overall response rate while key secondary outcome included treatment-related adverse events. According to study results, afami-cel effectively targeted HLA-A*02 and MAGE-A4 tumors, producing durable treatment responses. Although this study was well done, it was limited by its non-randomized design and relatively small sample size, affecting the validity of findings.

Click to read the study in The Lancet

Relevant Reading: Atezolizumab for Advanced Alveolar Soft Part Sarcoma

In-depth [randomized controlled trial]: Between Dec 17, 2019, and Jul 27, 2021, 373 patients were screened for eligibility across 23 sites in Canada, the USA, and Europe. Included were patients aged 16–75 years with HLA-A*02 or MAGE-A4-expression, who had received prior chemotherapy. Altogether, 52 patients (44 with synovial sarcoma and 8 with round cell liposarcoma) were included in the final analysis. Primary outcome of overall response rate was 37% (95% confidence interval [CI] 24-51); 39% in synovial sarcoma (95% CI 24-55) and 25% in myxoid round cell liposarcoma (95% CI 3-65). Cytokine release syndrome (71%) and cytopenias (96% lymphopenia, 85% neutropenia, 81% leukopenia) were the most common grade 3 adverse events, with no treatment-related deaths. Findings from this study suggest that afami-cel treatment provides promising efficacy in targeting solid tumors, paving the way for its potential expansion to other malignancies.

Image: PD

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