Photo Credit: Meletios Verras
This phase 3 multicenter trial demonstrated the efficacy and safety of tabelecleucel in patients with EBV-related post-transplant lymphoproliferative disease, showing increased objective response rates at 5-year follow-up and a 70% landmark 1-year survival rate, supporting its potential as a treatment option.
1. Tabelecleucel provided clinical improvement in patients with EBV-related post-transplant lymphoproliferative disease.
2. There were no fatal treatment related adverse events in those treated with tabelecleucel.
Evidence Rating Level: 1 (Excellent)
Study Rundown: The present study was a phase 3 multicenter trial that assessed the impact of tabelecleucel (a T-cell based immunotherapy directed against EBV) on patients with EBV-related post-transplant lymphoproliferative disease. Patients included in the trial had EBV-positive post-transplant disease. Patients included in the study had either experienced disease relapse or were resistant to rituximab treatment after receiving a hematopoietic stem-cell transplant (HSCT), or they had received rituximab therapy with or without chemotherapy following a solid organ transplant. All patients included were placed on a tabelecleucel regimen. This study found that those that received the tabelecleucel regimen had increased objective response rates at 5-year follow-up. The landmark 1-year survival rate was 70%. Further, the study assessed safety and noted that no fatal adverse events occurred secondary to tabelecleucel. Strengths of this study include that it is a global multicenter trial, allowing for generalization of the trial findings. Limitations of this trial include that given the rare population studied, the studies had a small sample size, and was a single-armed with no placebo control. This trial overall lends evidence towards the use of tabelecleucel in EBV-related post-transplant lymphoproliferative disease.
Click to read the study in The Lancet Oncology
In-Depth [prospective cohort]: The present study is a multicenter phase three trial that assesses the impact of tabelecleucel in relapsed EBV-positive post-transplant lymphoproliferative disease. Patients included in the analysis had relapsed disease; they were either resistant to rituximab treatment following HSCT or had undergone rituximab therapy with or without chemotherapy, after a solid organ transplant. A total of 63 patients were enrolled in the trial and placed on a tabelecleucel regimen. No control group was included in the trial. The primary endpoint of the study was the complete objective response rate to treatment. Objective treatment response was 50% (95% CI 23–77) and 52% (CI 33–71) in the HSCT group and solid-organ transplant group, respectively. Importantly, no treatment related deaths were noted. Overall, this trial indicates that tabelecleucel treatments yield favourable clinical outcomes with one of the best evidence for treatment for this rare population.
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