Dr. Beitinjaneh on the Evaluation of Tabelecleucel in EBV+ Hematologic Malignancies

Amer M. Beitinjaneh, MD, associate professor of Clinical Medicine, the University of Miami Health System, Sylvester Comprehensive Cancer Center, discusses updated results from phase 3 ALLELE trial (NCT03394365) investigating the use of tabelecleucel (Ebvallo) in Epstein-Barr Virus (EBV)–positive post-transplant lymphoproliferative disease following allogeneic hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) after failure of rituximab (Rituxan) with or without chemotherapy.

Overall response rate (ORRs) served as the trial’s primary end point, and updated data presented at the 2023 Transplantation and Cellular Therapy Meetings showed that the ORR for the overall population was 51.2% with a complete remission (CR) rate of 27.9%. Among patients who had post-transplant lymphoproliferative disease following allogeneic HSCT, the ORR was 50% and the CR rate was 42.9%, Beitinjaneh explains.

Partial responses and CRs were durable, and the overall median duration of response was 23 months, Beitinjaneh adds. The time to response in the overall group was 1 month, indicating that these results pointed to quick, durable, and good response rates for patients who do not typically respond well to treatment in the second or third line, Beitinjaneh continues.

Additionally, the median overall survival (OS) for the whole group of patients was 18.4 months, and the median OS was not estimable for patients who received prior HSCT. Patients with EBV-positive post-transplant lymphoproliferative disease typically have an OS of less than 6 months, Beitinjaneh explains; however, the estimated 1-year OS rate for patients who responded to treatment was 84.4% for the overall population and 100% for the post-HSCT population.

Notably, when examining other patient factors such as age, race, gender, ECOG performance status, or number of prior therapies, none were associated with worse response to the treatment with tabelecleucel, Beitinjaneh concludes.