Date: 2017-11-12
Type of
information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 59th American Society of Hematology (ASH) Annual Meeting in Orlando
Company: Atara Biotherapeutics (USA - CA)
Product: tabelecleucel (formerly known as ATA129)
Action
mechanism:
- cell therapy/immunotherapy product. Tabelecleucel is Atara's off-the-shelf T-cell immunotherapy in development for the treatment of Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+PTLD), as well as other EBV associated hematologic and solid tumors.
Disease: EBV associated cancers
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On December 11, 2017, Atara Biotherapeutics announced that the company's collaborating investigators presented updated, positive interim results for tabelecleucel (formerly known as ATA129) from a multicenter expanded access protocol (EAP) study for patients with EBV associated cancers. The findings were reported at the ongoing 59th American Society of Hematology (ASH) Annual Meeting. Updated efficacy findings were presented:
- In 6 patients with rituximab-refractory EBV+PTLD following solid organ transplant (SOT) the Objective Response Rate (ORR) was 83%, with 5 of 6 patients responding to treatment.
Additionally, in 5 patients with rituximab-refractory EBV+PTLD following allogeneic hematopoietic cell transplant (HCT) an ORR of 80% was observed, with 4 of 5 patients responding to treatment.
An additional patient with EBV+PTLD following HCT remains alive, but was not evaluable due to lack of post-baseline assessment.
The estimated one-year overall survival for the 12 tabelecleucel treated patients with EBV+PTLD following HCT or SOT, was 90.9% [95% confidence interval (50.8%, 98.7%)].
Updated safety findings were reported for a total of 23 patients, including an additional 11 patients with other EBV associated cancers who were included in the safety analysis:
- Tabelecleucel was generally well-tolerated in this study population, which comprised quite ill, mostly immunosuppressed patients with multiple comorbidities.
5 patients experienced treatment-related serious adverse events (SAEs).
One HCT patient died due to PTLD disease progression.
Two possibly related cases of graft-versus-host disease (GvHD) in patients with EBV+PTLD following HCT were reported.
A tumor flare was observed in one patient with EBV+ HIV-associated plasmablastic lymphoma that resolved without clinical sequelae.
Is
general: Yes
