Date: 2018-01-02
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Atara Biotherapeutics (USA - CA)
Product: tabelecleucel (formerly known as ATA129)
Action
mechanism:
- cell therapy/immunotherapy product. Tabelecleucel (formerly known as ATA129) is a potential treatment for patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+PTLD), as well as other EBV associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC).
- In February 2015, FDA granted tabelecleucel Breakthrough Therapy Designation for EBV+PTLD following allogeneic hematopoietic cell transplant (HCT) and in October 2016, tabelecleucel was accepted into the EMA Priority Medicines (PRIME) regulatory pathway for the same indication, providing enhanced regulatory support. Atara also received positive regulatory feedback from Health Canada in September 2017 supporting the submission of tabelecleucel for an expedited approval pathway. In addition, tabelecleucel has orphan status in the U.S. and EU.
Disease: rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+PTLD)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- Atara’s tabelecleucel Phase 3 program consists of two global, multicenter, open-label studies:
- for the treatment of patients with EBV+PTLD following allogeneic hematopoietic cell transplant (HCT) after failure of rituximab (MATCH), and
- - for the treatment of patients with EBV+PTLD following solid organ transplant (SOT) after failure of rituximab or after failure of rituximab plus chemotherapy (ALLELE).
- The primary endpoint of both the MATCH and ALLELE studies is the confirmed objective response rate (ORR), defined as the percent of patients achieving either a complete or partial response to tabelecleucel treatment confirmed after the initial tumor assessment showing a response. The protocols are designed to rule out 20% ORR as the null hypothesis. For example, assuming anticipated enrollment of 35 patients in MATCH, an ORR above approximately 37% would be expected to meet the primary endpoint.
- In ALLELE, each of two cohorts with an anticipated enrollment of 35 patients will be analyzed independently using the same statistical methodology.
- Secondary endpoints for both the MATCH and ALLELE studies include duration of response, overall survival, safety, quality of life metrics, and other data in support of potential health economic benefits.
Latest
news:
- • On January 2, 2018, Atara Biotherapeutics announced initiation of two Phase 3 clinical studies to evaluate tabelecleucel (formerly known as ATA129) in patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+PTLD). Three clinical sites for both the MATCH and ALLELE pivotal studies are now open for enrollment in the U.S. and the studies will later expand to additional U.S. sites as well as sites in the EU, Canada and Australia.
- Results from the first tabelecleucel Phase 3 study to reach the primary endpoint are expected to be announced in the first half of 2019. Atara also plans to submit a tabelecleucel Conditional Marketing Authorization (CMA) application in the EU for patients with rituximab-refractory EBV+PTLD following HCT during the first half of 2019. In addition, Atara plans to continue working closely with the FDA, Health Canada and other global health authorities to make tabelecleucel available to patients as expeditiously as possible.
- • On December 29, 2017, Atara Biotherapeutics announced that it received clearance from the FDA to initiate two Phase 3 clinical studies with tabelecleucel (formerly known as ATA129) in patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+PTLD). The company plans to initiate these studies imminently. Atara’s tabelecleucel Phase 3 program consists of two global, multicenter, open-label studies:
- – for the treatment of patients with EBV+PTLD following allogeneic hematopoietic cell transplant (HCT) after failure of rituximab (MATCH), and
– for patients with EBV+PTLD following solid organ transplant (SOT) after failure of rituximab or after failure of rituximab plus chemotherapy (ALLELE).
The Phase 3 studies are expected to open for enrollment in the U.S. imminently and will later expand to include sites in the EU, Canada and Australia.
Is
general: Yes
