Atara Bio has reached an agreement with the FDA over the design of two phase III trials, each investigating ATA 129.
Atara Bio has reached an agreement with the FDA over the design of two phase III trials, each investigating ATA 129. The treatment is designed to treat rituximab-refractory EBV-associated post transplant lymphoproliferative disorder.
According to the press release:
“The primary endpoint of both the MATCH and ALLELE trials is objective response rate, defined as the percent of patients achieving either a complete or partial response to treatment with ATA 129. Secondary endpoints for both trials include duration of response, overall survival, safety, quality of life metrics, and other data in support of potential health economic benefits.”
Issac Ciechanover, CEO of Atara Bio, said the following:
“Agreement on the Phase 3 trial designs is an important step in the development of ATA 129. We look forward to bringing this potentially important new therapy to patients with such significant unmet need.”