Atara Biotherapeutics(US:ATRA) Prnewswire·2024-02-01 07:25Core Insights - Atara Biotherapeutics and Pierre Fabre Laboratories announced significant results from the Phase 3 ALLELE study of tab-cel, showing a 51.2% objective response rate and a median duration of response of 23.0 months in patients with relapsed or refractory EBV+ PTLD [1][2][3] Group 1: Clinical Data - The ALLELE study met its primary endpoint with 22 out of 43 patients achieving an objective response, translating to a 51.2% objective response rate [2][3] - Responders had an estimated one-year overall survival of 84.4% compared to 34.8% for non-responders, with a median overall survival of 18.4 months [2][3] - The therapy was well tolerated, with no reports of serious adverse events such as tumor flare reactions or graft-versus-host disease [2][3] Group 2: Regulatory and Market Developments - Tab-cel has received marketing authorization in the EU under the brand name EBVALLO® for patients aged two years and older with r/r EBV+ PTLD [4][5] - Atara plans to submit a biologics license application (BLA) to the FDA in Q2 2024 based on the strong clinical data [1][4] - The company has expanded its partnership with Pierre Fabre for global commercialization of tab-cel, enhancing its market reach [5][6] Group 3: Industry Context - The ALLELE study results highlight the urgent need for effective treatments for patients with limited options and poor survival rates in the r/r EBV+ PTLD population [4][6] - The innovative nature of tab-cel has been recognized, contributing to its potential as a first-in-class therapy for this patient group [6]