Atara Biotherapeutics and Pierre Fabre Laboratories Announce Publication of Phase 3 ALLELE Tab-cel® Data in The Lancet Oncology

Core Insights - Atara Biotherapeutics and Pierre Fabre Laboratories announced the publication of pivotal Phase 3 ALLELE study data for tab-cel, a treatment for EBV+ PTLD, in The Lancet Oncology [1][2] Group 1: Study Results - The ALLELE study met its primary endpoint with an objective response rate (ORR) of 51.2%, as 22 out of 43 patients achieved an objective response [2][3] - Responders had a one-year overall survival rate of 84.4% compared to 34.8% for non-responders, with a median duration of response of 23.0 months and median overall survival of 18.4 months [2][3] - An updated analysis showed a statistically significant ORR of 49% and consistent durability of response [3] Group 2: Regulatory and Commercial Developments - Tab-cel received marketing authorization in the EU as EBVALLO™ for patients aged two years and older with r/r EBV+ PTLD [4] - Atara plans to submit a biologics license application (BLA) to the FDA in Q2 2024 for tab-cel [4] - A global partnership with Pierre Fabre Laboratories was expanded to cover the U.S. and other global markets for tab-cel [5] Group 3: Clinical Significance - The ALLELE study results highlight the life-saving potential of tab-cel for patients with limited treatment options and poor overall survival [4] - The treatment is recognized for its innovative nature, having received the Prix Galien prize in France [6]