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Atara Biotherapeutics Announces Third Quarter 2020 Financial Results and Operational Progress
Interim Analysis of the pivotal 302 study (ALLELE) showed tab-cel® in EBV+ PTLD achieved a 50 percent objective response rate and safety consistent with
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\n Interim Analysis of the pivotal 302 study (ALLELE) showed tab-cel® in EBV+ PTLD achieved a 50 percent objective response rate and safety consistent with historical data \n\nDiscussions with FDA confirmed Atara can complete BLA filing with the ALLELE study’s currently enrolled patients with at least six-months follow-up for duration of response\n\nAtara plans to initiate the rolling BLA submission of tab-cel® for EBV+ PTLD by the end of 2020 and finalize the BLA submission in Q3 2021\n\nInitiated the tab-cel® Phase 2 multi-cohort study in Q3 2020 \n\nConference call to discuss results and operational highlights today at 4:30 p.m. EST\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune disease, today reported financial results for the third quarter ended September 30, 2020 and recent business highlights.\n\n“Atara is on track to finish the year strong, meeting each milestone set to date,” said Pascal Touchon, President and Chief Executive Officer of Atara. “Following an encouraging interim analysis of the pivotal Phase 3 data for tab-cel® in relapsed-refractory EBV+ PTLD and very productive interactions with regulatory authorities, we are preparing for tab-cel® submissions, and then approval and launch. We are committed to bringing this potentially life-saving therapy to the patients who acutely need it as they have no other therapeutic solution and face a very limited median life expectancy of only two to three months.”\n\nTab-cel® for Post-transplant Lymphoproliferative Disease (PTLD)\n\n\nAn Interim Analysis of the tab-cel® ALLELE study showed a 50 percent objective response rate (ORR) to tab-cel® with independent oncologic and radiographic assessment (IORA) in patients with relapsed-refractory EBV+ PTLD following hematopoietic cell transplants (HCT) or solid organ transplants (SOT), that had reached at least six months follow-up after achieving a response. This ORR is consistent with previously published investigator assessed data. The tab-cel® safety profile is also consistent with previously published data, with no new safety signals.\n\n\nIn October, working under ...