Benzinga | Jan 4, 2021 07:38AM EST

Atara Says Has Not Yet Initiated The Biologics License Application For Tab-Cel; Remains On Track To Complete Filing In Q3, Says 'awaiting a procedural decision from the FDA related to how the historical non-pivotal data should be presented'

Company to Host Conference Call on January 4th at 8:30 a.m. EST

Atara Biotherapeutics, Inc. (NASDAQ:ATRA, the &quot, Company&quot, ))))), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with severe diseases including solid tumors, hematologic cancers and autoimmune diseases, today noted that it has not yet initiated the Biologics License Application (BLA) submission for tab-cel(r) (tabelecleucel), currently in Phase 3 development for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). The Company remains on track to complete the BLA filing in Q3 2021, based on several key points of agreement with FDA as previously announced.

To initiate the BLA, Atara is awaiting a procedural decision from the FDA related to how the historical non-pivotal data should be presented in the BLA submission. Following the FDA agreement in October 2020 that the pivotal 302 ALLELE data will be the primary basis for approval, and that historical non-pivotal clinical data will be supportive, FDA needs to decide whether they view the drug product manufactured by our academic partner used in historical, non-pivotal studies as comparable to the drug product manufactured by Atara used in the pivotal ALLELE study. This decision will then determine if the Company will submit in the clinical module the pivotal and non-pivotal data combined in pooled analyses or separately in parallel analyses. The type of analysis does not change expectations regarding the proposed product indication for previously treated patients with EBV+ PTLD.

The initial module for the rolling BLA for tab-cel(r) has been ready for submission since early December, and its content is not impacted by this decision. The Company remains on track to complete the BLA filing in Q3 2021 and is simply awaiting this procedural decision from FDA to initiate the BLA.

"Based on prior conversation with FDA, we had the understanding that this procedural decision would be made by the end of 2020 so we could initiate the BLA as planned. This procedural decision has not yet been communicated by FDA, and we look forward to continuing our constructive dialogue with the agency as part of our BTD status," said Pascal Touchon, President and Chief Executive Officer of Atara. "We remain on track to complete the BLA filing in Q3 2021."

The Company expects this procedural decision to be taken soon by FDA, based on the ongoing, constructive dialogue with the agency, which has already resulted in several key points of agreement, including: a rolling submission is acceptable for the BLA; Atara can complete the BLA submission with currently enrolled patients in the pivotal ALLELE study with at least six-months follow-up of duration of response; and, FDA will consider historical data as supportive data to the pivotal study in the BLA clinical module. Based on these discussions, the critical path to completion of the BLA remains unchanged, and the Company remains on track to complete the BLA submission in Q3 2021.

As previously announced, Atara successfully completed an interim analysis (IA) in the pivotal study for tab-cel(r) in Q3 2020 and found the data supportive of engaging with the FDA in line with stated plans to initiate a rolling BLA filing by end of 2020. The IA showed a 50 percent objective response rate (ORR) to tab-cel(r) 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 the ORR assessment. This ORR is consistent with previously published investigator assessed data. The tab-cel(r) safety profile is also consistent with previously published data, with no new safety signals.