Atara Biotherapeutics Inc (NASDAQ:ATRA) has announced being cleared by the FDA to commence Phase 3 clinical trials with tabelecleuce used in patients with rituximab-refractory Epstein-Barr virus(EBV). EBV is highly associated with post-transplant lymphoproliferative disorder (EBV+PTLD). Atara Biotherapeutics has announced that it will be initiating these trials imminently. Tabelecleucel is the company’s off-the-shelf T-cell immunotherapy which is currently under development and will be used in the treatment of EBV+PTLD.
In a statement, the company’s Chief Executive Officer and President Isaac Ciechanover said they are highly pleased to have secured the FDA approval for the Phase 3 clinical trial of tabelecleucel. He added that this achievement came as a result of extensive collaboration and partnership with the FDA under the Breakthrough Therapy Designation. He said they hope the drug will be the first off-the-shelf T-cell immunotherapy to commence Phase 3 clinical trial in the US. Isaac said securing clearance to start these trials is a big step for the company and is expected to be a window into the company’s initial clinical sites imminently so as they are in position to serve the huge unmet need among patients with the condition.
The company will announce the results from the first tabelecleucel Phase 3 clinical trial in the first half of 2019. In addition, the company intends to submit an application for Conditional Marketing Authorization (CMA) for tabelecleucel in the European Union in the first half of 2019. The company has announced that it will be working hand in hand with Health Canada, FDA and other health authorities globally to make the drug available to patients as soon as possible.
The primary endpoint of both studies will be the confirmed objective response rate (ORR) which is defined as the percent of patients who have a reported either complete or partial response to tabelecleucel treatment and is confirmed after the first tumor assessment.
The company recently announced positive provisional results from its ongoing multicenter expanded access protocol (EAP) clinical study of tabelecleucel to be used in treating patient with EBV associated cancers. The results were announced during the 59th Annual Meeting of the American Society of Hematology (ASH).