Autolus Therapeutics presents compelling AUTO1 data from ALLCAR Phase 1 study in Adult Acute Lymphoblastic Leukemia (ALL) during the 62nd ASH Annual Meeting

Updated data from the ALLCAR study suggests AUTO1’s potential for transformational activity in adult patients with r/r ALL

Conference call and webcast to be held Monday, December 7, 2020 at 4:00 pm ET / 9:00 pm GMT

LONDON, Dec. 05, 2020 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced new data highlighting progress on its AUTO1 program, the company’s CAR T cell therapy being investigated in the ongoing ALLCAR Phase 1 study in relapsed / refractory adult B-Acute Lymphocytic Leukemia (ALL), during the American Society of Hematology (ASH) All-Virtual Annual Meeting, held between December 5-8, 2020.

As of the November 12, 2020 data cut-off date, 20 patients with r/r ALL had received AUTO1. AUTO1 was well tolerated, with no patients experiencing ≥ Grade 3 cytokine release syndrome (CRS). Three patients (15%), all of whom had high leukemia burden (>50% blasts), experienced Grade 3 neurotoxicity (NT) that resolved swiftly with steroids.

Of the 19 patients evaluable for efficacy, 16 (84%) patients achieved minimum residual disease (MRD)-negative complete response (CR) at one month. Most notably, the durability of remissions is highly encouraging. Across all treated patients, event free survival (EFS) at six and 12 months is 69% and 52% respectively. Median EFS and overall survival (OS) has not been reached at a median follow up of 16.9 months (range up to 30.5 months).

“The high level of sustained CRs observed with AUTO1 in adult ALL, achieved without subsequent stem cell transplant, point to a potentially transformational treatment for adult ALL,” said Dr. Claire Roddie, Consultant Hematologist, UCL Cancer Institute and University College London Hospital. “Despite high disease burden and despite this being a heavily pre-treated patient population on study, AUTO1 remains well tolerated. It’s encouraging to also observe promising early activity and safety in indolent NHL.”

“Adult ALL is a disease with high unmet need, whereby approximately 60% of patients relapse or are refractory to first line therapy,” said Dr. Elias Jabbour, Professor of Leukemia at The University of Texas MD Anderson Cancer Center. “AUTO1 is a novel CD19 CAR T candidate with an impressive clinical profile.  This profile has the potential to change standard of care as a curative therapy for r/r ALL.”