Syncona’s Autolus presents new clinical data
Autolus Therapeutics 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 of relapsed / refractory adult B-Acute Lymphocytic Leukemia (ALL), at the European Hematology Association EHA25 Virtual Congress beginning June 11.
AUTO1 in ALL
As of the data cut-off date of May 13, 2020, 19 patients had received AUTO1. AUTO1 was well tolerated, with no patients experiencing ≥ Grade 3 CRS. Three patients (16%) with high leukemia burden (>50% blasts) experienced Grade 3 neurotoxicity that resolved swiftly with the application of steroids. Of the 19 patients, 16 (84%) achieved MRD-negative CR. Two out of 16 patients received a transplant while in remission and CD19-negative relapse occurred in 3 (16%) patients. Durability of remissions is encouraging. Event Free Survival (EFS) and Overall Survival (OS) at 6 months are 62% and 72% respectively in all patients, and 76% and 92% respectively in the 13 patients treated with the closed (commercial) process. Median EFS and OS has not been reached, at a median follow up of 12.2 months (range up to 24.4 months).
“I am very encouraged by the tolerable safety profile and high level of sustained CRs we have observed with AUTO1 in the ALLCAR19 study that was achieved without subsequent stem cell transplant,” said Dr. Claire Roddie, Consultant Hematologist, UCL Cancer Institute and University College London Hospital.
“Approximately 60% of adult ALL patients relapse or are refractory to first line therapy and there continues to exist a high unmet need,” said Dr. Michael Bishop, MD, Professor of Medicine and Director of the Cellular Therapy Program at University of Chicago Medicine. “AUTO1 is a novel CD19 CAR T candidate with a compelling activity and safety profile and has the potential to change standard of care as a curative therapy for r/r ALL.”
“The data update on AUTO1 presented at this year’s EHA meeting show an encouraging durability of response without subsequent stem cell transplant and confirm the positive safety profile.” said Dr. Christian Itin, chairman and chief executive officer of Autolus. “We have started enrolment of patients with r/r aALL in our pivotal Phase 1b/2 AUTO1-AL1 study.”
AUTO3 in DLBCL
Dr. Wendy Osborne presented ALEXANDER Phase 1/2 clinical trial data for AUTO3. This data is consistent with our update on May 29, 2020, with a data cut-off date of April 27, 2020.
“These data are very encouraging, in terms of safety and tolerability, with a high level of clinical activity,” said Dr. Wendy Osborne, Consultant Hematologist, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust. “We are looking forward to enrolling additional patients in the outpatient cohort.”