On June 11, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported a poster presentation related to AUTO1 (obecabtagene autoleucel, obe-cel) in relapsed / refractory (r/r) indolent B cell lymphomas (IBCL) and included an update of duration of response in r/r adult Acute Lymphoblastic Leukemia (ALL) patients at the European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress 2021 (Press release, Autolus, JUN 11, 2021, View Source [SID1234583908]).

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"The stabilization of event-free survival at 50% between 12 months and 24 months of follow-up supports the curative potential of obe-cel as a standalone therapy for some adult ALL patients," said Dr. Christian Itin, chief executive officer of Autolus. "The early data we presented in indolent B cell non-Hodgkin lymphoma indicate a high level of clinical activity combined with a manageable safety profile and could represent a significant opportunity to expand the benefits of obe-cel treatment to a broader population of patients with B cell malignancies."

Title: Early safety and efficacy findings of AUTO1 (CAT19), a fast-off rate CD19 CAR, in Relapsed/Refractory Indolent B Cell Lymphomas

Presenter: Clare Roddie, MD, PhD, FRCPath, Consultant Haematologist and Honorary Senior Lecturer, Cancer Institute, University College London (UCL)

Session Date and Time: Friday, June 11, 2021 at 9.00 a.m. CEST

Relapsed / refractory (r/r) indolent B cell lymphomas
As of the data cut-off date of May 17, 2021, 13 patients in Cohort D with r/r IBCL had been enrolled in the study and product was successfully manufactured for 12 patients, with one patient’s cells ongoing in manufacture. As of the data cut-off date, 9 r/r IBCL patients had received AUTO1 infusion. Three patients were pending infusion (including the patient noted above) and one patient died prior to lymphodepletion due to a Covid-19 infection. Obe-cel was well tolerated and demonstrated a favorable safety profile in adult patients with r/r low grade B-cell lymphoma, despite high disease burden. All treated patients achieved a complete metabolic remission and had robust CAR T engraftment, expansion, and persistence.

Grade 1 cytokine release syndrome (CRS) was reported in 4 patients and Grade 2 CRS in 1 patient. No immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade was observed in the study. At a median follow-up of 6 months (range 4.0-8.1m), eight of nine patients were disease free at last follow-up with one patient who relapsed at month 6 but was rescued with radiotherapy. One patient died of a COVID-19 infection at month 5.6 whilst in complete metabolic remission.

Relapse / refractory adult Acute Lymphoblastic Leukemia
As of the data cut-off date of May 17, 2021, 20 patients in Cohort A with r/r ALL had received obe-cel. The therapy was well tolerated, with no patients experiencing Grade 3 or higher CRS. Three patients (15%), all of whom had high leukemia burden (>50% blasts), experienced Grade 3 ICANS that resolved swiftly with steroids.

Of the 20 patients evaluable for efficacy, 17 (85%) of patients achieved minimum residual disease (MRD)-negative complete remission (CR) at one month. Most notably, the durability of remissions is highly encouraging. Across all treated patients, event free survival (EFS) at twelve months and twenty-four months is 50.2% with median EFS not being reached.

Conference Call
Management will host a conference call and webcast today at 8:30 am ET/1:30 pm BST to discuss the data presented at EHA (Free EHA Whitepaper). To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 3697562. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 3697562.