On December 12, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the online publication of three posters with updates from three Phase 1 clinical trials to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 10-13, 2022 (Press release, Autolus, DEC 12, 2022, View Source [SID1234625274]).
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"With three years of median follow-up in our Phase 1 ALLCAR19 study we see 35% of adult relapsed/refractory B-ALL patients treated with obe-cel in sustained complete remissions between 24 and 47 months without any need for additional anti-leukemia therapy. Remarkably, these patients in long term remissions also have long-term persisting CAR T cells, a unique feature of obe-cel," said Dr. Christian Itin, Chief Executive Officer of Autolus. "With the initial data from the pivotal Phase 2 FELIX trial tracking the outcome of our previous ALLCAR19 trial, we are excited about the potential prospects of obe-cel in adult ALL patients and look forward to presenting the full data of the FELIX study in mid-2023. The potentially best-in-class profile of obe-cel is supported by the data we have observed in NHL, with continued high levels of clinical activity paired with an encouraging tolerability profile across DLBCL, MCL, FL and CLL."
"It’s great to be presenting clinical updates for AUTO1/22 in pediatric B-ALL and AUTO4 in peripheral T Cell Lymphoma. AUTO1/22 shows encouraging response rates in patients ineligible for commercial CAR T therapy, with 83% of patients achieving MRD negative complete responses. Importantly, we have not observed antigen negative relapse," said Dr. Martin Pule, Chief Scientific Officer at Autolus. "In the AUTO4 study, some patients have experienced durable metabolic CRs, including one patient up to the one-year mark. This is a notable finding given the poor prognosis of relapsed/refractory T cell lymphomas."
Conference Call
Management will host a conference call and webcast at 10:30 am ET/3:30 pm GMT to summarize the ASH (Free ASH Whitepaper) data. The webcast can be accessed at this link.
A simultaneous audio webcast and replay will be accessible on the events section of Autolus website.
Posters to be presented:
Title: Safety, Efficiency and Long-Term Follow-up of AUTO1, a Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia (B-ALL) and Other B-Cell Malignancies
LINK to poster
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
Session date and time: Sunday, December 11, 2022, 6:00 PM – 8:00 PM
Session room: Ernest N. Morial Convention Center, Hall D
Publication Number: 3318
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Consultant Haematologist and Honorary Senior Lecturer, Cancer Institute, University College London (UCL)
Summary: In the B-ALL cohort, 7 out of 20 (35%) patients were observed to be in ongoing Complete Remission (CR) at median follow up of 36 months (IQR 24-47) post-AUTO1 without the need for additional anti-leukemia therapy. Ongoing long-term remissions appear to be associated with CAR-T persistence, which was also observed in these 7 patients at their last follow-up. One patient with a subsequent stem cell transplant (SCT) also achieved long term remission but lost CAR T persistence after SCT. In the B-cell non-Hodgkin lymphoma/chronic lymphocytic leukemia (NHL/CLL) cohorts, AUTO1 continues to display a favorable tolerability profile with no immune effector cell-associated neurotoxicity syndrome (ICANS) or Grade ≥ 3 cytokine release syndrome (CRS) across different indications. Of 25 patients with NHL/CLL evaluable for efficacy, the best overall response rate (ORR) was 23/25 (92%). AUTO1 was observed to be well-tolerated and active in diffuse large B-cell lymphoma (DLBCL), with 7 of 8 patients in ongoing CR at last follow-up. In CLL, 4 of 5 treated patients achieved undetectable minimal residual disease (uMRD) in the bone marrow (BM), ongoing at last follow-up. While no relapses were seen in DLBCL patients, late CD19+ relapses were seen in follicular lymphoma (FL), and ongoing CAR-T persistence appears to be important.
Title: Dual Antigen Targeting with Co-Transduced CD19/22 CAR T Cells May Prevent Antigen-Negative Relapse after CAR T Cell Therapy for Relapsed/Refractory ALL (AUTO1/22)
LINK to poster
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III
Session date and time: Monday, December 12, 2022, 6:00 PM – 8:00 PM
Session room: Ernest N. Morial Convention Center, Hall D
Publication Number: 4650
Presenting Author: Dr. Sara Ghorashian, MD, PhD, Hon clinical senior lecturer, UCL Great Ormond Street Institute of Child Health
Summary: AUTO1/22 demonstrated a strong level of activity with 83% (10/12) MRD negative complete remissions and a favorable tolerability profile in a very challenging patient population (4 patients failed previous Kymriah treatment with three having CD19-negative disease, 3 had non-central nervous system (CNS) extra-medullary disease, which is associated with poor outcomes with CAR T therapy). AUTO1/22 showed excellent expansion, with a median 7.5 months duration of persistence of CD22 CAR. No antigen negative relapse was seen in responding patients. At a median follow up of 8.7 months, five of 10 responding patients were in MRD negative complete response (4-12 months) with two after further therapy for early loss of CAR T persistence.
Title: First in Human Study of AUTO4, a TRBC1-Targeting CAR T-Cell Therapy in Relapsed/Refractory TRBC1-Positive Peripheral T-Cell Lymphoma
LINK to poster
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III
Session date and time: Monday, December 12, 2022, 6:00 PM – 8:00 PM
Session room: Ernest N. Morial Convention Center, Hall D
Publication Number: 4634
Presenting Author: Dr Kate Cwynarski, Consultant Haematologist University College London Hospitals (UCLH)
Summary: Having shown proof of concept at EHA (Free EHA Whitepaper) in June 2022, AUTO4 treatment for peripheral T-cell Lymphoma continues to be observed to be well tolerated with no dose-limiting toxicities. Ongoing responses at 9- and 12-months post-dosing at the highest dose tested (450×106) are encouraging, and suggests a potential clinical benefit for patients. No CAR T cell expansion was observed in peripheral blood, but CAR T cells were detected in an on-treatment lymph node biopsy. Optimization of the AUTO4 manufacturing process has been performed, resulting in a product candidate with a more naive and central memory phenotype. The study is ongoing, with additional patients due to be treated to define the recommended Phase 2 dose.