On June 2, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the presentation of top-line data from the Pivotal Phase 2 FELIX study of obe-cel in adult r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Autolus, JUN 2, 2023, View Source [SID1234632402]).

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In the pivotal morphological cohort of the FELIX trial, 112 patients with r/r adult ALL were enrolled and 94 (84%) patients were dosed with obe-cel. Of the dosed patients, 76% patients achieved a complete response (CR) or CR with incomplete haematological recovery (CRi), and 97% of the responders with evaluable samples were in deep remission with no detectable minimal residual disease (MRD). Furthermore, at a 9.5-month median follow up, 61% of responders remained in ongoing remission without new anti-cancer therapies. CAR T cellular kinetics demonstrate excellent CAR T engraftment and persistence and are consistent with the prior ALLCAR19 study.

Safety analysis demonstrated a potentially best-in-class tolerability profile with Grade ≥3 cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in 3% (3/94) and 7% (7/94) of patients, respectively. Most of the toxicity was seen in patients with high disease burden. Notably, 6 of 7 Grade ≥3 ICANS were observed among patients with very high tumor burden of more than 75% bone marrow blasts at lymphodepletion. Overall, Grade ≥3 adverse events occurred in 79% of patients, with neutropenia (36.2%), and thrombocytopenia (25.5%) most commonly reported.

Manufacturing was reliable and consistent, with product released for 94% of leukapheresed patients and median turnaround times of 21 days from vein to release.

"We are very encouraged by the outcome of the FELIX study. Obe-cel shows low immunotoxicity, high complete remission rates and excellent CAR T expansion and persistence in adult B-ALL. These data are consistent with the prior ALLCAR19 study and suggest that obe-cel has the potential for long-term clinical benefit in adult B-ALL patients without additional therapies," said Dr. Claire Roddie, Associate Professor at UCL, Honorary Consultant Haematologist at UCLH.

"We are pleased that our pivotal FELIX study confirms the attractive product profile for obe-cel, combining a high level of clinical activity with an excellent safety profile which we know is critical for this highly pre-treated and frail patient population. Conducting this study through the pandemic was a pressure test for obe-cel’s product profile and our ability to deliver obe-cel reliably under difficult circumstances. We would like to thank patients, their care givers, nurses and treating physicians for their participation in the FELIX study," said Dr. Christian Itin, Chief Executive Officer of Autolus.

"With the Nucleus, our commercial manufacturing facility, well advanced in validation we look forward to submitting a BLA towards the end of this year and working with the FDA to get obe-cel to patients as soon as possible."

ASCO Oral Presentation, abstract #7000:

Title: Safety and efficacy of Obecabtagene autoleucel (obe-cel, AUTO1), a fast-off rate CD19 CAR in relapsed/refractory adult B-Cell acute lymphoblastic leukemia (r/r B-ALL): Topline results of the pivotal FELIX study

Session Title: Hematologic Malignancies — Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session date and time: Friday, June 2, 2023, 2.00 pm –2.12 pm ET, 7.00 pm – 7.12 pm BST
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Consultant Haematologist and Honorary Senior Lecturer, Cancer Institute, University College London (UCL)

Additional data from the FELIX study will be presented as an Oral Presentation at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) meeting:

Title: Safety and efficacy of Obecabtagene autoleucel (obe-cel, AUTO1), a fast-off rate CD19 CAR in relapsed/refractory adult B-Cell acute lymphoblastic leukemia (r/r B-ALL): Topline results of the pivotal FELIX study

Presentation ID: S262
Session date and time:
Saturday, June 10, 2023, 11.00 am – 11.15 am ET, 4.00 pm – 4.15 pm BST
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Consultant Haematologist and Honorary Senior Lecturer, Cancer Institute, University College London (UCL)

Conference Call

Autolus will host a conference call and webcast today for analysts at 4.00 pm ET/9.00 pm BST to summarize the ASCO (Free ASCO Whitepaper) data. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call.

A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.