Autolus Therapeutics Presents Positive Data on Obe-cel in B-cell ALL

Autolus Therapeutics PLC presented longer-term follow-up and additional data analysis from the pivotal phase 1b/2 Felix study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell acute lymphoblastic leukemia (ALL) at the 2024 American Society of Clinical Oncology (ASCO) annual meeting. The majority of ongoing responders showed durable responses, with 40% of patients in ongoing remission without subsequent stem cell transplant (SCT) or other therapy. At a median follow-up of 21.45 months, the overall response rate (CR/CRI) in all patients who received obe-cel in the Felix study was 78% (99/127 patients).

Furthermore, the median event-free survival (EFS) was 11.9 months, and the median overall survival (OS) was 23.8 months, with estimated 12-month EFS and OS rates of 49.5% and 61.1%, respectively. Notably, 18% of responders had SCT while in minimal residual disease (MRD)-negative remission, and 40% of responders were in ongoing remission without subsequent SCT or other therapy.

Additionally, it was observed that ongoing CAR T cell persistence was associated with improved event-free survival, while consolidative SCT for patients post-obe-cel did not appear to improve EFS or OS. Patients with loss of CAR T persistence had a 2.7 fold increased risk of relapse or death compared to patients with ongoing CAR T persistence.

The results of the Felix trial have been submitted to the FDA as part of a Biologics License Application (BLA), with the PDUFA target action date set for November 16, 2024.

Following these announcements, the company's shares moved -7.4%, and are now trading at a price of $4.17. If you want to know more, read the company's complete 8-K report here.

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