Autolus Therapeutics (AUTL) Status Update summary

FELIX study results and clinical insights

• Updated data from the pivotal FELIX study of obe-cel in adult relapsed/refractory B-cell ALL show 40% of responders remain in remission at a median 21.5 months follow-up, without need for subsequent transplant or other therapies.

• Event-free survival (EFS) and overall survival (OS) curves suggest a long-term plateau, indicating potential for durable remissions similar to pediatric CAR T studies.

• Consolidation with stem cell transplant after obe-cel did not improve EFS or OS; most patients who underwent transplant relapsed or died, likely due to loss of CAR T persistence from conditioning therapy.

• Ongoing CAR T-cell persistence is strongly associated with improved EFS, with loss of persistence increasing relapse or death risk by 2.7x.

• Safety profile remains favorable, with low rates of high-grade cytokine release syndrome (2%) and ICANS (7%), even in high tumor burden patients.

Practice implications and physician feedback

• Data are considered practice-changing, with broad excitement among clinicians due to ease of administration and favorable safety, making obe-cel suitable for older and comorbid patients.

• Watch-and-wait is favored over routine transplant consolidation, especially in patients with ongoing CAR T persistence and low disease burden.

• CAR T persistence and MRD monitoring are expected to guide future consolidation decisions, with systematic evaluation of these parameters underway.

• No clear use case for TECARTUS over obe-cel was identified by leading clinicians.

Commercial and regulatory update

• U.S. regulatory review is ongoing with a PDUFA target date of November 16; European and UK filings are in progress.

• Commercial launch preparations include 30-36 U.S. centers ready at approval, expanding to 60 within the first year, aiming to reach 90% of eligible patients.

• New manufacturing facility in the UK is licensed and ready for production.

• NTAP reimbursement application is planned post-approval to support treatment centers.