Autolus Therapeutics plc (Nasdaq: AUTL) is moving forward with the commercial launch of AUCATZYL® (obecabtagene autoleucel, or "obe-cel") in the United States following its FDA approval on November 8, 2024, for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The company anticipates potential marketing approvals from the MHRA and EMA in the second half of 2025.
As of January 10, 2025, 24 treatment centers are fully authorized, and Autolus expects to complete authorization of the first 30 treatment centers by the end of January 2025, covering approximately 60% of the identified target patient population. The company aims to authorize 60 treatment centers, covering approximately 90% of the target patient population, by the end of 2025.
NCCN Guidelines Inclusion
In December 2024, the National Comprehensive Cancer Network® (NCCN) added AUCATZYL® to its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the treatment of adult patients with r/r B-ALL. This inclusion further validates the clinical benefit, favorable safety profile, and potential impact of AUCATZYL® for patients in need, particularly noting the absence of a Risk Evaluation and Mitigation Strategy (REMS) program, unlike some other CAR-T therapies.
Clinical Development and Expansion
Autolus is also planning to expand its clinical development programs, including exploring the potential of obe-cel in autoimmune diseases. Initial data from the ongoing CARLYSLE Phase 1 trial in systemic lupus erythematosus (SLE) are expected in Q1 2025, with a full data presentation targeted for the second half of 2025 at a medical conference. An R&D investor event is scheduled for April 23, 2025, in New York City, where the company will provide updates on these initiatives.
About AUCATZYL
AUCATZYL® is a CD19-directed genetically modified autologous T cell immunotherapy. It is designed with a fast target binding off-rate to minimize excessive activation of programmed T cells, potentially improving both efficacy and safety. The approval was based on the FELIX trial, which demonstrated a high overall response rate and favorable tolerability profile, even in a challenging patient population.
Safety Profile
The safety profile of AUCATZYL® includes warnings for Cytokine Release Syndrome (CRS), neurologic toxicities, and secondary hematological malignancies. In the FELIX trial, CRS was reported in 75% of patients, with Grade 3 CRS occurring in 3%. Neurologic toxicities were observed in 64% of patients, including Grade ≥ 3 in 12%.
