Autolus Therapeutics Receives European Marketing Authorization for Aucatzyl in Adult Patients

Autolus Therapeutics has received European Marketing Authorization for its CAR T therapy Aucatzyl (obecabtagene autoleucel) for adult patients. Aucatzyl is a treatment for certain types of non-Hodgkin's lymphoma and has been shown to be effective in clinical trials. The authorization marks a significant milestone for Autolus Therapeutics and its efforts to bring new treatments to patients with cancer.

Autolus Therapeutics plc (Nasdaq: AUTL), a leading biopharmaceutical company, has received significant regulatory approval for its innovative CAR T therapy, AUCATZYL® (obecabtagene autoleucel or “obe-cel”). The European Commission (EC) has granted marketing authorization for AUCATZYL® for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [1].

The EC approval is based on the results of the FELIX clinical trial, an open-label, multi-center, single-arm study that enrolled adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia. The pivotal cohort of patients (cohort IIA, n=94) demonstrated a high and durable response rate, with 76.6% achieving Complete Response/Complete Response with Incomplete Haematological Recovery (CR/CRi) after at least one infusion of obecabtagene autoleucel. The median response duration for all infused patients was 21.2 months, and the estimated 6- and 12-month event-free survival rates were 65.4% and 49.5%, respectively [1].

The most common adverse reactions observed were infections-pathogen unspecified (32%), febrile neutropenia (24%), and bacterial infectious disorders (11%). Cytokine release syndrome (CRS) developed in 68.5% of patients, with events of grade 3 or higher in 2.4%, and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) developed in 22.8% of patients, with grade 3 or higher occurring in 7% [1].

Dr. Christian Itin, Chief Executive Officer of Autolus, stated, "We believe AUCATZYL represents an important new treatment option for physicians treating adult r/r B-ALL patients. With the EU marketing authorization, we are now evaluating market entry opportunities in EU countries." This approval follows positive opinions from the CHMP, MHRA conditional marketing authorization, and FDA approval, further underscoring the potential of AUCATZYL® in treating this aggressive form of blood cancer [1].

AUCATZYL® is an autologous CD19 CAR T cell therapy with a proprietary CD19 CAR, designed to mimic physiological T-cell receptor interactions. The therapy is part of Autolus’ pipeline of next-generation T cell therapies for the treatment of cancer and autoimmune diseases. The company’s mission is to develop precisely targeted and controlled T cell therapies that better recognize and eliminate target cells [2].

In Europe, there are approximately 6,000 new cases of ALL diagnosed each year, with up to 50% of adult B-ALL patients ultimately relapsing, and survival rates remaining very poor with conventional treatments. The EC approval applies to all 27 European Union Member States, Iceland, Norway, and Liechtenstein, expanding access to this potentially life-saving treatment [1].

References:
[1] https://finance.yahoo.com/news/autolus-therapeutics-car-t-therapy-110000288.html
[2] https://www.autolus.com