Obe-cel

Developing a transformational treatment for adult Acute Lymphoblastic Leukemia

The novel fast off rate CAR in obe-cel drives T cell activity and long-term persistence in the absence of severe immunotoxicity

Adult Acute Lymphoblastic Leukemia

Adult B-ALL (acute lymphoblastic leukemia) is an aggressive type of leukemia characterised by the presence of too many B lymphocytes in the bone marrow and peripheral blood. Without treatment adult ALL usually progresses very rapidly. Prognosis for patients based on current treatments is very poor. 

Combination chemotherapy enables 90% of adult patients to enter complete remission, but only 30-40% of these patients will achieve long term remission. The median overall survival is < 1 year in r/r adult ALL.

The only redirected T cell therapies for adult patients are blinatumomab and brexucabtagene autoleucel. These therapies are highly active, but achieving long term remissions remains challenging. Patients are generally more fragile with co-morbidities, yet CAR T toxicities in this setting have been notable with high incidences of severe CRS and cases of fatal neurotoxicity.

A significant unmet need remains for adult ALL patients. A successful therapy requires high level of activity and sustained persistence paired with good tolerability.

Adult ALL is a significant unmet medical need

8,400 patients*

New cases of adult ALL diagnosed every year in the US and EU

 

3,000 patients* 

Estimated addressable adult ALL patients in relapsed refractory setting

 

*SEER and EUCAN estimates (respectively) for US and EU

Median OS <1 year

Median overall survival <1 year for relapsed refractory adult ALL

Obe-cel in adult ALL

Data from the FELIX Phase 1b and ALLCAR19 Phase 1 studies in relapsed / refractory adult ALL patients shows a high levels of complete responses across both studies in the absence of high grade (≥Grade 3) cytokine release syndrome (CRS) and with low rates of immune effector cell-associated neurotoxicity syndrome (ICANS). 

In the ALLCAR19 study where longer term follow up data is available, we continue to observe sustained responses with obe-cel without the requirement for subsequent therapy. The event free survival, a measure of long term efficacy, is 46% at 24 months, with some patients approaching up to 42 months of durability. These data support the curative potential of obe-cel as a standalone therapy in r/r adult ALL patients.

Obe-cel, is currently being trialed in the potentially pivotal FELIX study for adult ALL. In this indication, obe-cel has been granted orphan drug designation by the FDA, PRIME designation by EMA and ILAP designation by the MHRA. Autolus expects to present data from the Phase 2 portion of the FELIX study in 2022.

Latest Obe-cel Abstracts and Publications

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American Society of Hematology Annual Meeting
December 13 2021

Safety and Efficacy of AUTO1, a Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL) and Chronic Lymphocytic Leukaemia (CLL)

American Society of Hematology Annual Meeting
December 12 2021

Industrialization of an Academic Miltenyi Prodigy-Based CAR T process

Journal of Clinical Oncology
August 04 2021

Durable responses and low toxicity after fast off-rate CD19 CAR-T therapy in adults with relapsed/ refractory B-ALL