New CAR T-cell Therapy FDA-Approved for B-cell ALL

If you are an adult with relapsed/refractory precursor B-cell ALL, learn how a new FDA-approved CAR T-cell therapy may be a treatment option for you. 

What is the CAR T-cell Therapy Obe-cel? 

Obe-cel, short for obecabtagene autoleucel (Aucatzyl by Autolus Inc.), is a CAR T-cell therapy that was recently FDA-approved on November 8th, 2024, for adults with relapsed/refractory precursor B-cell acute lymphoblastic leukemia, the most common subtype of ALL.  

Relapsed/refractory refers to the cancer that came back after or stopped responding to a prior treatment. To qualify to receive obe-cel, relapsed/refractory qualifications specifically include: 

• Relapsed after remission of 12 months or less
• Relapsed/refractory ALL after two or more lines of systemic therapy
• Relapsed/refractory ALL three months or more after an allogeneic stem cell transplant 

Obe-cel works by enhancing patients' cancer-killing T-cells to attach to the surface protein CD19 on ALL cells. Over 90% of B-cell ALL patients have the CD19 protein on the surface of cancer cells, meaning they may be able to receive obe-cel. 

The treatment is administered in two separate infusions. The first infusion is given on day one of therapy and the second on day 10. 

How Effective is Obe-cel for Precursor B-cell ALL? 

Topline data from the FELIX study announced in the FDA’s press release stated that three months after treatment was finished, 42% of B-cell ALL patients achieved a complete reduction in cancer signs/symptoms. Since achieving a response, patients continued to remain in remission for an average of 14.1 months. 

“Adult ALL is an extremely aggressive cancer, and there is a high unmet medical need that exists in the treatment of patients with this disease once they relapse, where historically they suffer from poor outcomes. This milestone approval, based on the demonstrated clinical benefit of AUCATZYL, brings new hope for adult patients with relapsed/refractory B-ALL.” -Elias Jabbour, MD, U.S. lead investigator of the FELIX study and professor of Leukemia, ALL Section Chief, at The University of Texas MD Anderson Cancer Center, Houston, Texas.

What are the Possible Side Effects of Obe-cel? 

After receiving obe-cel, the most common side effects patients experienced were cytokine release syndrome (CRS) and brain-related side effects. Other noted side effects included infections, muscle/joint pain, fever, nausea, diarrhea, high blood pressure, headache, and hemorrhage. 

If you have concerns about how treatment-related side effects are reduced, ask your ALL specialist about side effect management strategies. 

You are also welcome to visit HealthTree’s Side Effect Solutions tool, which was contributed by other blood cancer patients. Feel free to add any side effect management strategies you have found helpful! However, make sure to talk to your doctor before making any significant changes or implementing any of the side-effect solutions.  

Why Would Obe-cel Not Work? 

Possible reasons the CAR T-cell therapy obe-cel may not work could include reasons like: 

• The CAR T-cells become exhausted as a result of high oxidative stress impacting their mitochondria. Click here to learn more. 
• The cancer cells may mutate, changing the membrane protein that CAR T-cells need to bind to. 

Summary

Obe-cel is a recently FDA-approved CAR T-cell therapy for adults with relapsed/refractory precursor B-cell acute lymphoblastic leukemia (ALL). The two infusions helped 42% of patients achieve a full reduction of ALL signs/symptoms three months after treatment. These patients continued to remain in remission for an average of 14 months since achieving a response. 

Common side effects of obe-cel included cytokine release syndrome and brain-related effects. If you have concerns about how CAR T-cell therapy side effects are managed, please reach out to your ALL specialist. Obe-cel represents a significant advancement in the management of this aggressive cancer. 

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Sources: 

• FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia
• Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
• CD19 in B-cell ALL