Brexucabtagene Autoleucel for Relapsed/Refractory ALL

Brexucabtagene autoleucel (Tecartus), also known as brexu-cel, is a chimeric antigen receptor (CAR) T-cell therapy designed to target CD19-positive leukemia cells. It is approved for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) and relapsed or refractory mantle cell lymphoma (MCL).  While this treatment has shown good results for younger patients, data on its safety and efficacy in older people remains limited. 

In this article, we’ll dive into the results presented at the 66th annual ASH conference. The study, conducted through the Real-World Outcomes Collaborative for CAR-T in Acute Lymphoblastic Leukemia (ROCCA), is the largest to date evaluating brexu-cel in patients aged 60 years or older. 

Study Details

280 patients participated and received brexu-cel, and 26% were 60 or older. They had undergone a median of three prior lines of therapy, including:

• Allogeneic hematopoietic stem cell transplantation: 38%
• Inotuzumab ozogamicin (BESPONSA): 41%
• Blinatumomab (Blincyto): 62%

Treatment Response

Before receiving brexu-cel, 45% of patients had active disease, 47% were in complete remission, of whom 14 showed no measurable residual disease.

After receiving brexu-cel, 59% of patients achieved MRD-negative complete remission, and 27% had complete remission with detectable disease.

Brexu-cel Benefited Patients of All Age Groups

The overall response rate was consistent across age groups. For instance, the MRD (measurable residual disease)-negative complete remission was 58% in patients aged 60-69 and 61% in patients aged 70 years or older. These results are comparable to those registered in patients younger than 60 years, with a measurable residual disease-negative complete remission rate of 66% and a refractory disease rate of 9%.

No significant differences were observed in overall survival or progression-free survival at 6 months between age groups.

Side Effects of Brexucabtagene Autoleucel by Age

Immune effector cell-associated neurotoxicity syndrome (ICANS) was more frequent in patients aged 70 years or older (77%) compared to 60-69 years (47%) and younger than 60 years (49%). And cytokine release syndrome rates were comparable across all groups.

Conclusion and Future Directions

This study represents the largest real-world analysis of brexu-cel treatment in older adults with relapsed or refractory B-cell acute lymphoblastic leukemia. The results suggest that patients aged 60-69 years have comparable outcomes to younger patients, while those aged 70 years or older might have a shorter progression-free survival and higher rates of low-grade immune effector cell-associated neurotoxicity syndrome. 

This study also found important insights to consider when evaluating treatment response. Also, future studies should include patients aged 70 years or older (considering their health status and previous treatments as for all patients) and the need for further research to optimize CAR-T cell therapy strategies for older adults, ensuring both safety and effectiveness.

Age is no longer a limiting factor in most current therapies. By understanding the unique challenges and potential benefits of CAR-T, all options should be discussed and considered with your medical team, considering not only chronological age but biological age and real patient fitness.

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Source: 

• Efficacy and Safety of Brexucabtagene Autoleucel for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in Patients Aged 60 and Above