Bridging the Gap: Expanding Access and Optimizing Outcomes with Breyanzi (Lisocabtagene Maraleucel)
Recent discussions at the 2026 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR highlight a critical need to address disparities in outcomes for patients receiving lisocabtagene maraleucel (liso-cel; Breyanzi) outside of clinical trial settings. While efficacy appears consistent between trial participants and real-world patients, ensuring equitable access and maximizing benefit for all remains a key challenge.
Real-World vs. Clinical Trial: Identifying the Discrepancies
Dr. Irtiza N. Sheikh of The University of Texas MD Anderson Cancer Center emphasized the importance of understanding why patients treated in community settings often receive Breyanzi later in their treatment course. Data presented suggests real-world patients typically undergo one more line of prior systemic therapy compared to those enrolled in clinical trials (three lines versus two).
This delay in access could be linked to several factors. Institutions primarily utilizing Breyanzi within clinical trials may have different patient characteristics or treatment protocols. Further research is needed to pinpoint these differences and understand how they impact outcomes.
The Impact of Comorbidities and Refractory Disease
Comorbidities also appear to play a role. A significant proportion of patients in real-world settings – at least half, according to presented data – have multiple comorbidities. The impact of these pre-existing conditions on Breyanzi’s effectiveness and safety requires further investigation, particularly as clinical trial data may not fully represent this patient population.
The prevalence of chemotherapy-refractory disease in the outpatient setting is another area of concern. Understanding how Breyanzi performs in patients who have already failed multiple chemotherapy regimens is crucial for optimizing treatment strategies.
Expanding Access and Proactive Use of Breyanzi
A central theme emerging from these discussions is the need to broaden access to Breyanzi beyond specialized centers. Dr. Sheikh advocates for increased comfort among clinicians in utilizing the therapy earlier in the treatment pathway, even for patients with multiple comorbidities or those who have been heavily pretreated.
This requires effective communication and education to dispel any hesitation about using Breyanzi in diverse patient populations. The data suggests the therapy remains safe and effective in these groups, challenging the notion that it should be reserved for only the fittest candidates.
Breyanzi: A Growing Role in Lymphoma Treatment
Breyanzi is a CD19-directed genetically modified autologous T cell immunotherapy approved for several types of large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, and others. It’s also approved for certain cases of chronic lymphocytic leukemia (CLL) and modest lymphocytic lymphoma (SLL), and more recently, for relapsed or refractory marginal zone lymphoma (MZL) as of December 2025. The therapy involves modifying a patient’s own T cells to recognize and attack cancer cells.
Did you know? Breyanzi is not indicated for patients with primary central nervous system lymphoma.
Future Research Directions
Several key questions remain for future research:
- Are there systematic differences in clinical characteristics between institutions offering Breyanzi in trial versus standard-of-care settings?
- What is the impact of delaying Breyanzi treatment, and how can we encourage earlier utilization?
- How does the presence of chemotherapy-refractory disease affect outcomes in the outpatient setting?
- What is the prevalence of comorbidities among patients enrolled in clinical trials compared to those treated in real-world settings?
FAQ
Q: What is Breyanzi used to treat?
A: Breyanzi is used to treat certain types of large B-cell lymphoma, CLL, SLL, follicular lymphoma, and marginal zone lymphoma.
Q: What are the potential side effects of Breyanzi?
A: Potential side effects include hypersensitivity reactions, serious infections, low blood cell counts, and a weakened immune system.
Q: Is Breyanzi available at all cancer centers?
A: Currently, access to Breyanzi may be limited to specialized centers. Efforts are underway to expand access to more community-based settings.
Q: What is CAR-T therapy?
A: CAR-T therapy, like Breyanzi, is a type of immunotherapy that involves modifying a patient’s own T cells to fight cancer.
Pro Tip: Patients considering Breyanzi should discuss the potential benefits and risks with their oncologist to determine if it’s the right treatment option for their specific situation.
Stay informed about the latest advancements in lymphoma treatment. Visit the official Breyanzi website for more information and resources. You can also learn more about CAR-T therapy from the FDA website.
What are your thoughts on expanding access to innovative cancer therapies like Breyanzi? Share your perspective in the comments below!
