Real World Outcomes of Liso-cel for Large B-cell Lymphoma

How effective is the CAR T-cell therapy liso-cel (Breyanzi, BMS) for people with relapsed/refractory large B-cell lymphoma (LBCL) in the real world? 

Maria Silvina Odstrcil Bobillo, MD, a fellow from the University of Utah School of Medicine, led research to assess this question, and the findings were showcased at the 2024 ASH conference. Understanding how treatments perform outside of clinical trials is crucial, as it helps establish expectations based on what happens in the real world, which often differ from the controlled conditions of clinical trials. 

Liso-cel’s Impact in the Real World for LBCL 

Dr. Bobillo and colleagues reviewed the medical records of 157 LBCL patients who received liso-cel as their second treatment between June 2022 and August 2024. These patients, averaging 72 years of age, primarily had prior treatment with R-CHOP. Notably, over 67% of them would not have qualified for the TRANSFORM clinical trial—liso-cel's pivotal study—due to age or pre-existing health issues such as heart, lung, or obesity concerns.

At an average follow-up of 6.4 months after the liso-cel infusion:

Side Effects

The majority of patients encountered only mild to moderate side effect versions of cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), prolonged cytopenia (low blood counts), or infections. Patients over 70 did experience higher rates of ICANS. 

Special Considerations for CNS-Affected Patients

Parallel research by Sairah Ahmed, MD, of MD Anderson Cancer Center, focused on relapsed/refractory LBCL patients with secondary central nervous system (sCNS) involvement. The outcomes of liso-cel for these patients were promising, mirroring those of the broader group in the TRANSCEND trial, with manageable side effects similar to those without sCNS involvement. 

These findings are particularly important given that LBCL patients with sCNS involvement have historically faced poor outcomes when treated with chemotherapy. Highlighting that liso-cel is both effective and safe for these patients represents a significant breakthrough, offering hope for those dealing with this challenging condition. 

Conclusion

In the real world, liso-cel has helped the majority of patients achieve meaningful responses, even though many would not have qualified for the TRANSFORM clinical trial due to their age or other health conditions. This evidence supports the use of liso-cel as a standard second-line treatment for individuals with relapsed/refractory LBCL. Further research into liso-cel’s effectiveness for LBCL patients with secondary central nervous system (sCNS) involvement has also demonstrated that it is a safe and effective option for this particularly high-risk group.

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Sources: 

• Real-World (RW) Outcomes of Lisocabtagene Maraleucel (liso-cel) As Second-Line (2L) Therapy in Patients (pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL): First Results from the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry
• Real-World (RW) Outcomes of Lisocabtagene Maraleucel (liso-cel) in Patients (pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) and Secondary Central Nervous System (sCNS) Involvement from the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry
• 626. Aggressive Lymphomas: Clinical and Epidemiological: CARs, Bispecifics, and ADCs: Progress and Challenges in Aggressive B Cell Lymphoma