MedPath

Lisocabtagene maraleucel

Generic Name
Lisocabtagene maraleucel
Brand Names
Breyanzi
Drug Type
Biotech
Chemical Formula
-
CAS Number
-
Unique Ingredient Identifier
7K2YOJ14X0
Background

Lisocabtagene maraleucel is a chimeric antigen receptor (CAR) T-cell therapy, similar to brexucabtagene autoleucel and axicabtagene ciloleucel. Lisocabtagene maraleucel is a genetically modified autologous T-cell therapy that targets CD19, the B-lymphocyte surface antigen B4.

CAR T-cell therapy has changed the treatment of B-cell lymphomas, significantly increasing survival rates over standard therapy. However, data on the efficacy of CAR T-cell therapies on less severe forms of B-cell lymphoma are lacking. Despite the adverse reactions, the majority of patients given lisocabtagene maraleucel reported an overall increase in quality of life over a 1 year period.

Lisocabtagene maraleucel was granted FDA approval on 5 February 2021 and EC approval on 5 April 2022. It was later granted Health Canada approval on 6 May 2022.

Indication

Lisocabtagene maraleucel is indicated to treat adults with relapsed or refractory large B-cell lymphoma after ≥2 systemic therapies, diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma.

Associated Conditions
Grade 3b Follicular Lymphoma, High-grade B Cell Lymphoma (HGBCL), Primary Mediastinal (Thymic) Large B Cell Lymphoma (PMBCL), Refractory Diffuse Large B Cell Lymphoma (DLBCL), Refractory Large B-cell Lymphoma, Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
Associated Therapies
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AstraZeneca set to take a BiTE out of follicular lymphoma market

AstraZeneca presented interim results of AZD0486, a CD19xCD3 BiTE, at ASH 2024, showing 96% ORR and 85% CR in r/r FL patients. AZD0486's CRS rate of 45% with all grade 1 events compares favorably to Epkinly and similarly to Lunsumio. A phase II trial is underway, with potential for first-in-class approval and $158 million in global sales by 2030.
onclive.com
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Liso-Cel Shows Broad Spectrum Activity in CIBMTR Cohort of Relapsed/Refractory LBCL

Real-world data on liso-cel (Breyanzi) in relapsed/refractory large B-cell lymphoma (LBCL) showed safety and efficacy comparable to pivotal trials, with median progression-free survival (PFS) and overall survival (OS) not reached (NR) at 6.4 months follow-up. Objective response rate (ORR) was 84% with a complete response (CR) rate of 70%, and median duration of response (DOR) was NR. These results support liso-cel as a second-line standard-of-care treatment for LBCL.
cancernetwork.com
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Positive Efficacy and Safety Outcomes Result from Second-line Liso-cel in LBCL

Liso-cel therapy in relapsed/refractory large B-cell lymphoma showed consistent PFS and OS with prior trials, with median PFS and OS not reached at 6.4 months follow-up. ORR was 84% with a CR rate of 70%, and median DOR was NR. Safety profile consistent with previous reports, with most patients experiencing low-grade CRS and ICANS.
openpr.com
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CAR T-Cell Therapy for Non-Hodgkin's lymphoma Pipeline

DelveInsight's 2024 report on CAR T-Cell Therapy for Non-Hodgkin's lymphoma highlights 5+ companies developing 5+ therapies, including JCAR017, CB010, and BREYANZI. The report covers clinical trials, mechanisms of action, route of administration, and market dynamics, emphasizing Novartis's Rapcabtagene autoleucel and its reduced turnaround time.
benzinga.com
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Bristol-Myers Faces Renewed $6.7 Billion Lawsuit Over Drug Approval Delays Amid ...

Judge Jesse Furman dismissed a $6.4 billion lawsuit against Bristol-Myers Squibb, as UMB Bank lacked proper trustee appointment. UMB Bank resolved the issue, now confirmed as trustee, allowing a new $6.7 billion lawsuit to proceed, alleging Bristol Myers delayed drug approvals to avoid payments to former Celgene shareholders.
onclive.com
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Piecing Together the Proper BTK Usage in CLL

Nicole Lamanna discussed the progression in CLL patients with covalent BTK inhibitors and venetoclax, emphasizing the need for new treatments. She highlighted clinical trials and CAR T-cell therapy options, including the TRANSCEND CLL 004 trial with lisocabtagene ciloleucel, and the CaDAnCE-101 trial with BGB-16673. Lamanna also presented the EPCOR trial with epcoritamab-bysp, suggesting bispecific antibodies as potential next steps for CLL treatment.
pharmaphorum.com
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Autolus bags FDA approval for leukaemia cell therapy

Autolus secures FDA approval for Aucatzyl, a CD19-targeting CAR-T therapy for relapsed or refractory B-cell precursor ALL, with no REMS requirement. Aucatzyl achieved 42% complete remission in the FELIX trial, with low rates of CRS and neurotoxicity. Competing with Novartis' Kymriah and Gilead/Kite's Tecartus, Aucatzyl aims to capture market share in the US, targeting around 3,000 patients.
morningstar.com
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Bristol Myers's stock pops as earnings top estimates and company raises guidance

Bristol-Myers Squibb's stock rose 2.9% after Q3 earnings beat expectations, with revenue up 8% to $11.892B. The company raised full-year guidance, expecting EPS of 75-95 cents and revenue growth of 5%. Eliquis sales rose 11% to $3B, while newer products saw a 18% increase to $5.812B. Opdivo sales were up 4% to $2.36B.
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