Lisocabtagene maraleucel is a Gene-Modified Cell Therapy owned by Bristol-Myers Squibb, and is involved in 16 clinical trials, of which 2 were completed, 12 are ongoing, and 2 are planned.

Lisocabtagene maraleucel (JCAR-017) elicit anti-neoplastic activity. Patient's own T cells are extracted and genetically modified to expresses a chimeric antigen receptor (CAR). JCAR017 is directed to and induce selective toxicity in CD19-expressing tumor cells. CD19 antigen is a B-cell specific cell surface antigen expressed in all B-cell lineage malignancies. Devoid of both ligand binding domains and tyrosine kinase activity, the expressed EGFRt both facilitates in vivo detection of the administered, transduced T cells and promote elimination of those cells through a antibody dependent cellular cytotoxicity (ADCC) response. The 4-1BB costimulatory signaling domain that enhances both proliferation of T cells and antitumor activity.

The revenue for Lisocabtagene maraleucel is expected to reach a total of $28.9bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Lisocabtagene maraleucel NPV Report.

Lisocabtagene maraleucel was originated by Seattle Children’s Hospital and is currently owned by Bristol-Myers Squibb.

Lisocabtagene maraleucel Overview

Lisocabtagene maraleucel (Breyanzi) is a CD19-directed genetically modified autologous T cell immunotherapy administered as a defined composition of chimeric antigen receptor (CAR) -positive viable T cells. It is formulated as suspension for intravenous route of administration. Breyanzi is indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Breyanzi is indicated for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy. 

Lisocabtagene maraleucel (JCAR-017) is under development for the treatment of as a second and third line therapy for B-cell non-Hodgkin lymphoma includes diffuse large b-cell lymphoma (DLBCL) nos [de novo or transformed follicular lymphoma (TFL)], double/triple-hit lymphoma [DHL/THL], follicular lymphoma grade 3b [FL3B], 1L high grade B-cell lymphoma, primary central nervous system lymphoma [PCNSL] and Richter's transformation, acute lymphoblastic leukemia (ALL) and relapsed or refractory indolent lymphoma, primary mediastinal B-cell lymphoma, relapsed and refractory chronic lymphocytic leukemia, follicular lymphoma and mantle cell lymphoma. It is administered intravenously. The therapeutic candidate comprises of isolated T cells transduced with a lentivirus expressing CAR (chimeric antigen receptor) containing an anti-CD19 single chain variable fragment (scFv) fused to the signaling domain of 4-1BB (CD137), the zeta chain of the TCR/CD3 complex (CD3-zeta), and a truncated form of the human epidermal growth factor receptor (EGFRt).

Bristol-Myers Squibb Overview

Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in New York City, New York, the US.

The company reported revenues of (US Dollars) US$46,385 million for the fiscal year ended December 2021 (FY2021), an increase of 9.1% over FY2020. The operating profit of the company was US$8,615 million in FY2021, compared to an operating loss of US$6,847 million in FY2020. The net profit of the company was US$6,994 million in FY2021, compared to a net loss of US$9,015 million in FY2020. The company reported revenues of US$11,218 million for the third quarter ended September 2022, a decrease of 5.6% over the previous quarter.

Quick View – Lisocabtagene maraleucel

Report Segments
  • Innovator (NME)
Drug Name
  • Lisocabtagene maraleucel
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.