Legend Biotech Announces ASH 2020 Data Presentations for Ciltacabtagene Autoleucel (cilta-cel), an Investigational BCMA CAR-T Cell Therapy in Development for Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM)
- New Results from Phase 1b/2 CARTITUDE-1 Study of BCMA-directed CAR-T Cell Therapy Cilta-cel in Treatment of Patients with RRMM to be Featured in Oral Presentation
CARTITUDE-1 data for oral presentation will highlight Phase 1b/2 efficacy and safety results for the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel). Additional poster presentations for cilta-cel data will include detailed analyses of cytokine release syndrome and health-related quality of life outcomes from CARTITUDE-1. LEGEND-2 data in patients with relapsed or refractory multiple myeloma and extramedullary disease will also be presented as a poster.
“We look forward to sharing new data from the CARTITUDE-1 study in the US and the LEGEND-2 study in China,” said
On
Following are details of the five abstracts that have been accepted for presentation at the 62nd ASH Annual Meeting & Exposition. For additional information visit: https://www.hematology.org/meetings/annual-meeting/schedule-and-program.
Abstract No. |
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Date/Time |
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Oral Presentation |
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Abstract #177 |
CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma |
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Poster Presentations |
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Abstract #1412 |
Patient Expectations and Perceptions of Treatment in CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma |
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Abstract #2291 |
Health-Related Quality of Life in the CARTITUDE-1 Study of Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma |
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Abstract #2304 |
Chimeric Antigen Receptor T Cell Therapy in the Relapsed or Refractory Multiple Myeloma with Extramedullary Disease--a Single Institution Observation in |
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Abstract #3240 |
Cytokine Release Syndrome in Patients With Relapsed/Refractory Multiple Myeloma Treated With Ciltacabtagene Autoleucel in the Phase 1b/2 CARTITUDE-1 Study |
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About CARTITUDE-1
Cilta-cel is currently being investigated in the Phase 1b/2 CARTITUDE-1 (MMY2001, NCT03548207) registration study conducted in the US and
About LEGEND-2
LEGEND-2 (NCT03090659) is an ongoing single-arm, open-label Phase 1 study of 74 patients being conducted at four participating hospitals in
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.3 Although treatment may result in remission, unfortunately, patients will most likely relapse.4 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.5 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.6,7 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.8 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.9
About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the
In addition to a Breakthrough Therapy Designation (BTD) granted in the
About
We are engaged in a strategic collaboration with
To learn more about
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s clinical efforts, its partnership with Janssen, and the data relating to CARTITUDE-1 and LEGEND-2 studies. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the “Risk Factors” section of the prospectus filed with the
References
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CARTITUDE-1 (NCT03548207). Available: https://clinicaltrials.gov/ct2/show/NCT03548207. Accessed
November 2020 . -
LEGEND-2 (NCT03090659). Available: https://clinicaltrials.gov/ct2/show/NCT03090659. Accessed
November 2020 . -
American Society of Clinical Oncology . Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction . AccessedNovember 2020 . - Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–2207.
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National Cancer Institute . NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866. AccessedNovember 2020 . -
National Cancer Institute . NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245. AccessedNovember 2020 . - Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.
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American Cancer Society . Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. AccessedNovember 2020 . - Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.
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