- 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
Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a
global clinical-stage biopharmaceutical company engaged in the
discovery and development of novel cell therapies for oncology and
other indications, today announced that new and updated data from
CARTITUDE-1 and LEGEND-2 studies, respectively, will be presented
at the 62nd American Society of Hematology (ASH) Annual Meeting and
Exposition taking place virtually December 5-8, 2020.
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 Ying Huang, PhD,
interim-CEO and CFO of Legend Biotech. “With our successful
clinical efforts and the Company’s collaboration with Janssen, we
are uniquely positioned to deliver a novel therapy to patients with
multiple myeloma.”
On Saturday, December 5th, during the Myeloma session entitled:
Myeloma/Amyloidosis: Therapy, excluding Transplantation: Novel
Therapies Targeting B Cell Maturation Antigen in
Relapsed/Refractory Multiple Myeloma, the Phase 1b/2 clinical
efficacy and safety data for cilta-cel from the CARTITUDE-1 study
will be presented.
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.
Title
Date/Time
Oral Presentation
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
Saturday, Dec. 5 12:00 p.m.
PT
Poster Presentations
Abstract #1412
Patient Expectations and
Perceptions of Treatment in CARTITUDE-1: Phase 1b/2 Study of
Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple
Myeloma
Saturday, Dec. 5 7:00 a.m. - 3:30
p.m. PT
Abstract #2291
Health-Related Quality of Life in
the CARTITUDE-1 Study of Ciltacabtagene Autoleucel for
Relapsed/Refractory Multiple Myeloma
Sunday, Dec. 6 7:00 a.m. - 3:30
p.m. PT
Abstract #2304
Chimeric Antigen Receptor T Cell
Therapy in the Relapsed or Refractory Multiple Myeloma with
Extramedullary Disease--a Single Institution Observation in China
(LEGEND-2)
Sunday, Dec. 6
7:00 a.m. - 3:30 p.m. PT
Abstract #3240
Cytokine Release Syndrome in
Patients With Relapsed/Refractory Multiple Myeloma Treated With
Ciltacabtagene Autoleucel in the Phase 1b/2 CARTITUDE-1 Study
Monday, Dec. 7 7:00 a.m. - 3:30
p.m. PT
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 Japan for the treatment
of patients with multiple myeloma who have received at least 3
prior lines of therapy or are double refractory to a PI and IMiD®,
received a PI, an IMiD, and anti-CD38 antibody and documented
disease progression within 12 months of starting the most recent
therapy.1
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 China evaluating the efficacy
and safety of LCAR-B38M CAR-T cells for the treatment of relapsed
or refractory multiple myeloma.2
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 U.S. and Europe and LCAR-B38M CAR-T cells in China,
that is being studied in a comprehensive clinical development
program for the treatment of patients with relapsed or refractory
multiple myeloma and in earlier lines of treatment. The design
consists of a structurally differentiated CAR-T with two
BCMA-targeting single domain antibodies. In December 2017, Legend
Biotech, Inc. entered into an exclusive worldwide license and
collaboration agreement with Janssen Biotech, Inc. (Janssen) to
develop and commercialize cilta-cel.
In addition to a Breakthrough Therapy Designation (BTD) granted
in the U.S. in December 2019, cilta-cel received a PRIority
MEdicines (PRiME) designation from the European Commission in April
2019, and a BTD in China in August 2020. In addition, Orphan Drug
Designation was granted for cilta-cel by the U.S. FDA in February
2019, and by the European Commission in February 2020.
About Legend Biotech Legend Biotech is a global
clinical-stage biopharmaceutical company engaged in the discovery
and development of novel cell therapies for oncology and other
indications. Our team of over 800 employees across the United
States, China and Europe, along with our differentiated technology,
global development, and manufacturing strategies and expertise,
provide us with the strong potential to discover, develop, and
manufacture cutting edge cell therapies for patients in need.
We are engaged in a strategic collaboration with Janssen
Biotech, Inc. to develop and commercialize our lead product
candidate, ciltacabtagene autoleucel, an investigational
BCMA-targeted CAR-T cell therapy for patients living with multiple
myeloma. This candidate is currently being studied in
registrational clinical trials.
To learn more about Legend Biotech, visit us on LinkedIn, or on
Twitter @LegendBiotech or at www.legendbiotech.com.
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 Securities and Exchange Commission on June 8, 2020.
Any forward-looking statements contained in this press release
speak only as of the date hereof, and Legend Biotech specifically
disclaims any obligation to update any forward-looking statement,
whether as a result of new information, future events or otherwise.
Readers should not rely upon the information on this page as
current or accurate after its publication date.
References
- 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 .
Accessed November 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.
- National Cancer Institute. NCI dictionary of cancer terms:
relapsed. Available at:
https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866.
Accessed November 2020.
- National Cancer Institute. NCI dictionary of cancer terms:
refractory. Available at:
https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245.
Accessed November 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.
- American Cancer Society. Multiple myeloma: early detection,
diagnosis and staging. Available at:
https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf.
Accessed November 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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version on businesswire.com: https://www.businesswire.com/news/home/20201105005104/en/
For Investor Relations inquiries, please contact: Jessie
Yeung, Head of Corporate Finance and Investor Relations, Legend
Biotech USA Inc. jessie.yeung@legendbiotech.com or
investor@legendbiotech.com or media@legendbiotech.com Surabhi
Verma, Manager of Investor Relations and Corporate Communications,
Legend Biotech USA Inc. Surabhi.Verma@legendbiotech.com
For Medical Affairs inquiries, please contact: Tonia
Nesheiwat, Executive Director, Medical Affairs, Legend Biotech USA
Inc. tonia.nesheiwat@legendbiotech.com or
medicalinformation@legendbiotech.com
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