BLA submission includes data from TRANSCEND
NHL 001 trial evaluating liso-cel in patients with relapsed or
refractory large B-cell lymphoma, including diffuse large B-cell
lymphoma
Bristol-Myers Squibb Company (NYSE: BMY) today announced the
submission of its Biologics License Application (BLA) to the U.S.
Food and Drug Administration (FDA) for lisocabtagene maraleucel
(liso-cel), its autologous anti-CD19 chimeric antigen receptor
(CAR) T‑cell immunotherapy comprising individually formulated CD8+
and CD4+ CAR T cells for the treatment of adult patients with
relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after at
least two prior therapies.
The submission is based on the safety and efficacy results from
the TRANSCEND NHL 001 trial, evaluating liso-cel in 269 patients
with relapsed/refractory large B-cell lymphoma, including diffuse
large B-cell lymphoma (DLBCL). Bristol-Myers Squibb recently
presented data from this pivotal study at the American Society of
Hematology annual meeting.
Liso-cel has been granted Breakthrough Therapy (BT) and
Regenerative Medicine Advanced Therapy (RMAT) designations by the
FDA for relapsed/refractory aggressive large B-cell non-Hodgkin
lymphoma (NHL), including DLBCL, not otherwise specified (de novo
or transformed from indolent lymphoma), primary mediastinal B-cell
lymphoma (PMBCL) or Grade 3B follicular lymphoma (FL) and Priority
Medicines (PRIME) scheme by the European Medicines Agency for
relapsed/refractory DLBCL.
Liso-cel is an investigational compound that is not approved for
use in any country.
About Diffuse Large B-cell
Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common and
aggressive NHL, accounting for three out of every five cases.
Approximately one-third of patients with DLBCL relapse after
receiving first-line treatment, and about 10% have refractory
disease. Historically, median life expectancy for patients who
relapse or are refractory to current standard of care treatments is
approximately six months.
Bristol-Myers Squibb: Advancing Cancer
Research
At Bristol-Myers Squibb, patients are at the center of
everything we do. The goal of our cancer research is to increase
quality, long-term survival and make cure a possibility. We harness
our deep scientific experience, cutting-edge technologies and
discovery platforms to discover, develop and deliver novel
treatments for patients.
Building upon our transformative work and legacy in hematology
and Immuno-Oncology that has changed survival expectations for many
cancers, our researchers are advancing a deep and diverse pipeline
across multiple modalities. In the field of immune cell therapy,
this includes registrational chimeric antigen receptor (CAR) T-cell
agents for numerous diseases, and a growing early-stage pipeline
that expands cell and gene therapy targets, and technologies. We
are developing cancer treatments directed at key biological
pathways using our protein homeostasis platform, a research
capability that has been the basis of our approved therapies for
multiple myeloma and several promising compounds in early to
mid-stage development. Our scientists are targeting different
immune system pathways to address interactions between tumors, the
microenvironment and the immune system to further expand upon the
progress we have made and help more patients respond to treatment.
Combining these approaches is key to delivering new options for the
treatment of cancer and addressing the growing issue of resistance
to immunotherapy. We source innovation internally, and in
collaboration with academia, government, advocacy groups and
biotechnology companies, to help make the promise of
transformational medicines a reality for patients.
About Lisocabtagene Maraleucel
(liso-cel)
Liso-cel is an investigational chimeric antigen receptor (CAR)
T-cell therapy designed to target CD19, which is a surface
glycoprotein expressed during normal B-cell development and
maintained following malignant transformation of B cells. Liso-cel
aims to target CD19-expressing cells through a CAR construct that
includes an anti-CD19 single-chain variable fragment (scFv)
targeting domain for antigen specificity, a transmembrane domain, a
4-1BB costimulatory domain hypothesized to increase T-cell
proliferation and persistence, and a CD3-zeta T-cell activation
domain. The defined composition of CAR-positive viable T-cells
(consisting of CD8 and CD4 components) in liso-cel may reduce
product variability; however, the clinical significance of defined
composition is unknown.
About TRANSCEND NHL 001
TRANSCEND NHL 001 is an open-label, multicenter, pivotal phase 1
study to determine the safety, pharmacokinetics, and antitumor
activity of liso-cel in patients with relapsed/refractory B-cell
NHL, including DLBCL, PMBCL, Grade 3B FL. Mantle cell lymphoma is
investigated in a separate cohort. The primary outcome measures
included treatment-related adverse events, dose-limiting toxicities
and objective response rate. Secondary outcome measures included
complete response rate, duration of response, and progression-free
survival. The TRANSCEND program is a broad clinical program
evaluating liso-cel in multiple disease states and treatment
stages.
About Bristol-Myers
Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube, Facebook and
Instagram.
Cautionary Statement Regarding
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on historical performance and current expectations and
projections about our future financial results, goals, plans and
objectives and involve inherent risks, assumptions and
uncertainties, including internal or external factors that could
delay, divert or change any of them in the next several years, that
are difficult to predict, may be beyond our control and could cause
our future financial results, goals, plans and objectives to differ
materially from those expressed in, or implied by, the statements.
These risks, assumptions, uncertainties and other factors include,
among others, the possibility of unfavorable results from
additional studies involving liso-cel, that such product candidate
may not receive regulatory approval for the indications described
in this release in the currently anticipated timeline or at all
and, if approved, whether such product candidate for such
additional indications described in this release will be
commercially successful. No forward-looking statement can be
guaranteed. Forward-looking statements in this press release should
be evaluated together with the many risks and uncertainties that
affect Bristol-Myers Squibb’s business and market, particularly
those identified in the cautionary statement and risk factors
discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for
the year ended December 31, 2018, as updated by our subsequent
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
other filings with the Securities and Exchange Commission. The
forward-looking statements included in this document are made only
as of the date of this document and except as otherwise required by
applicable law, Bristol-Myers Squibb undertakes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events, changed circumstances
or otherwise.
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Bristol-Myers Squibb Company
Media Inquiries: media@bms.com 609-252-3345
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