Breyanzi offers a personalized treatment
option delivered as a one-time infusion that provides deep and
durable responses for patients with relapsed or refractory CLL or
SLL who have historically had no standard of care
In TRANSCEND CLL 004, the first pivotal
multicenter trial to evaluate a CAR T cell therapy in patients with
relapsed or refractory CLL or SLL, 20% of patients treated with
Breyanzi achieved a complete response (CR) with median duration of
CR not reached, along with an established safety profile
Breyanzi is now FDA approved for relapsed or
refractory large B-cell lymphoma and CLL or SLL, bringing this
differentiated CD19-directed CAR T cell therapy to more
patients
Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food
and Drug Administration (FDA) has granted accelerated approval of
Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed
chimeric antigen receptor (CAR) T cell therapy, for the treatment
of adult patients with relapsed or refractory chronic lymphocytic
leukemia (CLL) or small lymphocytic lymphoma (SLL) who have
received at least two prior lines of therapy, including a Bruton
tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2)
inhibitor. This indication is approved under accelerated approval
based on response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trial(s). In R/R
CLL or SLL, Breyanzi is delivered through a treatment process which
culminates in a one-time infusion* with a single dose containing 90
to 110 x 106 CAR-positive viable T cells. Please see the Important
Safety Information section below, including Boxed WARNINGS
for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic
Toxicities, and Secondary Hematological Malignancies.
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“CAR T cell therapies represent a transformative treatment
option for patients with certain types of blood cancers,” said
Bryan Campbell, senior vice president, Head of Commercial, Cell
Therapy, Bristol Myers Squibb. “For years, attempts to bring other
CAR T cell therapies to patients with relapsed or refractory CLL or
SLL met challenges and found little success. With the approval of
Breyanzi as the first CAR T for relapsed or refractory CLL or SLL,
we are now able to offer these patients a personalized option,
while further expanding access across the broadest array of B-cell
malignancies, to address this critical unmet need.”
CLL and SLL are among the most common types of B-cell lymphoma.
Treatments for people living with CLL or SLL primarily consist of
targeted therapies including BTK- and BCL-2 inhibitors. However,
patients often experience relapse or become refractory following
early-line treatment with these therapies and there is no
established standard of care for patients with double-class exposed
CLL or SLL. After relapsing or becoming refractory to these
therapies, patients have few options and poor outcomes, including
lack of durable complete responses.
The Phase 1/2 open-label, single-arm TRANSCEND CLL 004 study was
the first pivotal multicenter trial to evaluate a CAR T cell
therapy in patients with relapsed or refractory CLL or SLL. The CR
rate associated with Breyanzi treatment was 20% (95% CI:
11.1-31.8). Among patients who achieved a CR, median duration of
response was not reached (95% CI: 15 months-NR) at the time of data
cutoff. Among all responders (ORR = 45%; 95% CI: 32.3-57.5), median
duration of response was 35.3 months (95% CI: 12.4-NR). High rates
of minimal residual disease (MRD) negative status were observed
across patients treated with Breyanzi who achieved a CR, with an
MRD-negativity rate of 100% in the blood (95% CI: 75.3-100) and
92.3% in the bone marrow (95% CI: 64-99.8).
“CLL and SLL are currently considered incurable diseases with
few treatment options in the relapsed setting that can confer
complete responses, something that has historically been associated
with improved long-term outcomes,” said Tanya Siddiqi, M.D., lead
investigator and Associate Professor, Division of Lymphoma, City of
Hope National Medical Center. “The FDA approval of liso-cel in
relapsed or refractory CLL and SLL after treatment with prior BTKi
and BCL2i is a remarkable breakthrough, shifting the treatment
paradigm from continuous therapy with sequential regimens to
overcome drug resistance, to a one-time personalized T-cell based
approach that has the potential to offer patients complete and
lasting remission.”
Among 89 patients in the study treated with Breyanzi,
occurrences of cytokine release syndrome (CRS) and neurologic
events (NEs) were mostly low grade. Any grade CRS occurred in 83%
of patients, with Grade 3 CRS occurring in 9% of patients. No Grade
4/5 CRS events were reported. Any grade NEs were reported in 46% of
patients, with Grade 3 NEs reported in 20% of patients and one case
of Grade 4 NE reported. No Grade 5 NEs were reported.
“For people struggling with relapsed or refractory CLL or SLL,
current treatment choices are limited,” said Dr. Brian Koffman,
physician, CLL patient and cofounder, executive vice president and
chief medical officer of CLL Society. “The approval of Breyanzi as
the first CAR T cell therapy available for relapsed or refractory
CLL or SLL brings new hope to these patients with the potential for
durable responses after a single CAR T infusion. We are grateful to
the patients and their families who enter the trials and to all the
researchers involved in making possible this important new
treatment option in CLL and SLL.”
Bristol Myers Squibb offers various programs and resources to
address the needs of patients and caregivers, and provides support
that allows for access to therapies, including Breyanzi. Bristol
Myers Squibb also supports the patient and physician treatment
experience by providing Cell Therapy 360, a digital service
platform, which optimizes access to relevant information,
manufacturing updates, and patient and caregiver support.
About TRANSCEND CLL 004
TRANSCEND CLL 004 (NCT03331198) is a Phase 1/2 open-label,
single-arm, multicenter study evaluating Breyanzi in patients with
relapsed or refractory chronic lymphocytic leukemia or small
lymphocytic lymphoma. The Phase 1 dose escalation portion of the
study assessed the safety and recommended dose for the subsequent
Phase 2 expansion cohort. The Phase 2 portion of the study is
evaluating Breyanzi at the recommended dose from the Phase 1
monotherapy arm. The primary endpoint of the Phase 2 portion of the
study is complete response rate, including complete remission with
incomplete bone marrow recovery, based on independent review
committee according to the International Workshop on Chronic
Lymphocytic Leukemia (iwCLL) 2018 guidelines.
About CLL and SLL
Chronic lymphocytic leukemia (CLL) is one of the most common
types of leukemia in adults. In CLL, too many blood stem cells in
the bone marrow become abnormal lymphocytes, and these abnormal
cells have difficulty fighting infections. As the number of
abnormal cells grows, there is less room for healthy white blood
cells, red blood cells and platelets. Small lymphocytic lymphoma
(SLL) also affects the lymphocytes, with cancer cells found mostly
in the lymph nodes. While there are several treatments available
for CLL and SLL, there is a need for additional effective therapies
as there is no standard of care for relapsed or refractory CLL or
SLL after prior therapy with targeted agents, such as Bruton
tyrosine kinase (BTK) and B-cell lymphoma 2 (BCL-2) inhibitors.
Patients with relapsed or refractory disease have limited treatment
options and generally experience shorter periods of response with
each subsequent treatment.
About Breyanzi
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB
costimulatory domain, which enhances the expansion and persistence
of the CAR T cells. Breyanzi is made from a patient’s own T cells,
which are collected and genetically reengineered to become CAR T
cells that are then delivered via infusion as a one-time
treatment.
Breyanzi is approved in the U.S., Japan and Europe for the
second-line treatment of relapsed or refractory LBCL, and in Japan,
Europe, Switzerland, and Canada for relapsed and refractory LBCL
after two or more lines of systemic therapy. Bristol Myers Squibb’s
clinical development program for Breyanzi includes clinical studies
in other types of lymphoma. For more information, visit
clinicaltrials.gov.
* Treatment process includes leukapheresis, manufacturing,
administration, and adverse event monitoring.
Indication
BREYANZI is a CD19-directed genetically modified autologous T
cell immunotherapy indicated for the treatment of:
- adult patients with large B-cell lymphoma (LBCL), 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, who have:
- refractory disease to first-line chemoimmunotherapy or relapse
within 12 months of first-line chemoimmunotherapy; or
- refractory disease to first-line chemoimmunotherapy or relapse
after first-line chemoimmunotherapy and are not eligible for
hematopoietic stem cell transplantation (HSCT) due to comorbidities
or age; or
- relapsed or refractory disease after two or more lines of
systemic therapy.
Limitations of Use: BREYANZI is not
indicated for the treatment of patients with primary central
nervous system lymphoma.
- adult patients with relapsed or refractory chronic lymphocytic
leukemia (CLL) or small lymphocytic lymphoma (SLL) who have
received at least 2 prior lines of therapy, including a Bruton
tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2)
inhibitor.
This indication is approved under accelerated approval based on
response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trial(s).
Important Safety
Information
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES,
AND SECONDARY HEMATOLOGICAL MALIGNANCIES
- Cytokine Release Syndrome (CRS), including fatal or
life-threatening reactions, occurred in patients receiving
BREYANZI. Do not administer BREYANZI to patients with active
infection or inflammatory disorders. Treat severe or
life-threatening CRS with tocilizumab with or without
corticosteroids.
- Neurologic toxicities, including fatal or life-threatening
reactions, occurred in patients receiving BREYANZI, including
concurrently with CRS, after CRS resolution or in the absence of
CRS. Monitor for neurologic events after treatment with BREYANZI.
Provide supportive care and/or corticosteroids as needed.
- T cell malignancies have occurred following treatment of
hematologic malignancies with BCMA- and CD19-directed genetically
modified autologous T cell immunotherapies, including
BREYANZI.
- BREYANZI is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) called the
BREYANZI REMS.
Cytokine Release Syndrome
Cytokine release syndrome (CRS), including fatal or
life-threatening reactions, occurred following treatment with
BREYANZI. Among patients receiving BREYANZI for LBCL (N=418), CRS
occurred in 46% (190/418), including ≥ Grade 3 CRS in 3.1% of
patients. In patients receiving BREYANZI after two or more lines of
therapy for LBCL, CRS occurred in 46% (122/268), including ≥ Grade
3 CRS in 4.1% of patients. One patient had fatal CRS and 2 had
ongoing CRS at time of death. The median time to onset was 5 days
(range: 1 to 15 days). CRS resolved in 98% with a median duration
of 5 days (range: 1 to 17 days). In patients receiving BREYANZI
after one line of therapy for LBCL, CRS occurred in 45% (68/150),
including Grade 3 CRS in 1.3% of patients. The median time to onset
was 4 days (range: 1 to 63 days). CRS resolved in all patients with
a median duration of 4 days (range: 1 to 16 days).
Among patients receiving BREYANZI for CLL/SLL, CRS occurred in
83% (74/89), including Grade 3 CRS in 9% of patients. The median
time to onset was 4 days (range: 1 to 18 days). CRS resolved in 97%
with a median duration of 6 days (range: 2 to 37 days).
The most common manifestations of CRS (≥ 10% in LBCL or CLL/SLL)
included fever (94% LBCL; 97% CLL/SLL), hypotension (42% LBCL; 46%
CLL/SLL), tachycardia (28% LBCL), chills (23% LBCL; 43% CLL/SLL),
hypoxia (16% LBCL; 35% CLL/SLL), sinus tachycardia (22% CLL/SLL),
and headache (12% LBCL; 18% CLL/SLL).
Serious events that may be associated with CRS include cardiac
arrhythmias (including atrial fibrillation and ventricular
tachycardia), cardiac arrest, cardiac failure, diffuse alveolar
damage, renal insufficiency, capillary leak syndrome, hypotension,
hypoxia, and hemophagocytic lymphohistiocytosis/macrophage
activation syndrome (HLH/MAS).
Ensure that 2 doses of tocilizumab are available prior to
infusion of BREYANZI. Of the patients who received BREYANZI for
LBCL (n=418) and CLL/SLL (n=89), 23% (LBCL) and 64% (CLL/SLL)
received tocilizumab and/or a corticosteroid for CRS, including 10%
(LBCL) and 33% (CLL/SLL) who received tocilizumab only and 2.2%
(LBCL) and 2.2% (CLL/SLL) who received corticosteroids only.
Neurologic Toxicities
Neurologic toxicities that were fatal or life-threatening,
including immune effector cell-associated neurotoxicity syndrome
(ICANS), occurred following treatment with BREYANZI. Serious events
including cerebral edema and seizures occurred with BREYANZI. Fatal
and serious cases of leukoencephalopathy, some attributable to
fludarabine, also occurred.
In patients receiving BREYANZI after two or more lines of
therapy for LBCL, CAR T cell-associated neurologic toxicities
occurred in 35% (95/268), including ≥ Grade 3 cases in 12% of
patients. Three patients had fatal neurologic toxicity and 7 had
ongoing neurologic toxicity at time of death. The median time to
onset of neurotoxicity was 8 days (range: 1 to 46 days). Neurologic
toxicities resolved in 85% of patients with a median duration of 12
days (range: 1 to 87 days). In patients receiving BREYANZI after
one line of therapy for LBCL, CAR T cell-associated neurologic
toxicities occurred in 27% (41/150) of patients, including Grade 3
cases in 7% of patients. The median time to onset of neurologic
toxicity was 8 days (range: 1 to 63 days). The median duration of
neurologic toxicity was 6 days (range: 1 to 119 days). In all
patients combined receiving BREYANZI for LBCL, CAR T
cell-associated neurologic toxicities occurred in 33% (136/418),
including ≥ Grade 3 cases in 10% of patients. The median time to
onset was 8 days (range: 1 to 63), with 87% of cases developing by
16 days. Neurologic toxicities resolved in 85% of patients with a
median duration of 11 days (range: 1 to 119 days). Of patients
developing neurotoxicity, 77% (105/136) also developed CRS.
In patients receiving BREYANZI for CLL/SLL, CAR T
cell-associated neurologic toxicities occurred in 46% (41/89),
including Grade 3 cases in 20% of patients and a single Grade 4
case. The median time to onset of neurotoxicity was 7 days (range:
1 to 21 days), with 95% of cases developing by 16 days. Neurologic
toxicities resolved in 85% with a median duration of 7 days (range:
1 to 83 days). Of patients developing neurotoxicity, 95% (39/41)
also developed CRS.
The most common neurologic toxicities (≥ 5% in LBCL or CLL)
included encephalopathy (20% LBCL; 36% CLL/SLL), tremor (13% LBCL;
14% CLL/SLL), aphasia (8% LBCL; 8% CLL/SLL), headache (6% LBCL; 9%
CLL/SLL), dizziness (6% LBCL), and delirium (5% LBCL; 12%
CLL/SLL).
CRS and Neurologic Toxicities Monitoring
Monitor patients daily for at least 7 days following BREYANZI
infusion at a REMS-certified healthcare facility for signs and
symptoms of CRS and neurologic toxicities and assess for other
causes of neurological symptoms. Monitor patients for signs and
symptoms of CRS and neurologic toxicities for at least 4 weeks
after infusion and treat promptly. At the first sign of CRS,
institute treatment with supportive care, tocilizumab, or
tocilizumab and corticosteroids as indicated. Manage neurologic
toxicity with supportive care and/or corticosteroid as needed.
Counsel patients to seek immediate medical attention should signs
or symptoms of CRS or neurologic toxicity occur at any time.
BREYANZI REMS
Because of the risk of CRS and neurologic toxicities, BREYANZI
is available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.
The required components of the BREYANZI REMS are:
- Healthcare facilities that dispense and administer BREYANZI
must be enrolled and comply with the REMS requirements.
- Certified healthcare facilities must have on-site, immediate
access to tocilizumab.
- Ensure that a minimum of 2 doses of tocilizumab are available
for each patient for infusion within 2 hours after BREYANZI
infusion, if needed for treatment of CRS.
Further information is available at www.BreyanziREMS.com, or
contact Bristol-Myers Squibb at 1-866-340-7332.
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of BREYANZI.
Serious hypersensitivity reactions, including anaphylaxis, may be
due to dimethyl sulfoxide (DMSO).
Serious Infections
Severe infections, including life-threatening or fatal
infections, have occurred in patients after BREYANZI infusion. In
patients receiving BREYANZI, infections of any grade occurred in
36% (LBCL) and 35% (CLL/SLL), with Grade 3 or higher infections
occurring in 12% (LBCL) and 16% (CLL/SLL) of all patients. Grade 3
or higher infections with an unspecified pathogen occurred in 7%
(LBCL) and 10% (CLL/SLL), bacterial infections in 4.3% (LBCL) and
2.2% (CLL/SLL), viral infections in 1.9% (LBCL) and 1.1% (CLL/SLL),
and fungal infections in 0.5% (LBCL) and 2.2% (CLL/SLL).
Febrile neutropenia developed after BREYANZI infusion in 8%
(LBCL) and 12% (CLL/SLL) of patients. Febrile neutropenia may be
concurrent with CRS. In the event of febrile neutropenia, evaluate
for infection and manage with broad spectrum antibiotics, fluids,
and other supportive care as medically indicated.
Monitor patients for signs and symptoms of infection before and
after BREYANZI administration and treat appropriately. Administer
prophylactic antimicrobials according to standard institutional
guidelines. Avoid administration of BREYANZI in patients with
clinically significant, active systemic infections.
Viral reactivation: Hepatitis B virus (HBV) reactivation, in
some cases resulting in fulminant hepatitis, hepatic failure, and
death, can occur in patients treated with drugs directed against B
cells. In patients who received BREYANZI, 15 of 16 LBCL patients,
and all 9 CLL/SLL patients with a prior history of HBV were treated
with concurrent antiviral suppressive therapy. Perform screening
for HBV, HCV, and HIV in accordance with clinical guidelines before
collection of cells for manufacturing. In patients with prior
history of HBV, consider concurrent antiviral suppressive therapy
to prevent HBV reactivation per standard guidelines.
Prolonged Cytopenias
Patients may exhibit cytopenias not resolved for several weeks
following lymphodepleting chemotherapy and BREYANZI infusion. Grade
3 or higher cytopenias persisted at Day 29 following BREYANZI
infusion in 36% (LBCL) and 45% (CLL/SLL) of patients, and included
thrombocytopenia in 28% (LBCL) and 23% (CLL/SLL), neutropenia in
21% (LBCL) and 35% (CLL/SLL), and anemia in 6% (LBCL) and 12%
(CLL/SLL). Monitor complete blood counts prior to and after
BREYANZI administration.
Hypogammaglobulinemia
B-cell aplasia and hypogammaglobulinemia can occur in patients
receiving BREYANZI. In patients receiving BREYANZI,
hypogammaglobulinemia was reported as an adverse reaction in 11%
(LBCL) and 14% (CLL/SLL) of patients. Hypogammaglobulinemia, either
as an adverse reaction or laboratory IgG level below 500 mg/dL
after infusion, was reported in 28% (LBCL) and 37% (CLL/SLL) of
patients. Monitor immunoglobulin levels after treatment with
BREYANZI and manage using infection precautions, antibiotic
prophylaxis, and immunoglobulin replacement as clinically
indicated.
Live vaccines: The safety of immunization with live viral
vaccines during or following BREYANZI treatment has not been
studied. Vaccination with live virus vaccines is not recommended
for at least 6 weeks prior to the start of lymphodepleting
chemotherapy, during BREYANZI treatment, and until immune recovery
following treatment with BREYANZI.
Secondary Malignancies
Patients treated with BREYANZI may develop secondary
malignancies. T cell malignancies have occurred following treatment
of hematologic malignancies with BCMA- and CD19-directed
genetically modified autologous T cell immunotherapies, including
BREYANZI. Mature T cell malignancies, including CAR-positive
tumors, may present as soon as weeks following infusion, and may
include fatal outcomes. Monitor lifelong for secondary
malignancies. In the event that a secondary malignancy occurs,
contact Bristol-Myers Squibb at 1- 888-805-4555 for reporting and
to obtain instructions on collection of patient samples for
testing.
Effects on Ability to Drive and Use Machines
Due to the potential for neurologic events, including altered
mental status or seizures, patients receiving BREYANZI are at risk
for developing altered or decreased consciousness or impaired
coordination in the 8 weeks following BREYANZI administration.
Advise patients to refrain from driving and engaging in hazardous
occupations or activities, such as operating heavy or potentially
dangerous machinery, for at least 8 weeks.
Immune Effector Cell-Associated Hemophagocytic
Lymphohistiocytosis-Like Syndrome (IEC-HS)
Immune Effector Cell-Associated Hemophagocytic
Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or
life-threatening reactions, occurred following treatment with
BREYANZI. Three of 89 (3%) safety evaluable patients with R/R
CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to
18 days. Two of the 3 patients developed IEC-HS in the setting of
ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS
was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one
had ongoing IEC-HS at time of death. IEC-HS is a life-threatening
condition with a high mortality rate if not recognized and treated
early. Treatment of IEC-HS should be administered per current
practice guidelines.
Adverse Reactions
The most common nonlaboratory adverse reactions (incidence ≥
30%) in:
- LBCL are fever, cytokine release syndrome, fatigue,
musculoskeletal pain, and nausea. The most common Grade 3-4
laboratory abnormalities (≥ 30%) include lymphocyte count decrease,
neutrophil count decrease, platelet count decrease, and hemoglobin
decrease.
- CLL/SLL are cytokine release syndrome, encephalopathy, fatigue,
musculoskeletal pain, nausea, and diarrhea. The most common Grade
3-4 laboratory abnormalities (≥ 30%) in CLL/SLL include neutrophil
count decrease, white blood cell decrease, hemoglobin decrease,
platelet count decrease, and lymphocyte count decrease.
Please see full Prescribing Information, including
Boxed WARNINGS and Medication Guide.
Bristol Myers Squibb: Creating a Better
Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision —
transforming patients’ lives through science. The goal of the
company’s cancer research is to deliver medicines that offer each
patient a better, healthier life and to make cure a possibility.
Building on a legacy across a broad range of cancers that have
changed survival expectations for many, Bristol Myers Squibb
researchers are exploring new frontiers in personalized medicine
and, through innovative digital platforms, are turning data into
insights that sharpen their focus. Deep understanding of causal
human biology, cutting-edge capabilities and differentiated
research platforms uniquely position the company to approach cancer
from every angle.
Cancer can have a relentless grasp on many parts of a patient’s
life, and Bristol Myers Squibb is committed to taking actions to
address all aspects of care, from diagnosis to survivorship. As a
leader in cancer care, Bristol Myers Squibb is working to empower
all people with cancer to have a better future.
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 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,
whether Breyanzi (lisocabtagene maraleucel) for such additional
indication described in this release will be commercially
successful, that any marketing approvals, if granted, may have
significant limitations on their use, and that continued approval
of such product candidate for such additional indication described
in this release may be contingent upon verification and description
of clinical benefit in confirmatory trial(s). 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, 2023, 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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