Three-year follow-up results from TRANSFORM
show ongoing event-free survival and durable responses with
Breyanzi compared to standard of care
Results from a subgroup analysis from mantle
cell lymphoma cohort of TRANSCEND NHL 001 show Breyanzi
demonstrated consistent clinical benefit regardless of number of
prior lines of therapy, supporting use of Breyanzi in earlier lines
of treatment
Data from bridging therapy subgroup analysis
of TRANSCEND FL show consistent efficacy with high response rates
and a consistent safety profile regardless of receiving prior
bridging therapy, supporting Breyanzi’s differentiated profile in
relapsed or refractory follicular lymphoma
Bristol Myers Squibb (NYSE: BMY) today announced data from three
studies evaluating Breyanzi® (lisocabtagene maraleucel; liso-cel),
including long-term data with three-year follow-up from the Phase 3
TRANSFORM trial of Breyanzi as a second-line treatment in patients
with relapsed or refractory large B-cell lymphoma (LBCL), results
from a subgroup analysis evaluating the efficacy and safety of
Breyanzi by number of prior lines of therapy in the mantle cell
lymphoma (MCL) cohort of the TRANSCEND NHL 001 trial, and results
from a subgroup analysis assessing the efficacy and safety of
Breyanzi based on use of bridging therapy in the TRANSCEND FL trial
in relapsed or refractory follicular lymphoma (FL).
The data, presented during the 2024 American Society of Clinical
Oncology (ASCO) Annual Meeting, underscore Breyanzi as a
transformative therapy with demonstrated clinically meaningful
outcomes across the broadest array of B-cell malignancies.
Results from the primary analysis of TRANSCEND FL were
simultaneously published in Nature Medicine.
“This year’s ASCO is another exciting moment in the cascade of
milestones for Breyanzi, our differentiated CAR T cell therapy
approved for the broadest range of B-cell malignancies of any CAR T
cell therapy,” said Anne Kerber, M.D., senior vice president, head
of Late Clinical Development, Hematology, Oncology, Cell Therapy
(HOCT), Bristol Myers Squibb. “The new data being presented from
our vast clinical development program are an incredible showcase of
the improved outcomes and consistent safety profile Breyanzi
provides for patients with diverse types of lymphomas, offering a
definitive therapy with demonstrated improved outcomes, and we
remain dedicated to leading the advancement of innovative therapies
to improve outcomes for a wide range of patients.”
Notably, Breyanzi was recently granted accelerated approval by
the U.S. Food and Drug Administration (FDA) for adult patients with
relapsed or refractory FL who have received two or more prior lines
of systemic therapy. The FDA also granted Breyanzi approval for
patients with relapsed or refractory MCL who have received at least
two prior lines of systemic therapy, including a Bruton tyrosine
kinase (BTK) inhibitor, expanding its use to include four distinct
types of B-cell lymphomas.
Please see the Important Safety Information section below,
including Boxed WARNINGS for Breyanzi regarding Cytokine
Release Syndrome (CRS), Neurologic Toxicities, and Secondary
Hematological Malignancies.
Long-Term Results from TRANSFORM
(Abstract #7013) In the pivotal, global, randomized,
multicenter, Phase 3 TRANSFORM study, 184 patients with primary
refractory LBCL or relapsed disease within <12 months after first-line therapy who were
eligible for autologous hematopoietic stem cell transplant (HSCT)
were randomized to receive Breyanzi (n=92) or salvage chemotherapy
followed by high-dose chemotherapy and autologous HSCT (standard of
care, SoC; n=92).
With a median follow-up of 33.9 months, Breyanzi demonstrated
sustained significant clinical benefit with continued improvements
in the primary endpoint of event-free survival (EFS), and secondary
endpoints of progression-free survival (PFS), overall responses and
duration of response (DOR) compared to SoC, consistent with the
primary analysis results.
With longer follow-up, EFS with Breyanzi was 29.5 months (95%
CI: 9.5-NR) compared to 2.4 months with SoC (95% CI: 2.2-4.9) (HR:
0.375; 95% CI: 0.259-0.542). The 36-month EFS rate with Breyanzi
was 45.8% (95% CI: 35.2-56.5) vs. 19.1% (95% CI: 11.0-27.3) for
SoC. The overall response rate (ORR) with Breyanzi was 87% (95% CI:
78.3-93.1) with 74% of patients achieving a complete response (CR)
(95% CI: 63.7-82.5) vs. a 49% (95% CI: 38.3-59.6) ORR with SoC and
a 43% (95% CI: 33.2-54.2) CR rate. DOR was not reached with
Breyanzi (95% CI: 16.9-NR) and was 9.1 months with SoC (95%
CI:.1-NR) (HR:0.603; 95% CI: 0.364.1.000). Additionally, PFS was
not reached with Breyanzi (95% CI: 12.6-NR) vs. 6.2 months (95% CI:
4.3-8.6) for SoC (HR: 0.422; 95% CI: 0.279-0.639). The 36-month PFS
rate for Breyanzi was 50.9% (95% CI: 39.9-62.0) and was 26.5% (95%
CI: 15.9-37.1) with SoC.
“The long-term data from TRANSFORM builds upon the remarkable
results from the primary analysis, with liso-cel continuing to
demonstrate deep and durable responses and improved event-free and
progression-free survival along with a well-established safety
profile,” said Manali Kamdar, M.D., lead investigator of the
TRANSFORM study and Associate Professor, Clinical Director of
Lymphoma Services, Division of Hematology, Hematologic Malignancies
and Stem Cell Transplantation, University of Colorado Cancer
Center. “This sustained clinical benefit with a median follow-up of
three years is extremely meaningful for patients with relapsed or
refractory LBCL, and the results reinforce the value of using a CAR
T cell therapy such as liso-cel earlier in the treatment
paradigm.”
In the patient-centric trial, which allowed for crossover, 61
patients (66%) in the SoC arm crossed to receive Breyanzi. With
longer follow-up, median overall survival (OS) was not reached for
either arm, and the 36-month OS rate was numerically higher for
Breyanzi (62.8% [95% CI: 52.7-72.9] vs. 51.8% [95% CI: 41.2-62.4])
(HR: 0.757; 95% CI: 0.481-1.191).
Additionally, Breyanzi continued to demonstrate a consistent
safety profile with no new safety signals observed.
Results from Subgroup Analyses from the
MCL Cohort of TRANSCEND NHL 001 (Abstract #7016) and TRANSCEND FL
(Abstract #7068) The MCL cohort of TRANSCEND NHL 001
enrolled adults with relapsed or refractory disease after two or
more prior lines of therapy, including a BTK inhibitor. In a
subgroup analysis reporting outcomes for patients treated with
Breyanzi by number of prior lines of therapy and response to prior
BTK inhibitor, Breyanzi showed similar efficacy across most
subgroups based on overall responses (ORR), complete responses
(CR), median duration of response (DOR), progression-free survival
(PFS) and overall survival (OS), including in heavily-pretreated
patients. The greatest benefit was observed in patients who had
received 2-4 prior lines of therapy. Numerically shorter DOR was
observed in patients who had received >5 prior lines of therapy and those whose
disease was refractory to prior treatment with a BTK inhibitor. The
safety profile of Breyanzi was consistent across subgroups and
well-tolerated with low rates of severe cytokine release syndrome
(CRS) and neurologic events (NE).
The subgroup analysis for TRANSCEND FL in second-line plus
relapsed or refractory FL, including second-line high-risk FL,
assessed outcomes in patients by bridging therapy status. The
primary endpoint of ORR was similar in patients who received
bridging therapy (n=45; 93%) and patients who did not receive
bridging therapy (n=79; 99%). CR rates were consistently high
across both subgroups (93% in bridging therapy and 95% in
non-bridging therapy), with all patients who received bridging
therapy and responded to Breyanzi treatment achieving CR. Median
DOR, PFS, and OS were not reached in either subgroup, with a median
follow-up of 18.9 months. Breyanzi exhibited a consistent safety
profile across both groups, with low rates of any-grade CRS (51% in
bridging therapy subgroup and 62% in non-bridging therapy subgroup)
and any-grade NEs (12% in bridging therapy subgroup and 17% in
non-bridging therapy subgroup). Grade 3 CRS (0% vs 1%), NEs (6% vs
0%) and infections (2% vs 7%) were similarly low across subgroups,
with no Grade 4 or 5 events.
“The subgroup analyses from the MCL cohort of TRANSCEND NHL 001
and TRANSCEND FL further demonstrate liso-cel's potential as a
treatment option for a broad patient population with relapsed or
refractory MCL or FL,” said M. Lia Palomba, M.D., TRANSCEND
investigator and lymphoma and cell therapy specialist, Memorial
Sloan Kettering Cancer Center. “In relapsed or refractory MCL,
liso-cel demonstrated clinically meaningful and durable disease
control across subgroups, including in earlier lines of treatment
where there remains a critical unmet need. Additionally, results
from the subgroup analysis from TRANSCEND FL show the consistent
clinical benefit of using liso-cel for relapsed or refractory FL
with or without prior bridging therapy, with high response rates
regardless of bridging status, further expanding the use of
liso-cel for these patients.”
About TRANSFORM TRANSFORM
(NCT03575351) is a pivotal, global, randomized, multicenter Phase 3
trial evaluating Breyanzi compared to current standard therapy
regimens (platinum-based salvage chemotherapy followed by high-dose
chemotherapy and HSCT in patients responding to salvage
chemotherapy) in patients with large B-cell lymphoma (LBCL) that
was primary refractory or relapsed within 12 months after
CD20-antibody and anthracycline containing first-line therapy.
Patients were randomized to receive Breyanzi or standard of care
salvage therapy, including rituximab plus dexamethasone, high-dose
cytarabine, and cisplatin (R-DHAP), rituximab plus ifosfamide,
carboplatin and etoposide (R-ICE), or rituximab plus gemcitabine,
dexamethasone and cisplatin (R-GDP) per the investigators’ choice
before proceeding to high-dose chemotherapy (HDCT) and
hematopoietic stem cell transplant (HSCT). The primary endpoint of
the study was event-free survival (EFS), defined as time from
randomization to death from any cause, progressive disease, failure
to achieve complete response or partial response, or start of new
antineoplastic therapy due to efficacy concerns, whichever occurs
first. Complete response (CR) rate was a key secondary endpoint.
Other efficacy endpoints included progression-free survival (PFS),
overall survival (OS), overall response rate (ORR) and duration of
response (DOR).
About TRANSCEND NHL 001
TRANSCEND NHL 001 (NCT02631044) is an open-label, multicenter,
pivotal, Phase 1, single-arm, seamless-design study to determine
the safety, pharmacokinetics and antitumor activity of Breyanzi in
patients with relapsed or refractory B-cell non-Hodgkin lymphoma
(NHL), including diffuse LBCL, high-grade B-cell lymphoma, primary
mediastinal B-cell lymphoma, follicular lymphoma (FL) Grade 3B and
mantle cell lymphoma (MCL). The primary outcome measures are
treatment-related adverse events, dose-limiting toxicities and
overall response rate. Secondary outcome measures include complete
response rate, duration of response, and progression-free
survival.
About TRANSCEND FL
TRANSCEND FL (NCT04245839) is an open-label, global, multicenter,
Phase 2, single-arm study to determine the efficacy and safety of
Breyanzi in patients with relapsed or refractory indolent B-cell
NHL, including FL. The primary outcome measure is ORR, including
best overall response of complete response or partial response as
determined by an Independent Review Committee. Secondary outcome
measures include CR rate, DOR, PFS, and safety.
About LBCL LBCL refers to
several subtypes of NHL, with diffuse large B-cell lymphoma (DLCBL)
being the most common and aggressive form of the disease. Large
B-cell lymphomas are cancers that start in the lymphocytes and
affect immune cells called B lymphocytes, which are a type of white
blood cell. LBCL accounts for about one out of every three cases of
NHL, and occurs most often in older people, with a median age of 66
at diagnosis. Survival may vary depending on prognostic factors
such as age, general health and stage of disease.
About MCL MCL is an
aggressive, rare form of NHL, representing roughly 3% of all NHL
cases. MCL originates from cells in the “mantle zone” of the lymph
node. MCL occurs more frequently in older adults with an average
age at diagnosis in the mid-60s, and it is more often found in
males than in females. In MCL, relapse after initial treatment is
common, and for most, the disease eventually progresses or
returns.
About FL FL is the second
most common form of NHL and the most common subtype of indolent
NHL, accounting for 20 to 30 percent of all NHL cases. Most
patients with FL are over 50 years of age when they are diagnosed.
FL develops when white blood cells cluster together to form lumps
in a person’s lymph nodes or organs. It is characterized by periods
of remission and relapse, and the disease becomes more difficult to
treat after relapse or disease progression.
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. for the treatment of relapsed
or refractory LBCL after at least one prior line of therapy, and
for the treatment of relapsed or refractory chronic lymphocytic
leukemia or small lymphocytic lymphoma after two prior lines of
therapy, and for the treatment of relapsed or refractory follicular
lymphoma in adult patients who have received two or more prior
lines of systemic therapy, and for the treatment of relapsed or
refractory mantle cell lymphoma in patients who have received at
least two prior lines of systemic therapy, including a Bruton
tyrosine kinase (BTK) inhibitor. Breyanzi is also approved in 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.
Indications 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).
- adult patients with relapsed or refractory follicular lymphoma
(FL) who have received 2 or more prior lines of systemic therapy.
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).
- adult patients with relapsed or refractory mantle cell lymphoma
(MCL) who have received at least 2 prior lines of systemic therapy,
including a Bruton tyrosine kinase (BTK) inhibitor.
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. In clinical trials of BREYANZI, which enrolled a total of
702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54%
of patients, including ≥ Grade 3 CRS in 3.2% of patients. The
median time to onset was 5 days (range: 1 to 63 days). CRS resolved
in 98% of patients with a median duration of 5 days (range: 1 to 37
days). One patient had fatal CRS and 5 patients had ongoing CRS at
the time of death. The most common manifestations of CRS (≥10%)
were fever, hypotension, tachycardia, chills, hypoxia, and
headache.
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.
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 clinical trials of BREYANZI, CAR T cell-associated neurologic
toxicities occurred in 31% of patients, including ≥ Grade 3 cases
in 10% of patients. The median time to onset of neurotoxicity was 8
days (range: 1 to 63 days). Neurologic toxicities resolved in 88%
of patients with a median duration of 7 days (range: 1 to 119
days). Of patients developing neurotoxicity, 82% also developed
CRS.
The most common neurologic toxicities (≥5%) included
encephalopathy, tremor, aphasia, headache, dizziness, and
delirium.
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
clinical trials of BREYANZI, infections of any grade occurred in
34% of patients, with Grade 3 or higher infections occurring in 12%
of all patients. Grade 3 or higher infections with an unspecified
pathogen occurred in 7%, bacterial infections in 3.7%, viral
infections in 2%, and fungal infections in 0.7% of patients. One
patient who received 4 prior lines of therapy developed a fatal
case of John Cunningham (JC) virus progressive multifocal
leukoencephalopathy 4 months after treatment with BREYANZI. One
patient who received 3 prior lines of therapy developed a fatal
case of cryptococcal meningoencephalitis 35 days after treatment
with BREYANZI.
Febrile neutropenia developed after BREYANZI infusion in 8% 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 clinical trials of BREYANZI, 35 of 38 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. In
clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted
at Day 29 following BREYANZI infusion in 35% of patients, and
included thrombocytopenia in 25%, neutropenia in 22%, and anemia in
6% of patients. Monitor complete blood counts prior to and after
BREYANZI administration.
Hypogammaglobulinemia
B-cell aplasia and hypogammaglobulinemia can occur in patients
receiving BREYANZI. In clinical trials of BREYANZI,
hypogammaglobulinemia was reported as an adverse reaction in 10% of
patients. Hypogammaglobulinemia, either as an adverse reaction or
laboratory IgG level below 500 mg/dL after infusion, was reported
in 30% 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 adverse reaction(s) (incidence ≥30%) in:
LBCL are fever, cytokine release syndrome, fatigue,
musculoskeletal pain, and nausea. The most common Grade 3-4
laboratory abnormalities include lymphocyte count decrease,
neutrophil count decrease, platelet count decrease, and hemoglobin
decrease.
CLL/SLL are cytokine release syndrome, encephalopathy, fatigue,
musculoskeletal pain, nausea, edema, and diarrhea. The most common
Grade 3-4 laboratory abnormalities include neutrophil count
decrease, white blood cell decrease, hemoglobin decrease, platelet
count decrease, and lymphocyte count decrease.
FL is cytokine release syndrome. The most common Grade 3-4
laboratory abnormalities include lymphocyte count decrease,
neutrophil count decrease, and white blood cell decrease.
MCL are cytokine release syndrome, fatigue, musculoskeletal
pain, and encephalopathy. The most common Grade 3-4 laboratory
abnormalities include neutrophil count decrease, white blood cell
decrease, and platelet count decrease.
Please see full Prescribing Information,
including Boxed WARNINGS and Medication
Guide.
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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
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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
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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 the additional indication described
in this release will be commercially successful, any marketing
approvals, if granted, may have significant limitations on their
use, and that continued approval of Breyanzi for such additional
indication described in this release may be contingent upon
verification and description of clinical benefit in confirmatory
trials. 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
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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
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Bristol Myers Squibb (NYSE:BMY)
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Bristol Myers Squibb (NYSE:BMY)
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