Studies highlight the range of targets and
molecular approaches within the BMS multiple myeloma portfolio
including bispecific T cell engager alnuctamab, first-in-class
anti-BCMA CAR T cell therapy Abecma, GPRC5D CAR T
(BMS-986393/CC-95266) and novel oral CELMoDTM agents mezigdomide
and iberdomide
Bristol Myers Squibb (NYSE: BMY) today announced the first
disclosure of results and presentation of new research from its
multiple myeloma portfolio across targets and molecular approaches
at the 64th American Society of Hematology (ASH) Annual Meeting and
Exposition, underscoring the company’s commitment to raising
standards to transform multiple myeloma outcomes for every
patient.
“At ASH this year, we are highlighting the next wave of advances
from our diverse multiple myeloma portfolio, reflecting our
strategy of leveraging an array of approaches and targets against
the disease,” said Samit Hirawat, M.D., executive vice president,
chief medical officer, Global Drug Development, Bristol Myers
Squibb. “Through continued partnership with the multiple myeloma
community, we are working to push toward a reality in which every
patient would have an opportunity to receive a tailored treatment
option that offers the best possible outcomes.”
Results being presented at ASH highlight scientific progress
across bispecific T cell engagers (TCE), chimeric antigen receptor
(CAR) T cell therapies and novel CELMoDTM agents in advancing the
treatment of relapsed/refractory multiple myeloma and include:
- First multicenter results from the Phase 1 study of bispecific
TCE alnuctamab, administered subcutaneously every four weeks after
six months, showing a reduction in inflammatory toxicity relative
to intravenous administration, while maintaining anti-tumor
activity with deep responses (Oral Presentation #162)
- First disclosure of Phase 1 results for GPRC5D CAR T
(BMS-986393/CC-95266), demonstrating deep and durable responses
with a manageable safety profile across all dose levels, including
patients previously treated with a B-cell maturation antigen
(BCMA)-directed CAR T cell therapy (Oral Presentation #364)
- Two first disclosures of results from cohorts 2a and 2c of the
Phase 2 KarMMa-2 trial evaluating Abecma® (idecabtagene vicleucel),
demonstrating durable responses and predictable safety in patients
with multiple myeloma after early relapse or suboptimal response to
stem cell transplant (Oral Presentation #361, Poster Presentation
#3314)
- First results from the dose expansion cohort of the mezigdomide
Phase 1/2 study evaluating the novel oral CELMoD agent with
dexamethasone (DEX), showing durable efficacy and a manageable
safety profile in patients who were highly refractory to multiple
prior therapies (Oral Presentation #568)
- New results from a cohort with patients previously exposed to a
BCMA-targeted therapy of the iberdomide Phase 1/2 study, evaluating
the novel oral CELMoD agent with DEX, demonstrating clinically
meaningful efficacy and safety regardless of type of prior
anti-BCMA treatment (Poster Presentation #1918)
“Multiple myeloma continues to be an immensely challenging
disease which affects patients across a number of demographics,
fitness levels and comorbidities. While scientific advances have
driven significant improvements in survival, the disease remains
characterized by relapses and a disease burden that greatly impacts
a patient’s quality of life,” said Brian Durie, M.D., chairman of
the board of the International Myeloma Foundation. “These promising
data at ASH represent important progress, and I am encouraged by
the next wave of potential advances across a diverse range of
targets and platforms, which may provide treating physicians with
many options that can be tailored for unique patient needs.”
Alnuctamab
(BMS-986349/CC-93269) Phase 1 Study
Results Alnuctamab is a bispecific T cell engager (TCE)
that simultaneously binds myeloma cells expressing B-cell
maturation antigen (BCMA) and T cells (via CD3) in a unique 2:1
fashion. This interaction aims to drive myeloma cell death by
inducing T cell activation and release of proinflammatory cytokines
and cytolytic enzymes.
In the ongoing alnuctamab CC-93269-MM-001 open-label, Phase 1
study, 138 patients with relapsed/refractory (R/R) multiple myeloma
were enrolled (as of November 1, 2022) to receive escalating doses
of alnuctamab administered either intravenously (IV) (n=70) or
subcutaneously (SC) (n=68). Intravenous alnuctamab was administered
as previously reported at target doses of 0.15–10 mg, with both
fixed and step-up dosing, while SC alnuctamab was given to patients
in two step-up doses (3 mg and 6 mg) followed by escalating target
doses of 10, 15, 30, and 60 mg, given every one week for three
months, then every two weeks for three months, followed by every
four weeks after those six months.
In interim results, SC alnuctamab (n=68) showed an improved
safety profile compared to IV delivery, with cytokine release
syndrome (CRS) limited to low-grade, short-lived events, allowing
for dose escalation to higher target doses. Intravenous and SC
alnuctamab both exhibited promising pharmacodynamic effects,
triggering the release of the hallmark cytokines of TCEs(e.g., IL-1
and IL-6). However, SC alnuctamab triggered reduced and delayed
cytokine production compared to more potent CRS induced by IV
delivery. Subcutaneous alnuctamab also demonstrated encouraging
dose-dependent anti-tumor activity across all target doses,
particularly in patients who received the 30 mg target dose.
Alnuctamab CC-93269-MM-001
Study
Safety
IV alnuctamab (n=70)
Cytokine Release Syndrome (CRS) – Any
Grade
76% (53/70)
Grade >3
CRS
7% (5/70)
SC alnuctamab (n=68)
CRS – Any Grade
50% (34/68)
Grade >3
CRS
0
Median time to onset of CRS
3 days (range: 1-20)
Median duration of CRS
2 days (range: 1-11)
SC alnuctamab efficacy (n=68)
Overall response rate (ORR)
53% (36/68)
ORR in patient treated with 30 mg dose
65% (44/68)
Median duration of response (DOR)
NR (90% of responses ongoing at
data cut-off)
Minimal residual disease (MRD)-negativity
among patients who achieved a response (n=20 evaluable
patients)
80% (16/20)
GPRC5D CAR T (BMS-986393/CC-95266)
Phase 1 Study Results GPRC5D has been identified as an
orphan receptor that is highly expressed on multiple myeloma cells,
with limited expression in other tissues. BMS-986393 is a
GPRC5D-directed autologous CAR T cell therapy.
This Phase 1, first-in-human, multicenter, open-label study is
evaluating BMS-986393 in patients with R/R multiple myeloma who had
received three or more prior lines of therapy. Prior BCMA-targeted
treatment, including CAR T cell therapy, was allowed. Primary
objectives of the study were to determine safety and tolerability
of BMS-986393 and inform the recommended dose for future
development.
At the time of the interim analysis, BMS-986393 demonstrated a
well-tolerated safety profile with mostly low-grade and short-lived
occurrences of CRS and neurotoxicity across all tested dose levels.
Neurotoxicity was infrequent and low-grade, with no Grade 3 or 4
events reported, and events were reversible with steroid treatment.
All on-target off-tumor adverse events were Grade 1, and the
majority (78.6%) did not require treatment. Preliminary efficacy
also supports the potential of BMS-986393 to elicit deep and
durable responses.
BMS-986393 Phase 1 Study
Safety (n=33)
CRS – Any Grade
63.6% (21/33)
Grade 3/4 CRS
6% (2/33)
Median time to onset CRS
3 days (range: 1-9)
Median duration of CRS
4 days
Neurotoxicity – Grade 1/2
6% (2/33)
Duration of neurotoxicity
1-3 days
On-target off-tumor AEs – Grade 1
30% (10/33)
Dysgeusia/taste disorder
15% (5/33)
Nail disorder
9.1% (3/33)
Dysphagia
3% (1/33)
Efficacy (n=19) Median follow-up:
5.82 months
ORR
89.5% (17/19)
CRR
- CR – Patients treated with prior BCMA-directed CAR T cell
therapies
- CR – Patients treated with prior BCMA-directed therapies
47.4% (9/19) 7 patients 2
patients
Patients treated with prior BCMA-directed
therapies subgroup (n=9)
77.8% (7/9) 44.4% (4/9)
Patients remaining in follow-up
78.9% (15/19)
Abecma® (idecabtagene
vicleucel) KarMMa Phase 2 Cohorts 2a
and 2c Study Results KarMMa-2 (NCT03601078) is a
multi-cohort, open-label, multicenter Phase 2 trial evaluating
Abecma in patients with relapsed and refractory multiple myeloma
(Cohort 1), patients with multiple myeloma who have progressive
disease within 18 months of initial treatment including autologous
stem cell transplant (ASCT) (Cohort 2a), or in patients with
inadequate response following ASCT during initial treatment (Cohort
2c). Based on results from Cohorts 2a and 2c, Abecma demonstrated
complete and durable responses in a significant proportion of
patients, alongside a well-established and predictable safety
profile with mostly low-grade occurrences of CRS and neurotoxicity.
Abecma is being jointly developed and commercialized in the U.S. as
part of a Co-Development, Co-Promotion, and Profit Share Agreement
between Bristol Myers Squibb and 2seventy bio.
Abecma KarMMa-2 Study COHORT 2a
(n=37) Patients with multiple myeloma who had early relapse after
frontline ASCT
Efficacy
CRR (primary efficacy endpoint)
45.9% (95% CI: 29.5-63.1)
ORR
83.8% (95% CI: 68-93.8)
Median DOR
15.7 months (95% CI:
7.6-19.8)
Safety
CRS – Grade 1/2
81.1% (30/37)
CRS – Grade 3
2.7% (1/37)
Neurotoxicity – Grade 1/2
21.6% (8/37)
*Median follow-up – 21.5 months
COHORT 2c (n=31) Patients with
newly diagnosed multiple myeloma who had an inadequate response to
ASCT
Efficacy
CRR
74.2% (95% CI: 55.4-88.1)
ORR
87.1% (95% CI: 70.2-96.4)
Safety
CRS – Grade 1
45.2% (14/31)
CRS – Grade 2
12.9% (4/31)
Neurotoxicity
6.5% (2/31) Grade 1 – 1/31 Grade
3 – 1/31
*Median follow-up – 27.9 months
Novel CELMoD™ agents mezigdomide
(CC-92480) and iberdomide (CC-220) Phase 1/2 Study
Results Cereblon E3 ligase modulators (CELMoD) are a
class of oral immunomodulatory therapeutics that are designed to
stimulate the immune system and directly kill cancer cells by
inducing the degradation of tumor-promoting proteins. Bristol Myers
Squibb is investigating two novel CELMoD agents, mezigdomide and
iberdomide, for multiple myeloma that were intentionally designed
to improve upon the demonstrated efficacy of the IMiD® agents,
along with manageable tolerability, ease of administration, and the
potential to improve patient outcomes. These agents co-opt cereblon
to induce degradation of target proteins Ikaros and Aiolos, which
inhibits tumor cell proliferation, promote tumor cell death, and
induce immune-stimulatory effects.
The mezigdomide CC-92480-MM-001 trial is an ongoing open-label,
international Phase 1/2 study to investigate the safety and
efficacy of mezigdomide in combination with dexamethasone (DEX) in
patients with relapsed/refractory (R/R) multiple myeloma. As part
of the expansion cohort phase, 101 highly refractory patients that
had received three or more prior lines of therapy, including an
IMiD agent, a proteasome inhibitor (PI), and an anti-CD38 mAb, were
given mezigdomide for 21 of 28 days in combination with weekly DEX
at the recommended Phase 2 dose selected in part 1 of the study (1
mg once daily). The primary objective was efficacy as determined by
objective response rate (ORR), while safety, tolerability and
additional efficacy measures were included as the secondary
objectives.
Based on interim results, mezigdomide, in combination with
weekly DEX (40 mg; 20 mg if >75 years of age), showed promising
efficacy in a highly refractory patient population. As of the data
cut-off date, mezigdomide plus DEX showed a manageable safety
profile.
Mezigdomide CC-92489-MM-001
Study
Efficacy
ORR in patients receiving three or more
prior lines of therapy
40.6% (40/101) (n=101)
ORR in patients that had also received
prior BCMA-targeted therapies
50% (15/30) (n=30)
Safety
Grade 3/4 treatment-emergent adverse
events (TEAEs)
89.1% (90/101)
Hematologic TEAEs
- Neutropenia
- Anemia
- Thrombocytopenia
76.2% (77/101)
Mezigdomide dose interruptions and
reductions due to TEAEs
29.7% (30/101)
Treatment discontinuation due to TEAEs
5.9% (6/101)
The iberdomide CC-220-MM-001 study is an ongoing Phase 1/2
multicenter, open-label and multi-cohort trial evaluating orally
administered iberdomide in several combinations and segments of
patients with R/R multiple myeloma. Results at ASH are being
presented from the dose-expansion cohort evaluating iberdomide in
combination with DEX in patients with multiple myeloma who have
heavily-pretreated refractory disease and also received anti-BCMA
therapy.
Iberdomide was given orally, 1.6 mg once daily for 21 of 28
days, plus weekly DEX (40 mg; 20 mg if >75 years of age). The
primary objectives were preliminary efficacy measured by ORR and
safety. Patients treated with iberdomide with DEX demonstrated
meaningful clinical activity, regardless of modality (TCE, CAR T
cell or antibody-drug conjugate therapy), suggesting that
iberdomideretains its activity in these patients.
Iberdomide CC-220-MM-001
Study
Efficacy (n=41)
Overall response rate *As of Sept. 6,
2022
34.1% (13/41)
Safety
Grade 3/4 treatment-emergent adverse
events (TEAEs) *Mostly hematologic, including leukopenia, anemia
and thrombocytopenia
80.5% (33/41)
Iberdomide dose interruptions and
reductions due to TEAEs
63.4% (26/41) 17.1% (7/41)
Treatment discontinuation due to TEAEs
0
Important Safety Information
BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES,
HLH/MAS, AND PROLONGED CYTOPENIA
- Cytokine Release Syndrome (CRS), including fatal or
life-threatening reactions, occurred in patients following
treatment with ABECMA. Do not administer ABECMA to patients with
active infection or inflammatory disorders. Treat severe or
life-threatening CRS with tocilizumab or tocilizumab and
corticosteroids.
- Neurologic Toxicities, which may be severe or life-threatening,
occurred following treatment with ABECMA, including concurrently
with CRS, after CRS resolution, or in the absence of CRS. Monitor
for neurologic events after treatment with ABECMA. Provide
supportive care and/or corticosteroids as needed.
- Hemophagocytic Lymphohistiocytosis/Macrophage Activation
Syndrome (HLH/MAS) including fatal and life-threatening reactions,
occurred in patients following treatment with ABECMA. HLH/MAS can
occur with CRS or neurologic toxicities.
- Prolonged Cytopenia with bleeding and infection, including
fatal outcomes following stem cell transplantation for
hematopoietic recovery, occurred following treatment with
ABECMA.
- ABECMA is available only through a restricted program under a
Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA
REMS.
Cytokine Release Syndrome (CRS): CRS, including fatal or
life-threatening reactions, occurred following treatment with
ABECMA. CRS occurred in 85% (108/127) of patients receiving ABECMA.
Grade 3 or higher CRS (Lee grading system) occurred in 9% (12/127)
of patients, with Grade 5 CRS reported in one (0.8%) patient. The
median time to onset of CRS, any grade, was 1 day (range: 1 - 23
days) and the median duration of CRS was 7 days (range: 1 - 63
days) in all patients including the patient who died. The most
common manifestations of CRS included pyrexia (98%), hypotension
(41%), tachycardia (35%), chills (31%), hypoxia (20%), fatigue
(12%), and headache (10%). Grade 3 or higher events that may be
associated with CRS include hypotension, hypoxia,
hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress
syndrome (ARDS), atrial fibrillation, hepatocellular injury,
metabolic acidosis, pulmonary edema, multiple organ dysfunction
syndrome and HLH/MAS.
Identify CRS based on clinical presentation. Evaluate for and
treat other causes of fever, hypoxia, and hypotension. CRS has been
reported to be associated with findings of HLH/MAS, and the
physiology of the syndromes may overlap. HLH/MAS is a potentially
life-threatening condition. In patients with progressive symptoms
of CRS or refractory CRS despite treatment, evaluate for evidence
of HLH/MAS.
Fifty four percent (68/127) of patients received tocilizumab;
35% (45/127) received a single dose while 18% (23/127) received
more than 1 dose of tocilizumab. Overall, across the dose levels,
15% (19/127) of patients received at least 1 dose of
corticosteroids for treatment of CRS. All patients that received
corticosteroids for CRS received tocilizumab.
Overall rate of CRS was 79% and rate of Grade 2 CRS was 23% in
patients treated in the 300 x 106 CAR+ T cell dose cohort. For
patients treated in the 450 x 106 CAR+ T cell dose cohort, the
overall rate of CRS was 96% and rate of Grade 2 CRS was 40%. Rate
of Grade 3 or higher CRS was similar across the dose range. The
median duration of CRS for the 450 x 106 CAR+ T cell dose cohort
was 7 days (range: 1-63 days) and for the 300 x 106 CAR+ T cell
dose cohort was 6 days (range: 2-28 days). In the 450 x 106 CAR+ T
cell dose cohort, 68% (36/53) of patients received tocilizumab and
23% (12/53) received at least 1 dose of corticosteroids for
treatment of CRS. In the 300 x 106 CAR+ T cell dose cohort, 44%
(31/70) of patients received tocilizumab and 10% (7/70) received
corticosteroids. All patients that received corticosteroids for CRS
also received tocilizumab. Ensure that a minimum of 2 doses of
tocilizumab are available prior to infusion of ABECMA.
Monitor patients at least daily for 7 days following ABECMA
infusion at the REMS-certified healthcare facility for signs and
symptoms of CRS. Monitor patients for signs or symptoms of CRS for
at least 4 weeks after infusion. At the first sign of CRS,
institute treatment with supportive care, tocilizumab and/or
corticosteroids as indicated.
Counsel patients to seek immediate medical attention should
signs or symptoms of CRS occur at any time.
Neurologic Toxicities: Neurologic toxicities, which may
be severe or life-threatening, occurred following treatment with
ABECMA, including concurrently with CRS, after CRS resolution, or
in the absence of CRS. CAR T cell-associated neurotoxicity occurred
in 28% (36/127) of patients receiving ABECMA, including Grade 3 in
4% (5/127) of patients. One patient had ongoing Grade 2
neurotoxicity at the time of death. Two patients had ongoing Grade
1 tremor at the time of data cutoff. The median time to onset of
neurotoxicity was 2 days (range: 1 - 42 days). CAR T
cell-associated neurotoxicity resolved in 92% (33/36) of patients
with a median duration of neurotoxicity was 5 days (range: 1 - 61
days). The median duration of neurotoxicity was 6 days (range: 1 -
578) in all patients including those with ongoing neurotoxicity at
the time of death or data cut off. Thirty-four patients with
neurotoxicity had CRS. Neurotoxicity had onset in 3 patients
before, 29 patients during, and 2 patients after CRS. The rate of
Grade 3 neurotoxicity was 8% in the 450 x 106 CAR+ T cell dose
cohort and 1.4% in the 300 x 106 CAR+ T cell dose cohort. The most
frequently reported (greater than or equal to 5%) manifestations of
CAR T cell-associated neurotoxicity include encephalopathy (20%),
tremor (9%), aphasia (7%), and delirium (6%). Grade 4 neurotoxicity
and cerebral edema in 1 patient has been reported with ABECMA in
another study in multiple myeloma. Grade 3 myelitis and Grade 3
parkinsonism have been reported after treatment with ABECMA in
another study in multiple myeloma.
Monitor patients at least daily for 7 days following ABECMA
infusion at the REMS-certified healthcare facility for signs and
symptoms of neurologic toxicities. Rule out other causes of
neurologic symptoms. Monitor patients for signs or symptoms of
neurologic toxicities for at least 4 weeks after infusion and treat
promptly. Neurologic toxicity should be managed with supportive
care and/or corticosteroids as needed.
Counsel patients to seek immediate medical attention should
signs or symptoms of neurologic toxicity occur at any time.
Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage
Activation Syndrome (MAS): HLH/MAS occurred in 4% (5/127) of
patients receiving ABECMA. One patient treated in the 300 x 106
CAR+ T cell dose cohort developed fatal multi-organ HLH/MAS with
CRS. In another patient with fatal bronchopulmonary aspergillosis,
HLH/MAS was contributory to the fatal outcome. Three cases of Grade
2 HLH/MAS resolved. The rate of HLH/MAS was 8% in the 450 x 106
CAR+ T cell dose cohort and 1% in the 300 x 106 CAR+ T cell dose
cohort. All events of HLH/MAS had onset within 10 days of receiving
ABECMA with a median onset of 7 days (range: 4-9 days) and occurred
in the setting of ongoing or worsening CRS. Two patients with
HLH/MAS had overlapping neurotoxicity. The manifestations of
HLH/MAS include hypotension, hypoxia, multiple organ dysfunction,
renal dysfunction, and cytopenia. HLH/MAS is a potentially
life-threatening condition with a high mortality rate if not
recognized early and treated. Treatment of HLH/MAS should be
administered per institutional standards.
ABECMA REMS: Due to the risk of CRS and neurologic
toxicities, ABECMA is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) called the
ABECMA REMS. Further information is available at www.AbecmaREMS.com
or 1-888-423-5436.
Hypersensitivity Reactions: Allergic reactions may occur
with the infusion of ABECMA. Serious hypersensitivity reactions,
including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in
ABECMA.
Infections: ABECMA should not be administered to patients
with active infections or inflammatory disorders. Severe,
life-threatening, or fatal infections occurred in patients after
ABECMA infusion. Infections (all grades) occurred in 70% of
patients. Grade 3 or 4 infections occurred in 23% of patients.
Overall, 4 patients had Grade 5 infections (3%); 2 patients (1.6%)
had Grade 5 events of pneumonia, 1 patient (0.8%) had Grade 5
bronchopulmonary aspergillosis, and 1 patient (0.8%) had
cytomegalovirus (CMV) pneumonia associated with Pneumocystis
jirovecii. Monitor patients for signs and symptoms of infection
before and after ABECMA infusion and treat appropriately.
Administer prophylactic, preemptive, and/or therapeutic
antimicrobials according to standard institutional guidelines.
Febrile neutropenia was observed in 16% (20/127) of patients
after ABECMA infusion and 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.
Viral Reactivation: Cytomegalovirus (CMV) infection resulting in
pneumonia and death has occurred following ABECMA administration.
Monitor and treat for CMV reactivation in accordance with clinical
guidelines. 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 plasma cells.
Perform screening for CMV, HBV, hepatitis C virus (HCV), and human
immunodeficiency virus (HIV) in accordance with clinical guidelines
before collection of cells for manufacturing.
Prolonged Cytopenias: Patients may exhibit prolonged
cytopenias following lymphodepleting chemotherapy and ABECMA
infusion. In the KarMMa study, 41% of patients (52/127) experienced
prolonged Grade 3 or 4 neutropenia and 49% (62/127) experienced
prolonged Grade 3 or 4 thrombocytopenia that had not resolved by
Month 1 following ABECMA infusion. Rate of prolonged neutropenia
was 49% in the 450 x 106 CAR+ T cell dose cohort and 34% in the 300
x 106 CAR+ T cell dose cohort. In 83% (43/52) of patients who
recovered from Grade 3 or 4 neutropenia after Month 1, the median
time to recovery from ABECMA infusion was 1.9 months. In 65%
(40/62) of patients who recovered from Grade 3 or 4
thrombocytopenia, the median time to recovery was 2.1 months.
Median time to cytopenia recovery was similar across the 300 and
450 x 106 dose cohort.
Three patients underwent stem cell therapy for hematopoietic
reconstitution due to prolonged cytopenia. Two of the three
patients died from complications of prolonged cytopenia. Monitor
blood counts prior to and after ABECMA infusion. Manage cytopenia
with myeloid growth factor and blood product transfusion support
according to institutional guidelines.
Hypogammaglobulinemia: Plasma cell aplasia and
hypogammaglobulinemia can occur in patients receiving treatment
with ABECMA. Hypogammaglobulinemia was reported as an adverse event
in 21% (27/127) of patients; laboratory IgG levels fell below 500
mg/dl after infusion in 25% (32/127) of patients treated with
ABECMA.
Monitor immunoglobulin levels after treatment with ABECMA and
administer IVIG for IgG <400 mg/dl. Manage per local
institutional guidelines, including infection precautions and
antibiotic or antiviral prophylaxis.
The safety of immunization with live viral vaccines during or
following ABECMA 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 ABECMA
treatment, and until immune recovery following treatment with
ABECMA.
Secondary Malignancies: Patients treated with ABECMA may
develop secondary malignancies. Monitor life-long for secondary
malignancies. If a secondary malignancy occurs, contact Bristol
Myers Squibb at 1-888-805-4555 to obtain instructions on patient
samples to collect for testing of secondary malignancy of T cell
origin.
Effects on Ability to Drive and Operate Machinery: Due to
the potential for neurologic events, including altered mental
status or seizures, patients receiving ABECMA are at risk for
altered or decreased consciousness or coordination in the 8 weeks
following ABECMA infusion. Advise patients to refrain from driving
and engaging in hazardous occupations or activities, such as
operating heavy or potentially dangerous machinery, during this
initial period.
Adverse Reactions: The most common nonlaboratory adverse
reactions (incidence greater than or equal to 20%) include CRS,
infections – pathogen unspecified, fatigue, musculoskeletal pain,
hypogammaglobulinemia, diarrhea, upper respiratory tract infection,
nausea, viral infections, encephalopathy, edema, pyrexia, cough,
headache, and decreased appetite.
Please see full Prescribing Information, including Boxed
WARNINGS and Medication Guide.
Bristol Myers Squibb: Transforming the
Multiple Myeloma Treatment Paradigm At BMS, we believe
that every patient deserves a tailored treatment approach to
achieve the best possible outcome for their disease, from extended
survival and reduced treatment burden to the possibility of cure.
Over two decades of trailblazing work in multiple myeloma, we have
driven significant scientific and clinical advancements. As we look
forward, we are leveraging our deep immunotherapy experience to
progress an industry-leading pipeline across targets, molecular
approaches and combinations (including BCMA-targeted therapies,
targeted protein degradation, CAR T cell therapies and NK-cell
engagers). Understanding that continued partnership with the
multiple myeloma community is key to advancing scientific progress,
we pride ourselves on an openness to collaborate, which is
reflected in our ongoing research fueled by academic and industry
partnerships. While multiple myeloma remains a relentless disease,
we continue to transform the multiple myeloma treatment paradigm by
dramatically improving outcomes for every patient.
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Future for Cancer Patients 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
scientific expertise, cutting-edge capabilities and discovery
platforms enable the company to look at 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.
Because 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
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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 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,
that future study results will be consistent with the results to
date, that the product candidates described in this release may not
receive regulatory approval for the indications described in this
release and, if approved, whether such product candidates for such
indications 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, 2021, 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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