At median follow-up of more than 30 months,
Abecma maintained a 51% reduction in risk of disease progression or
death with median PFS of 13.8 months compared with 4.4 months for
standard regimens
Responses were significantly improved with
Abecma and continued to deepen over time with a complete response
rate of 44% vs. 5% for standard regimens with consistent benefit
observed across subgroups
In the KarMMa-3 study, the well-established
safety profile of Abecma remained consistent with generally
predictable and mostly low-grade occurrences of cytokine release
syndrome and neurotoxicity
In newly-diagnosed multiple myeloma, Abecma
demonstrated deep and durable responses with a 77% complete
response rate and median PFS not reached with no new safety signals
with extended follow-up from the KarMMa-2 study
Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq:
TSVT) today announced results from the preplanned final
progression-free survival (PFS) analysis of KarMMa-3, the pivotal
Phase 3, open-label, global, randomized controlled study evaluating
Abecma (idecabtagene vicleucel) compared with standard combination
regimens in adults with relapsed and refractory multiple myeloma
after two to four prior lines of therapy, including an
immunomodulatory agent, a proteasome inhibitor, and an anti-CD38
monoclonal antibody (triple-class exposed), who were refractory to
their last regimen. At a median follow-up of 30.9 months (range:
12.7-47.8), representing the longest follow-up for a randomized
Phase 3 CAR T cell therapy trial in this patient population,
significantly improved PFS was maintained with Abecma compared to
standard regimens (95% CI: 13.8 months vs. 4.4 months), with a 51%
reduction in the risk of disease progression or death (HR: 0.49;
95% CI: 0.38-0.63). These data are being presented today in an oral
presentation at the 65th American Society of Hematology (ASH)
Annual Meeting and Exposition (Oral Presentation #1028).
With extended follow-up, treatment with Abecma (n=254) continued
to demonstrate higher overall response rates (ORR) and a deepening
of responses versus standard regimens. The ORR with Abecma was 71%
(95% CI: 66-77) with a complete response (CR) rate of 44% (95% CI:
38-50), which increased by 5% from the interim analysis. In
comparison, the ORR for standard regimens was 41% (95% CI: 34-51),
with a CR rate of 5% (95% CI: 2-9), which remained unchanged from
the time of interim analysis. The PFS, ORR and CR rates observed in
the KarMMa-3 trial in the standard regimens arm are consistent with
those that have historically been observed in this heavily
pre-treated triple-class exposed patient population, in which PFS
is approximately four months and deep and durable responses are
limited. With these data, Abecma is the first and only anti-BCMA
CAR T cell therapy to demonstrate superiority over standard
regimens in a randomized, controlled Phase 3 trial designed to
evaluate patients with triple-class exposed relapsed and refractory
multiple myeloma.
“With longer follow-up from the KarMMa-3 study, we continue to
see the significant clinical benefit that Abecma delivers for
triple-class exposed multiple myeloma, illustrating the potential
of using Abecma for long-term disease control and remission when
used earlier in the treatment paradigm,” said Paula
Rodriguez-Otero, M.D., Ph.D., Department of Hematology, Clinica
Universidad de Navarra, Pamplona, Spain. “As the CAR T therapy with
the longest real-world experience in later lines of therapy, and
with these latest data which demonstrate clinically meaningful
benefit and a well-established and generally predictable safety
profile, Abecma has the potential to be a transformative treatment
option across lines of therapy for triple-class exposed relapsed
and refractory multiple myeloma.”
“As the first-in-class anti-BCMA CAR T cell therapy, we have
long believed in the clinical value Abecma can deliver across the
treatment paradigm for multiple myeloma, transforming outcomes for
patients with a relentless disease and continued unmet need,” said
Anne Kerber, senior vice president, Head of Late Clinical
Development, Hematology, Oncology, and Cell Therapy, Bristol Myers
Squibb. “These longer-term results from the KarMMa-3 trial clearly
demonstrate the potential of Abecma to be an important treatment
option to provide improved progression-free survival and durable
responses in patients with relapsed and refractory multiple myeloma
after being treated with the three main classes of therapy. We are
proud to share these data which further advance the use of cell
therapies as a new standard of care for more patients in earlier
lines of therapy for difficult-to-treat blood cancers.”
In the study, which included a patient-centric design that
allowed for crossover from standard regimens to Abecma upon
confirmed disease progression, overall survival (OS) was a key
secondary endpoint. Due to the median PFS observed with standard
regimens, more than half (56%) of patients in the standard regimens
arm crossed over to receive Abecma as a subsequent therapy. The
median OS was 41.4 months with Abecma (95% CI: 30.9-NR) and 37.9
months with standard regimens (95% CI: 23.4-NR) (95% CI: 0.73-1.40;
HR: 1.01). However, the prespecified sensitivity analyses adjusting
for crossover showed a median OS of 41.4 months for Abecma (95% CI:
30.9-NR) and 23.4 months (95% CI: 17.9-NR) for standard regimens
(95% CI: 0.45-1.09; HR: 0.69), suggesting a positive trend in OS
benefit for Abecma compared with standard regimens. Historically,
based on real-world evidence, median OS for patients with
triple-class exposed relapsed and refractory multiple myeloma is
approximately 13 months.
“With the adjustments for crossover in the KarMMa-3 study, we
clearly see the consistent trend in survival benefit that this
anti-BCMA CAR T cell therapy delivers, introducing the potential
for Abecma to be an important treatment option for these patients,”
said Sergio Giralt, M.D., Division of Hematologic Malignancies,
Memorial Sloan Kettering Cancer Center. “These results show
remarkable and significantly improved durable outcomes for
relapsing triple-class exposed multiple myeloma patients, which is
a population that has had poor overall and progression-free
survival and no established standard treatment approach that
provides durable responses.”
“It’s important to bear in mind that management of relapsed
refractory multiple myeloma remains challenging; patients are
becoming triple-class exposed earlier in their treatment course and
then developing disease that is resistant to existing therapies,”
said Steve Bernstein, M.D., chief medical officer, 2seventy bio.
“We are excited that these positive results from the KarMMa-3 study
demonstrate a significant clinical benefit of Abecma across lines
of care in triple-class exposed multiple myeloma and look forward
to the potential of expanding the benefits of Abecma to these
patients earlier in their treatment course.”
In the KarMMa-3 study, Abecma continued to exhibit a
well-established and generally predictable safety profile,
including no new safety signals, with mostly low-grade occurrences
of cytokine release syndrome (CRS) and neurotoxicity. In patients
treated with Abecma with extended follow-up, occurrences of CRS and
neurologic toxicities remained consistent with the interim analysis
with 88% of patients experiencing any grade CRS, and Grade 3/4 CRS
events occurring in 4% of patients. Two patients (1%) experienced a
Grade 5 CRS event. Any grade neurotoxicity occurred in 15% of
patients, with Grade 3/4 neurotoxicity occurring in 3% of patients,
and no Grade 5 events reported.
Abecma was recently approved in Japan for patients with relapsed
or refractory multiple myeloma who have received at least two prior
therapies, including an immunomodulatory agent, a proteasome
inhibitor, and an anti-CD38 antibody based on the KarMMa-3 study,
making it the first CAR T to receive regulatory approval for use in
earlier lines of therapy for patients with relapsed or refractory
multiple myeloma. A supplemental Biologics License Application for
Abecma based on the KarMMa-3 results is currently under review with
the U.S. Food and Drug Administration (FDA), and an Oncologic Drugs
Advisory Committee meeting will be held to discuss the data.
Regulatory applications for Abecma in earlier lines of therapy for
triple-class exposed relapsed and refractory multiple myeloma are
also under review with the European Medicines Agency and
Swissmedic.
Results from Extended Follow-up for
Cohort 2c of the KarMMa-2 Study
Results from extended follow-up for Cohort 2c of the
multicohort, Phase 2, multicenter KarMMa-2 study, evaluating Abecma
in patients with multiple myeloma who had an inadequate response to
frontline therapy with autologous stem cell transplantation (ASCT)
are also being presented in a poster presentation (Poster
Presentation #2101) at the meeting. At data cutoff with a median
follow-up of 39.4 months, the ORR in patients treated with Abecma
(n=31) was 87.1% (95% CI: 70.2-96.4), with a CR rate of 77.4% (95%
CI: 58.9-90.4). Median duration of response, median PFS and median
OS were not reached, and all patients who received Abecma (n=31)
remained alive at follow-up. Safety results were generally
consistent with the well-established known safety profile of
Abecma, with any grade CRS occurring in 58.1% of patients and no
reports of Grade >3 CRS.
Abecma is the first-in-class B-cell maturation antigen
(BCMA)-directed CAR T cell immunotherapy approved by the FDA for
the treatment of adult patients with relapsed or refractory
multiple myeloma after four or more prior lines of therapy,
including an immunomodulatory agent, a proteasome inhibitor, and an
anti-CD38 monoclonal antibody. Please see the Important Safety
Information section below, including Boxed WARNINGS for Abecma
regarding CRS, neurologic toxicities, Hemophagocytic
Lymphohistiocytosis/Macrophage Activation Syndrome and Prolonged
Cytopenia. Abecma is also approved in the European Union,
Switzerland, Canada, the United Kingdom and Israel for adult
patients with triple-class exposed relapsed or refractory multiple
myeloma after three to four or more prior lines of therapy.
Memorial Sloan Kettering Cancer Center disclosures: Dr. Giralt
and Memorial Sloan Kettering Cancer Center have financial interests
associated with the research described in this release.
About KarMMa-3
KarMMa-3 (NCT03651128) is a pivotal, Phase 3, open-label,
global, randomized, controlled trial evaluating Abecma compared to
standard regimens in patients with relapsed and refractory multiple
myeloma who have received two to four prior lines of treatment,
including an immunomodulatory agent, a proteasome inhibitor, and an
anti-CD38 monoclonal antibody, and were refractory to the last
treatment regimen. Patients were randomized to receive Abecma or
standard regimens that consisted of combinations that included
daratumumab, pomalidomide, and dexamethasone (DPd), daratumumab,
bortezomib, and dexamethasone (DVd), ixazomib, lenalidomide, and
dexamethasone (IRd), carfilzomib and dexamethasone (Kd) or
elotuzumab, pomalidomide and dexamethasone (EPd) chosen based on
their most recent treatment regimen and investigator discretion.
The primary endpoint evaluated in this study is progression-free
survival (PFS), defined as time from randomization to the first
documentation of progressive disease or death due to any cause,
whichever occurs first. Key secondary endpoints include overall
response rate (ORR) and overall survival (OS).
About KarMMa-2
KarMMa-2 (NCT03601078) is a Phase 2, open-label, multicohort,
multicenter study evaluating the efficacy and safety of Abecma in
patients with relapsed and refractory multiple myeloma (Cohort 1),
patients with multiple myeloma that has progressed within 18 months
of initial treatment including autologous stem cell transplantation
(ASCT) (Cohort 2a), or without ASCT (Cohort 2b) or, in patients
with inadequate response post-ASCT during initial treatment (Cohort
2c), and patients with newly diagnosed multiple myeloma with
suboptimal response to ASCT (Cohort 3). The primary endpoints
evaluated in this study are ORR in Cohort 1 and complete response
(CR) rate in Cohorts 2a, b, c and Cohort 3. Key secondary endpoints
include CR rate in Cohort 1, ORR in Cohorts 2a, b, c and Cohort 3,
duration of response, PFS and OS.
About Abecma
Abecma recognizes and binds to BCMA on the surface of multiple
myeloma cells leading to CAR T cell proliferation, cytokine
secretion, and subsequent cytolytic killing of BCMA-expressing
cells. 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.
The companies’ broad clinical development program for Abecma
includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-9) in earlier
lines of treatment for patients with multiple myeloma. For more
information visit clinicaltrials.gov.
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
WARNINGS AND PRECAUTIONS:
Cytokine Release Syndrome (CRS): CRS, including fatal or
life-threatening reactions, occurred following treatment with
ABECMA in 85% (108/127) of patients. Grade 3 or higher CRS 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). The most common manifestations included
pyrexia, hypotension, tachycardia, chills, hypoxia, fatigue, and
headache. 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. 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
(single dose: 35%; more than 1 dose: 18%). Overall, 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. 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 or
symptoms of CRS and monitor patients for signs or symptoms of CRS
for at least 4 weeks after ABECMA 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 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 time to resolution of 5 days (range: 1 - 61 days).
The median duration of neurotoxicity was 6 days (range: 1 - 578) in
all patients including 3 patients with ongoing neurotoxicity.
Thirty-four patients with neurotoxicity had CRS with onset in 3
patients before, 29 patients during, and 2 patients after CRS. The
most frequently reported manifestations of CAR T cell-associated
neurotoxicity include encephalopathy, tremor, aphasia, and
delirium. Grade 4 neurotoxicity and cerebral edema in 1 patient,
Grade 3 myelitis, and Grade 3 parkinsonism have been reported 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 or
symptoms of neurologic toxicities and monitor patients for signs or
symptoms of neurologic toxicities for at least 4 weeks after ABECMA
infusion and treat promptly. Rule out other causes of neurologic
symptoms. Neurologic toxicity should be managed with supportive
care and/or corticosteroids as needed.
Counsel patients to seek immediate medical attention should
signs or symptoms occur at any time.
Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage
Activation Syndrome (MAS): HLH/MAS occurred in 4% (5/127) of
patients receiving ABECMA. One patient developed fatal multi-organ
HLH/MAS with CRS and another patient developed fatal
bronchopulmonary aspergillosis with contributory HLH/MAS. Three
cases of Grade 2 HLH/MAS resolved. 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
guidelines.
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, pre-emptive, 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.
Viral Reactivation: 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: In the clinical 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. 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.
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.
Hypogammaglobulinemia: 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 appropriately per
local institutional guidelines, including infection precautions and
antibiotic or antiviral prophylaxis.
The safety of immunization with live viral vaccines during or
after 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, 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 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: 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.
Learn more about the science behind cell therapy and ongoing
research at Bristol Myers Squibb here.
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.
About 2seventy bio
Our name, 2seventy bio, reflects why we do what we do - TIME.
Cancer rips time away, and our goal is to work at the maximum speed
of translating human thought into action – 270 miles per hour – to
give the people we serve more time. We are building the leading
immuno-oncology cell therapy company, focused on discovering and
developing new therapies that truly disrupt the cancer treatment
landscape. With a deep understanding of the human body’s immune
response to tumor cells and how to translate cell therapies into
practice, we’re applying this knowledge to deliver next generation
cellular therapies that focus on a broad range of hematologic
malignancies, including the first FDA-approved CAR T cell therapy
for multiple myeloma, as well as solid tumors. Our research and
development is focused on delivering therapies that are designed
with the goal to “think” smarter and faster than the disease.
Importantly, we remain focused on accomplishing these goals by
staying genuine and authentic to our “why” and keeping our people
and culture top of mind every day.
For more information, visit www.2seventybio.com.
Follow 2seventy bio on social media: Twitter and LinkedIn.
2seventy bio is a trademark of 2seventy bio, Inc.
Bristol Myers Squibb 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,
that future study results may not be consistent with the results to
date, that Abecma® (idecabtagene vicleucel), may not receive
regulatory approval for the additional indication described in this
release in the currently anticipated timeline or at all, that any
marketing approvals, if granted, may have significant limitations
on their use, and, if approved, whether such product candidate for
such additional indication 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, 2022, 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.
2seventy bio Cautionary Note 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 Abecma® (idecabtagene vicleucel). 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 that Abecma
may not receive FDA approval for the indication described in this
release in the currently anticipated timeline or at all, that any
marketing approvals, if granted, may have significant limitations
on their use, that Abecma may not be commercially successful and
that collaboration with Bristol Myers Squibb may not continue or be
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 2seventy bio’s business, particularly those identified in
the risk factors discussion in 2seventy bio’s Annual Report on Form
10-K, 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, 2seventy bio
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.
Hyperlinks are provided as a convenience and for informational
purposes only. Neither Bristol Myers Squibb nor 2seventy bio bears
responsibility for the security or content of external websites or
websites outside of their respective control.
corporatefinancial-news
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231210772382/en/
Bristol Myers Squibb
Media Inquiries: media@bms.com
Investors: investor.relations@bms.com
2seventy bio
Media: Jenn Snyder 617-448-0281
jenn.snyder@2seventybio.com
Investors: Elizabeth Pingpank 860-463-0469
elizabeth.pingpank@2seventybio.com
2seventy bio (NASDAQ:TSVT)
Historical Stock Chart
From Jan 2025 to Feb 2025
2seventy bio (NASDAQ:TSVT)
Historical Stock Chart
From Feb 2024 to Feb 2025
