The Phase 3 ACTIV-1 Immune Modulators study
was sponsored by the National Institutes of Health as part of the
ACTIV initiative
Orencia was one of two immune modulators
that improved survival for people hospitalized with
COVID-19
Safety profile of Orencia remained
consistent, with no new safety signals reported
Bristol Myers Squibb (NYSE: BMY) today announced topline results
from the Phase 3 Accelerating COVID-19 Therapeutic Interventions
and Vaccines (ACTIV-1) Immune Modulators clinical trial, sponsored
by the National Institutes of Health (NIH). The study evaluated the
safety and efficacy of a single dose of immune modulators,
including Orencia (abatacept) IV (10 mg/kg) versus placebo when
given with standard of care to determine if modulating the immune
system’s response could speed recovery and reduce death in adults
hospitalized with moderate to severe COVID-19.
Treatment with Orencia versus placebo displayed a strong but not
statistically significant improvement in the primary endpoint of
time to recovery as measured by day of hospital discharge. Analyses
of the secondary endpoints, which included mortality and clinical
status, demonstrated Orencia reduced participants’ risk of death
and improved their clinical status at 28 days after entering the
study when compared with placebo. The risk of death was lower for
participants who received Orencia at 11%, versus 15% for those who
received placebo, and the odds of dying were 37.4% lower. The
relative improvement in mortality was similar in both moderately
and severely ill participants. People in the Orencia group had
34.2% better odds of clinical improvement than those in the placebo
group. The safety profile of Orencia remained consistent, with no
new safety signals reported in the study.
“With the continued need across the globe for treatment options
to address the threat of COVID-19, we are proud of our involvement
in the ACTIV-1 Immune Modulators clinical trial and our scientific
research related to the virus. The devastating resurgences
associated with circulating and emerging COVID variants underscore
the need for additional therapeutic options for those who are
hospitalized with COVID-19,” said Samit Hirawat, MD, chief medical
officer, Bristol Myers Squibb. “We are pleased with the data
demonstrating the risk of death was lower for participants who
received Orencia and look forward to continued collaboration with
the NIH to assess the data and potentially bring this treatment
option to those in need.”
The full report on these data will be published in a
peer-reviewed scientific journal. Given the positive findings from
the topline data, Bristol Myers Squibb plans to discuss these data
and potential next steps with the U.S. Food and Drug
Administration.
About ORENCIA
ORENCIA® is a selective costimulation modulator that disrupts
the continuous cycle of T-cell activation.
U.S. Indications/Usage and Important Safety Information for
ORENCIA® (abatacept)
Indications and Usage
Adult Rheumatoid Arthritis: ORENCIA® (abatacept) is
indicated for the treatment of adult patients with moderately to
severely active rheumatoid arthritis (RA).
Polyarticular Juvenile Idiopathic Arthritis: ORENCIA is
indicated for the treatment of patients 2 years of age and older
with moderately to severely active polyarticular juvenile
idiopathic arthritis (pJIA).
Adult Psoriatic Arthritis: ORENCIA is indicated for the
treatment of adult patients with active psoriatic arthritis
(PsA).
Prophylaxis for Acute Graft versus Host Disease: ORENCIA
is indicated for the prophylaxis of acute graft versus host disease
(aGVHD), in combination with a calcineurin inhibitor and
methotrexate, in adults and pediatric patients 2 years of age or
older undergoing hematopoietic stem cell transplantation (HSCT)
from a matched or 1 allele-mismatched unrelated-donor.
Limitations of Use: The concomitant use of ORENCIA with
other potent immunosuppressants [e.g., biologic disease-modifying
antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is
not recommended.
Important Safety Information for ORENCIA® (abatacept)
Increased Risk of Infection with Concomitant Use with TNF
Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors:
Concurrent therapy with ORENCIA and a TNF antagonist is not
recommended. In controlled clinical trials, adult RA patients
receiving concomitant intravenous ORENCIA and TNF antagonist
therapy experienced more infections (63% vs 43%) and serious
infections (4.4% vs 0.8%) compared to patients treated with only
TNF antagonists, without an important enhancement of efficacy.
Additionally, concomitant use of ORENCIA with other biologic RA/PsA
therapy or JAK inhibitors is not recommended.
Hypersensitivity: There were 2 cases (<0.1%; n=2688)
of anaphylaxis reactions in clinical trials with adult RA patients
treated with intravenous ORENCIA. Other reactions potentially
associated with drug hypersensitivity, such as hypotension,
urticaria, and dyspnea, each occurred in <0.9% of patients.
There was one case of a hypersensitivity reaction with ORENCIA in
pJIA clinical trials (0.5%; n=190). In postmarketing experience,
fatal anaphylaxis following the first infusion of ORENCIA and
life-threatening cases of angioedema have been reported. Angioedema
has occurred as early as after the first dose of ORENCIA, but also
has occurred with subsequent doses. Angioedema reactions have
occurred within hours of administration and in some instances had a
delayed onset (i.e., days). Appropriate medical support measures
for treating hypersensitivity reactions should be available for
immediate use. If an anaphylactic or other serious allergic
reaction occurs, administration of intravenous or subcutaneous
ORENCIA should be stopped immediately and permanently discontinued,
with appropriate therapy instituted.
Infections: Serious infections, including sepsis and
pneumonia, were reported in 3% and 1.9% of RA patients treated with
intravenous ORENCIA and placebo, respectively. Some of these
infections have been fatal. Many of the serious infections have
occurred in patients on concomitant immunosuppressive therapy
which, in addition to their underlying disease, could further
predispose them to infection. Caution should be exercised in
patients with a history of infection or underlying conditions which
may predispose them to infections. Treatment with ORENCIA should be
discontinued if a patient develops a serious infection. Patients
should be screened for tuberculosis and viral hepatitis in
accordance with published guidelines, and if positive, treated
according to standard medical practice prior to therapy with
ORENCIA.
Immunizations: Prior to initiating ORENCIA in pediatric
and adult patients, update vaccinations in accordance with current
vaccination guidelines. Live vaccines should not be given
concurrently with ORENCIA or within 3 months after discontinuation.
ORENCIA may blunt the effectiveness of some immunizations. In
addition, it is unknown if the immune response of an infant who was
exposed in utero to abatacept and subsequently administered a live
vaccine is impacted. Risks and benefits should be considered prior
to vaccinating such infants.
Increased Risk of Adverse Reactions When Used in Patients
with Chronic Obstructive Pulmonary Disease (COPD): In Study V,
adult COPD patients treated with ORENCIA for RA developed adverse
events more frequently than those treated with placebo, including
COPD exacerbations, cough, rhonchi, and dyspnea. In the study, 97%
of COPD patients treated with ORENCIA developed adverse events
versus 88% treated with placebo. Respiratory disorders occurred
more frequently in patients treated with ORENCIA compared to those
on placebo (43% vs 24%, respectively), including COPD exacerbation,
cough, rhonchi, and dyspnea. A greater percentage of patients
treated with ORENCIA developed a serious adverse event compared to
those on placebo (27% vs 6%), including COPD exacerbation [3 of 37
patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of
ORENCIA in patients with COPD should be undertaken with caution,
and such patients monitored for worsening of their respiratory
status.
Immunosuppression: In clinical trials in adult RA
patients, a higher rate of infections was seen in ORENCIA-treated
patients compared to placebo-treated patients. The impact of
treatment with ORENCIA on the development and course of
malignancies is not fully understood. There have been reports of
malignancies, including skin cancer in patients receiving ORENCIA.
Periodic skin examinations are recommended for all ORENCIA-treated
patients, particularly those with risk factors for skin cancer.
Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
Reactivation in aGVHD Prophylaxis after Hematopoietic Stem Cell
Transplant (HSCT): Post-Transplant Lymphoproliferative Disorder
(PTLD) occurred in patients who received ORENCIA for aGVHD
prophylaxis during unrelated HSCT. Of 116 patients who received
ORENCIA, 4 patients (3.4%) experienced PTLD. All the PTLD events
were associated with Epstein-Barr virus (EBV) infection. The range
of time to onset of the event was 49 to 89 days post-transplant.
Monitor patients for EBV reactivation in accordance with
institutional practices. Before administering Orencia, provide
recommended prophylaxis for EBV infection and continue for 6 months
post-transplantation to prevent EBV-associated PTLD.
Cytomegalovirus (CMV) invasive disease occurred in patients who
received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of
116 patients who received ORENCIA, 7% (n=8) experienced CMV
invasive diseases up to day 225 post-transplant. The median time to
onset of the event was 91 days post-transplant. CMV invasive
diseases predominantly involved the gastrointestinal tract. Monitor
patients for CMV infection/reactivation for 6 months
post-transplant regardless of the results of donor and recipient
pre-transplant CMV serology. Consider prophylaxis for CMV
infection/reactivation during treatment and for six months
following HSCT.
Blood Glucose Testing: ORENCIA for intravenous
administration contains maltose, which may result in falsely
elevated blood glucose readings on the day of infusion when using
blood glucose monitors with test strips utilizing glucose
dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using
monitors and advising patients to use monitors that do not react
with maltose, such as those based on glucose dehydrogenase nicotine
adenine dinucleotide (GDH-NAD), glucose oxidase or glucose
hexokinase test methods. ORENCIA for subcutaneous (SC)
administration does not contain maltose; therefore, patients do not
need to alter their glucose monitoring.
Pregnancy: There are no adequate and well-controlled
studies of ORENCIA use in pregnant women and the data with ORENCIA
use in pregnant women are insufficient to inform on drug-associated
risk. A pregnancy registry has been established to monitor
pregnancy outcomes in women exposed to ORENCIA during pregnancy.
Healthcare professionals are encouraged to register patients by
calling 1-877-311-8972.
Lactation: There is no information regarding the presence
of abatacept in human milk, the effects on the breastfed infant, or
the effects on milk production. However, abatacept was present in
the milk of lactating rats dosed with abatacept.
Most Serious Adverse Reactions: In controlled clinical
trials, adult RA patients experienced serious infections (3%
ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1%
placebo). In the GVHD-1 study, serious adverse reactions reported
in >5% of patients who received ORENCIA in combination with a
calcineurin inhibitor and methotrexate and >2% higher than
placebo included pyrexia (20%), pneumonia (8%), acute kidney injury
(7%), diarrhea (6%), hypoxia (5%), and nausea (5%).
Malignancies: The overall frequency of malignancies was
similar between adult RA patients treated with ORENCIA or placebo.
However, more cases of lung cancer were observed in patients
treated with ORENCIA (0.2%) than those on placebo (0%). A higher
rate of lymphoma was seen compared to the general population;
however, patients with RA, particularly those with highly active
disease, are at a higher risk for the development of lymphoma. The
potential role of ORENCIA in the development of malignancies in
humans is unknown.
Most Frequent Adverse Events (≥10%): Headache, upper
respiratory tract infection, nasopharyngitis, and nausea were the
most commonly reported adverse events in the adult RA clinical
studies. Other events reported in ≥5% of pJIA patients were
diarrhea, cough, pyrexia, and abdominal pain. In general, the
adverse events in pediatric pJIA and adult PsA patients were
similar in frequency and type to those seen in adult RA patients.
The most frequent adverse reactions of all grades reported in ≥10%
of patients with aGVHD who received ORENCIA with a difference of
≥2% for the 7/8 cohort, 8/8 cohort Orencia arm, and 8/8 cohort
placebo arm, respectively, were anemia (56%, 69%, and 57%), CD4
lymphocytes decreased (14%, 14%, and 9%), hypertension (49%, 43%,
and 38%), pyrexia (28%, 19%, and 20%), CMV reactivation/CMV
infection (26%, 32%, and 22%), pneumonia (19%, 12%, and 10%),
epistaxis (12%, 16%, and 10%), acute kidney injury (9%, 15%, and
10%), and hypermagnesemia (5%, 18%, 10%).
Incidence rates of grade 3 or 4 adverse reactions were the same
as incidence rates of all grades, with the exception of grade 3 or
4 pyrexia in all arms (9% [7/8 cohort], 10% [8/8 cohort, Orencia
arm], and 4% [8/8 cohort, placebo arm]), pneumonia in the 8/8
cohort placebo arm (9%) and acute kidney injury in the 7/8 cohort
Orencia arm (7%). Clinically relevant adverse reactions in <10%
of patients who received ORENCIA in combination with calcineurin
inhibitor and methotrexate in Study GVHD-1 included EBV
reactivation.
Note concerning ORENCIA administration options: ORENCIA
may be administered as an intravenous infusion only for patients 6
years of age and older. PJIA patients may self-inject with ORENCIA
or the patient’s caregiver may administer ORENCIA if both the
healthcare practitioner and the parent/legal guardian determines it
is appropriate. The ability of pediatric patients to self-inject
with the autoinjector has not been tested. ORENCIA may only be
administered as an intravenous (IV) infusion for the prophylaxis of
aGVHD in patients undergoing HSCT. The safety and effectiveness of
ORENCIA have not been established in pediatric patients younger
than 2 years of age for prophylaxis of aGVHD.
Please click here for Full Prescribing Information.
Bristol Myers Squibb: Pioneering Paths Forward in Immunology
to Transform Patients’ Lives
Bristol Myers Squibb is inspired by a single vision –
transforming patients’ lives through science. For people living
with immune-mediated diseases, the debilitating reality of enduring
chronic symptoms and disease progression can take a toll on their
physical, emotional and social well-being, making simple tasks and
daily life a challenge. Driven by our deep understanding of the
immune system that spans over 20 years of experience, and our
passion to help patients, the company continues to pursue
pathbreaking science with the goal of delivering meaningful
solutions that address unmet needs in rheumatology,
gastroenterology, dermatology and neurology. We follow the science,
aiming to tailor therapies to individual needs, improve outcomes
and expand treatment options by working to identify mechanisms with
the potential to achieve long-term remission – and perhaps even
cures – in the future. By building partnerships with researchers,
patients and caregivers to deliver innovative treatments, Bristol
Myers Squibb strives to elevate patient care to new standards and
deliver what matters most – the promise of living a better
life.
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.
Celgene and Juno Therapeutics are wholly owned subsidiaries of
Bristol-Myers Squibb Company. In certain countries outside the
U.S., due to local laws, Celgene and Juno Therapeutics are referred
to as, Celgene, a Bristol Myers Squibb company and Juno
Therapeutics, a Bristol Myers Squibb company.
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 Orencia (abatacept), in combination with standard of
care, may not achieve regulatory approval for the additional
indication described in this press release in the currently
anticipated timeline or at all, any marketing approvals, if
granted, may have significant limitations on their use, and if
approved, whether such treatment 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,
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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