POETYK PSO long-term extension trial results
show maintenance of efficacy response through up to two years of
treatment
Results add to the growing body of evidence
on deucravacitinib, a potential new oral treatment option for
moderate to severe plaque psoriasis
Deucravacitinib is currently under
regulatory review in multiple regions, including the U.S., Europe
and Japan, and would be the first selective allosteric tyrosine
kinase 2 (TYK2) inhibitor approved for the treatment of any
disease
Bristol Myers Squibb (NYSE: BMY) today announced two-year
results from the POETYK PSO long-term extension (LTE) trial
demonstrating durable efficacy and a consistent safety profile with
deucravacitinib treatment in adult patients with moderate to severe
plaque psoriasis. Clinical efficacy was maintained through up to
two years of deucravacitinib treatment, with response rates at Week
60 in the LTE of 77.7% and 58.7% for Psoriasis Area and Severity
Index (PASI) 75 and static Physicians Global Assessment (sPGA) 0/1
(clear/almost clear skin), respectively.
These data (Presentation #133) are being presented at the
European Academy of Dermatology and Venereology (EADV) Spring
Symposium, taking place May 12-14, 2022.
“Plaque psoriasis is a chronic, systemic immune-mediated disease
associated with multiple serious comorbidities, and there remains a
strong unmet need for new treatments, particularly oral medicines,
as many patients are undertreated or are dissatisfied with current
options,” said Professor Richard B. Warren, Consultant
Dermatologist, Salford Royal Hospital, part of Northern Care
Alliance NHS Foundation Trust and Professor at The University of
Manchester. “Long-term research showing durable efficacy, in
addition to a well understood safety profile, is critical for
clinicians and patients making treatment decisions, and these new
two-year data underscore the potential of deucravacitinib to be an
important new oral treatment option for people living with moderate
to severe plaque psoriasis who require systemic therapy.”
The overall safety profile of deucravacitinib observed through
two years spans 2,482 patient years of treatment and was consistent
with that observed in the previously presented pivotal Phase 3
POETYK PSO-1 and POETYK PSO-2 trials. Adverse events (AEs)
continued to be predominantly of mild or moderate severity, with
the most common AEs continuing to be nasopharyngitis, upper
respiratory tract infection and headache. Serious AEs and AEs
leading to discontinuation remained low for up to two years, and no
emerging safety signals were observed. With additional follow-up in
the LTE trial, which coincided with the peak of the COVID-19
pandemic, there was an increased number of reported COVID-19
infections compared to the POETYK PSO-1 and POETYK PSO-2 trials;
however, deucravacitinib treatment did not increase the risk or
severity of COVID-19 infection. Overall incidence rates of COVID-19
infection and COVID-19-related hospitalization and death in the LTE
trial were consistent with background epidemiologic rates. Through
two years, no new trends or clinically meaningful changes from
baseline in laboratory values, including hematology, chemistry and
lipid parameters, were observed.
“At Bristol Myers Squibb, our pioneering research is leading to
the potential for novel, well-tolerated treatment options for
individuals impacted by serious immune-mediated diseases like
psoriasis. These long-term follow up results add to the growing
body of evidence for deucravacitinib, a first-in-class, oral,
selective allosteric TYK2 inhibitor with a unique mechanism of
action, reinforcing its potential to offer patients with moderate
to severe plaque psoriasis an oral treatment option that addresses
current gaps in care,” said Jonathan Sadeh, MD, MSc, senior vice
president of Immunology and Fibrosis Development, Bristol Myers
Squibb.
Bristol Myers Squibb thanks the patients and investigators
involved in the POETYK PSO clinical trial program.
About Deucravacitinib
Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is an
oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor with
a unique mechanism of action, representing a new class of small
molecules. It is the first and only selective TYK2 inhibitor in
clinical studies across multiple immune-mediated diseases. Bristol
Myers Squibb scientists designed deucravacitinib to selectively
target TYK2, thereby inhibiting signaling of interleukin (IL)-23,
IL-12 and Type 1 interferons (IFN), key cytokines involved in the
pathogenesis of multiple immune-mediated diseases. Deucravacitinib
achieves a high degree of selectivity by binding to the regulatory
domain of TYK2, resulting in allosteric inhibition of TYK2 and its
downstream functions. Deucravacitinib selectively inhibits TYK2 at
physiologically relevant concentrations. At therapeutic doses,
deucravacitinib does not inhibit JAK1, JAK2 or JAK3.
Deucravacitinib is being evaluated in global clinical trials in
multiple immune-mediated diseases, including psoriasis, psoriatic
arthritis, lupus and inflammatory bowel diseases. Deucravacitinib
is under regulatory review with global health authorities,
including the U.S. Food and Drug Administration (FDA) and European
Medical Association (EMA) for the treatment of moderate to severe
plaque psoriasis and by Japan's Ministry of Health, Labour and
Welfare for the treatment of adults with moderate to severe plaque
psoriasis, pustular psoriasis and erythrodermic psoriasis.
About the POETYK PSO Clinical Trial Program
PrOgram to Evaluate the efficacy and safety
of deucravacitinib, a selective TYK2 inhibitor (POETYK)
PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) were global
Phase 3 studies designed to evaluate the safety and efficacy of
deucravacitinib compared to placebo and Otezla® (apremilast) in
patients with moderate to severe plaque psoriasis. Both POETYK
PSO-1, which enrolled 666 patients, and POETYK PSO-2, which
enrolled 1,020 patients, were multi-center, randomized,
double-blind trials that evaluated deucravacitinib (6 mg once
daily) compared with placebo and Otezla (30 mg twice daily). POETYK
PSO-2 included a randomized withdrawal and retreatment period after
Week 24.
The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2
were the percentage of patients who achieved Psoriasis Area and
Severity Index (PASI) 75 response and those who achieved static
Physician's Global Assessment (sPGA) score of 0 or 1 (clear/almost
clear) at Week 16 versus placebo. Key secondary endpoints of the
trials included the percentage of patients who achieved PASI 75 and
sPGA 0/1 compared to Otezla at Week 16 and other measures
evaluating deucravacitinib versus placebo and Otezla.
Following the 52-week POETYK PSO-1 and POETYK PSO-2 trials,
patients could enroll in the ongoing POETYK PSO-LTE trial
(NCT04036435) and receive open-label deucravacitinib 6 mg once
daily. 1,221 patients enrolled in the long-term extension trial and
received at least 1 dose of deucravacitinib. Efficacy was analyzed
utilizing treatment failure rules (TFR) method of imputation, along
with sensitivity analyses using modified non-responder imputation
and as-observed analysis, which have been used in similar analyses
with other agents. In addition to POETYK PSO-1, POETYK PSO-2 and
POETYK PSO-LTE, Bristol Myers Squibb is also evaluating
deucravacitinib in two other Phase 3 studies in psoriasis: POETYK
PSO-3 (NCT04167462) and POETYK PSO-4 (NCT03924427).
About Psoriasis
Psoriasis is a widely prevalent, chronic, systemic
immune-mediated disease that substantially impairs patients’
physical health, quality of life and work productivity. Psoriasis
is a serious global problem, with at least 100 million people
worldwide impacted by some form of the disease, including around 14
million people in Europe and approximately 7.5 million people in
the United States. Nearly one-quarter of people with psoriasis have
cases that are considered moderate to severe. Up to 90 percent of
patients with psoriasis have psoriasis vulgaris, or plaque
psoriasis, which is characterized by distinct round or oval plaques
typically covered by silvery-white scales. Despite the availability
of effective systemic therapy, many patients with moderate to
severe psoriasis remain undertreated or even untreated and are
dissatisfied with current treatments. People with psoriasis report
an impact on their emotional well-being, straining both personal
and professional relationships and causing a reduced quality of
life. Psoriasis is associated with multiple comorbidities that may
impact patients’ well-being, including psoriatic arthritis,
cardiovascular disease, metabolic syndrome, obesity, diabetes,
inflammatory bowel disease and depression.
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.
Otezla® (apremilast) is a registered trademark of Amgen Inc.
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 will be consistent with the results to
date, that deucravacitinib may not receive regulatory approval for
the indication described in this release in the currently
anticipated timeline or at all, any marketing approvals, if
granted, may have significant limitations on their use, and, if
approved, that such product candidate for such 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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