Bristol Myers Squibb Announces New Sotyktu™ (deucravacitinib) Long-Term Data Showing Clinical Efficacy Maintained for Up to Two Years with Continuous Treatment in Moderate-to-Severe Plaque Psoriasis

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced new two-year results from the POETYK PSO long-term extension (LTE) trial demonstrating clinical efficacy was maintained with continuous Sotyktu™ (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. This analysis assessed patients from the pivotal POETYK PSO-1 trial who transitioned into the LTE trial. At 112 weeks of Sotyktu treatment, modified non-responder imputation (mNRI) response rates were 82.4% for Psoriasis Area and Severity Index (PASI) 75, 55.2% for PASI 90 and 66.5% for static Physician’s Global Assessment (sPGA) 0/1.

These data (Presentation #D3T01.1F) and 25 additional abstracts demonstrating Bristol Myers Squibb’s robust body of research in dermatology are being presented at the European Academy of Dermatology and Venereology (EADV) Congress, taking place September 7-10, 2022.

“The reality we are facing is that dermatologists and individuals with psoriasis alike have identified the need for more effective and tolerable oral therapies, as psoriasis is a chronic, systemic, immune-mediated disease that is associated with serious comorbidities,” said Dr. Mark Lebwohl, MD, Dean of Clinical Therapeutics at the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine, Mount Sinai (New York); Dr. Lebwohl was also a participant in the Publication Steering Committee for this study. “These new long-term results showing durable efficacy through up to two years of continuous treatment further support the use of once-daily Sotyktu for people with moderate-to-severe plaque psoriasis and address the need for more effective oral treatment options.”

Of the 262 Sotyktu patients in the analysis, 171 had achieved PASI 75 at Week 16 of the POETYK PSO-1 trial, and among these patients, efficacy was maintained for up to 112 weeks, including response rates for PASI 75 (Week 16, 100%; Week 52, 90.1%; Week 112, 91.0%), PASI 90 (Week 16, 62.6%; Week 52, 64.9%; Week 112, 63.0%) and sPGA 0/1 (Week 16, 84.2%; Week 52, 73.7%; Week 112, 73.5%).

“These two-year follow-up data demonstrate the durable efficacy offered by Sotyktu and its potential to provide long-term, clinically relevant improvement for individuals with moderate-to-severe plaque psoriasis,” said Jonathan Sadeh, MD, MSc, senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb. “At Bristol Myers Squibb, we are committed to exploring pathbreaking science to elevate care for people burdened by serious immune-mediated diseases and are focused on continuing our research with Sotyktu and other novel molecules in our deep and differentiated portfolio.”

Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PSO clinical trial program.

Bristol Myers Squibb Data Presentations at EADV 2022
Late-Breaking Presentations

• Deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, in Asian patients with moderate-to-severe plaque psoriasis: findings from the phase 3 POETYK PSO-3 trial
  Author: Zhang Jianzhong
  Abstract Number: D3T01.1B
  Session: Saturday, September 10, 2:45-3:00 a.m. EDT

• Deucravacitinib long-term efficacy with continuous treatment in plaque psoriasis: 2-year results from the phase 3 POETYK PSO study program
  Author: Mark Lebwohl
  Abstract Number: D3T01.1F
  Session: Saturday, September 10, 3:45-4:00 a.m. EDT

Clinical Presentations

• COVID-19-related adverse events in the phase 3 POETYK trials of the allosteric TYK2 inhibitor, deucravacitinib, in patients with moderate-to-severe plaque psoriasis
  Author: Diamant Thaci
  Oral presentation FC06: Free communications in psoriasis
  Abstract Number: FC06.03
  Session: Saturday, September 10, 8:35-9:45 a.m. EDT

• Efficacy and safety of deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, in patients with active systemic lupus erythematosus: results from a phase 2, randomized, double-blind, placebo-controlled study
  Author: Marilyn Pike
  Abstract Number: P0377
  E-poster

• Efficacy of deucravacitinib treatment in patients with moderate-to-severe plaque psoriasis who relapsed during the randomized withdrawal and maintenance period in POETYK PSO-2: 48-week findings from the POETYK long-term extension trial
  Author: Richard B. Warren
  Abstract Number: P1456
  E-poster

• Deucravacitinib, an oral, selective, tyrosine kinase 2 inhibitor in patients with moderate-to-severe plaque psoriasis: 52-week efficacy by prior treatment in the phase 3 POETYK PSO-1 trial
  Author: Jerry Bagel
  Abstract Number: P1476
  E-poster

• Deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, in Japanese patients with moderate-to-severe plaque, erythrodermic, or generalized pustular psoriasis: efficacy and safety results from the open-label, phase 3 POETYK PSO-4 trial
  Author: Shinichi Imafuku
  Abstract Number: P1477
  E-poster

• Deucravacitinib in plaque psoriasis: 2-year laboratory results from the phase 3 POETYK PSO program
  Author: Neil Korman
  Abstract Number: P1481
  E-poster

Clinical Encore Presentations

• Safety and efficacy of deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, in patients with psoriatic arthritis: 52-week results from a randomised phase 2 trial
  Author: Philip J. Mease
  Abstract Number: P1447
  E-poster

• Deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, versus placebo and apremilast in moderate-to-severe plaque psoriasis: safety analysis by prior therapy subgroups in the phase 3 POETYK PSO-1 and PSO-2 trials
  Author: Richard B. Warren
  Abstract Number: P1455
  E-poster

• Deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, in a phase 2 trial in psoriatic arthritis: achievement of minimal disease activity and its components
  Author: Arthur Kavanaugh
  Abstract Number: P1457
  E-poster

• Deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, versus placebo and apremilast in moderate-to-severe plaque psoriasis: achievement of absolute PASI thresholds in the phase 3 POETYK PSO-1 and PSO-2 trials
  Author: Mark Lebwohl
  Abstract Number: P1458
  E-poster

• Deucravacitinib, a selective tyrosine kinase 2 inhibitor, versus placebo and apremilast in psoriasis: reductions in individual component scores and body regions of the psoriasis area and severity index in the phase 3 POETYK PSO-1 and PSO-2 trials
  Author: Jeffrey M. Sobell
  Abstract Number: P1459
  E-poster

Clinical Pharmacology and Translational Encore Presentations

• Tyrosine kinase 2 inhibition promotes hair growth, restores hair follicle immune privilege, and reduces perifollicular inflammation in lesional alopecia areata skin ex vivo and reverses the induction of human alopecia areata in a humanized mouse model
  Author: Janin Edelkamp
  Oral presentation FC04: Free communications in hair and nail disorders
  Abstract Number: FC04.02
  Session: Saturday, September 10, 2:40-2:50 a.m. EDT

• Deucravacitinib exposure-response analyses in patients with moderate-to-severe psoriasis
  Author: Jun Shen
  Abstract Number: P1480
  E-poster

Health Economics and Outcomes Research (HEOR) Presentations

• Real-world treatment patterns in patients with psoriatic arthritis
  Author: Jiyoon Choi
  Abstract Number: P0393
  E-poster

• Treatment patterns and patient characteristics of patients with psoriasis treated with systemic therapy in Japan: a retrospective claims database study
  Author: Yayoi Tada
  Abstract Number: P0471
  E-poster

• Improvement in patient-reported outcomes with deucravacitinib in moderate-to-severe psoriasis: results from the POETYK PSO-1 and POETYK PSO-2 randomized phase 3 clinical trials
  Author: Bruce Strober
  Abstract Number: P0472
  E-poster

• Prediction of psoriasis progression to psoriatic arthritis: development of a model based on the Italian PsoReal registry data
  Author: Simone Cazzaniga
  Abstract Number: P0972
  E-poster
• Real-world treatment patterns of adults with psoriasis initiated on apremilast or biologics
  Author: Jashin J. Wu
  Abstract Number: P1432
  E-poster

• Real-world data study in healthcare costs from adults with psoriasis who initiated treatment with apremilast or biologics
  Author: Jashin J. Wu
  Abstract Number: P1433
  E-poster

• Early discontinuation of apremilast in patients with psoriasis
  Author: Lana Schmidt
  Abstract Number: P1434
  E-poster

• Unmet needs in skin and joint symptoms: control and impact on quality of life in actively treated patients with psoriasis
  Author: Bruce Strober
  Abstract Number: P1435
  E-poster

• Patient preferences for treatment of moderate-to-severe psoriasis in Japan
  Author: Mayumi Komine
  Abstract Number: P1552
  E-poster

• Epidemiology of psoriasis in Italy with a focus on treatment patterns and cost of laboratory monitoring by using administrative claim data
  Author: Simone Cazzaniga
  Abstract Number: P1594
  E-poster

• Patients’ characteristics and healthcare resource use in patients with psoriasis who discontinued biologic therapy: a retrospective cohort study using the North-West London Discover database
  Author: Sue Beecroft
  Abstract Number: P1600
  E-poster

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 one 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 has evaluated deucravacitinib in two other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462) and POETYK PSO-4 (NCT03924427).

The Journal of the American Academy of Dermatology recently published primary analysis results from the POETYK PSO-1 study.

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.

About Sotyktu™

Sotyktu™ (deucravacitinib) is a selective, allosteric inhibitor of tyrosine kinase 2 (TYK2). TYK2 is a member of the Janus kinase (JAK) family. Sotyktu binds to the regulatory domain of TYK2, stabilizing an inhibitory interaction between the regulatory and the catalytic domains of the enzyme. This results in allosteric inhibition of receptor-mediated activation of TYK2 and its downstream activation of Signal Transducers and Activators of Transcription (STATs) as shown in cell-based assays. Janus kinases function as pairs of homo- or heterodimers in the JAK-STAT pathways. TYK2 pairs with JAK1 to mediate multiple cytokine pathways and also pairs with JAK2 to transmit signals as shown in cell-based assays. The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness in the treatment of adults with moderate-to-severe plaque psoriasis is not currently known.

The U.S. Food and Drug Administration approved Sotyktu for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy on September 9, 2022. Sotyktu is also under regulatory review by the European Medicines Agency and other health authorities around the world 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.

INDICATION

SOTYKTU™ (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Limitations of Use:

SOTYKTU is not recommended for use in combination with other potent immunosuppressants.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.

Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:

• with chronic or recurrent infection
• who have been exposed to tuberculosis
• with a history of a serious or an opportunistic infection
• with underlying conditions that may predispose them to infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.

Viral Reactivation

Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.

Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.

Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.

Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo.

Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.

Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.

Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.

Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.

ADVERSE REACTIONS

Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.

SPECIFIC POPULATIONS

Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.

Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.

Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.

SOTYKTU is available in 6 mg tablets.

Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.

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.

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 results of future post-marketing studies may not be consistent with the results of this study, that Sotyktu (deucravacitinib) for the indication described in this release will be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of such product candidate for the indication described in this release may be contingent upon verification and description of clinical benefit in additional confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that 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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