Bristol Myers Squibb Data at ACR Convergence 2020 Underscore Commitment to Advancing Science for Patients with Difficult-to-Treat Immune-Mediated Diseases

Rhea-AI Summary

Bristol Myers Squibb (NYSE:BMY) announced data from 26 studies to be presented at ACR Convergence 2020, showcasing its immunology pipeline. Key highlights include:

• Deucravacitinib: Phase 2 trial results met primary and secondary endpoints for active psoriatic arthritis.
• Orencia: 13 presentations on its effectiveness in rheumatoid arthritis, including a real-world analysis.
• Iberdomide: Phase 2b trial met its primary endpoint in systemic lupus erythematosus patients.

These findings reflect the company's commitment to advancing therapies for immune-mediated diseases.

Positive

• Data from 26 studies showcasing immunology pipeline.
• Deucravacitinib met primary endpoint in Phase 2 trial for psoriatic arthritis.
• Orencia demonstrated comparative effectiveness in rheumatoid arthritis studies.
• Iberdomide met primary endpoint in lupus trial.

Negative

• None.

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE:BMY) today announced that data from 26 company-sponsored and collaborative studies, which demonstrate the depth and breadth of the company’s immunology pipeline and portfolio and commitment to the rheumatology community, will be presented at the American College of Rheumatology (ACR) Convergence 2020, taking place virtually November 5-9, 2020.

Research will be shared on three Bristol Myers Squibb assets spanning four disease areas, including:

• Deucravacitinib (BMS-986165): Late-breaking data from a Phase 2 trial evaluating deucravacitinib in patients with active psoriatic arthritis, which met the primary endpoint and key secondary objectives. In this trial, deucravacitinib was well-tolerated and the safety profile was similar to that observed in the previously reported Phase 2 psoriasis trial. The data will be presented as part of the Late-Breaking Posters Session on November 9 from 9:00 – 11:00 a.m. EST.
• Orencia: A total of 13 company-led presentations demonstrating Bristol Myers Squibb’s leadership in precision medicine in rheumatology with Orencia, including:
  • Data from patients with moderate-to-severe early rheumatoid arthritis (RA) who tested positive (seropositive) for autoantibodies called anti-citrullinated protein antibodies (ACPA) and/or carry the “Shared Epitope” genotype, both of which increase the risk of the development of RA and rapid progression of the disease. This includes a real-world analysis on the comparative effectiveness of Orencia versus TNF-inhibitors in this patient population.
  • New biomarker data showing that higher baseline levels of fine-specificity ACPAs predict greater treatment response in seropositive RA patients receiving Orencia on background methotrexate therapy versus methotrexate alone.
• Iberdomide: Findings from a Phase 2b trial in patients with active systemic lupus erythematosus (SLE) assessing iberdomide, a novel, oral, high-affinity, cereblon ligand that induces degradation of transcription factors Aiolos and Ikaros, which play critical roles in regulating the balance of the immune system. The study met its primary endpoint of SLE Responder Index (SRI-4) response at Week 24, with a greater treatment response in patients with high Type 1 interferon or Aiolos gene expressions. An oral presentation of the efficacy and safety results will take place November 7 at 3:20 p.m. EST. Additionally, a poster detailing the pharmacokinetics, pharmacodynamics and impact on key SLE biomarkers of iberdomide will be shared on November 7 from 9:00 – 11:00 a.m. EST.

“Bristol Myers Squibb’s data at this year’s ACR Convergence embody our science-driven pathway approach and demonstrate our commitment to collaborating with the rheumatology community in pursuit of discoveries that can lead to novel therapies across a number of immune-mediated diseases,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “Emerging biology in key diseases like psoriatic arthritis and lupus, in concert with our continued work in rheumatoid arthritis and juvenile idiopathic arthritis, drives important progress in our mission to deliver transformative therapies for patients living with immune-mediated diseases.”

Bristol Myers Squibb-sponsored abstracts that will be presented at the ACR Convergence 2020 can be found below. Complete abstracts may be accessed online here.

Deucravacitinib Presentation

• Efficacy and Safety of Deucravacitinib (BMS-986165), an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Patients with Active Psoriatic Arthritis: Results From a Phase 2, Double-Blind, Randomized, Placebo-Controlled Trial
  Author: Mease
  Abstract Number: L03
  Session Title: Late-Breaking Posters
  Monday, November 9, 9:00 – 11:00 a.m. EST

Orencia Presentations

• The Comparative Effectiveness of Abatacept Versus TNF Inhibitors in Patients who are ACPA Positive and Have the Shared Epitope: Results from a US National Observational Study
  Author: Harrold
  Abstract Number: 0801
  Session Title: RA – Treatments Poster II: Comparative Effectiveness, Biosimilars, Adherence & the Real World
  Poster Session B
  Saturday, November 7, 9:00 – 11:00 a.m. EST

• Higher Baseline Fine-Specificity ACPAs Predict Greater Treatment Response with Abatacept + MTX Versus MTX Monotherapy in Seropositive RA: A Post Hoc Analysis
  Author: Robinson
  Abstract Number: 0743
  Session Title: RA – Diagnosis, Manifestations, & Outcomes Poster II: Biomarkers
  Poster Session B
  Saturday, November 7, 9:00 – 11:00 a.m. EST

• Clinical Responses and Patient Flow Over 2 Years of Treatment with Abatacept, Including Dose De-Escalation, in Patients with Early, MTX-Naïve, ACPA+ RA: Results From a Phase IIIb Study
  Author: Emery
  Abstract Number: 0826
  Session Title: RA – Treatments Poster II: Comparative Effectiveness, Biosimilars, Adherence & the Real World
  Poster Session B
  Saturday, November 7, 9:00 – 11:00 a.m. EST

• The Comparative Effectiveness of Abatacept Versus Tofacitinib After 6 Months of Treatment in Patients with RA Who Were Anti-citrullinated Protein Antibody Positive at Baseline: Results from a U.S. National Observational Study
  Author: Harrold
  Abstract Number: 0824
  Session Title: RA – Treatments Poster II: Comparative Effectiveness, Biosimilars, Adherence & the Real World
  Poster Session B
  Saturday, November 7, 9:00 – 11:00 a.m. EST

• Infection and Malignancy Outcomes in Patients with RA Treated With Abatacept: Results From a Multinational Surveillance Study
  Author: Hetland
  Abstract Number: 1010
  Session Title: Clinical Practice II (1457–1461)
  Poster Session C
  Sunday, November 8, 9:00 – 11:00 a.m. EST

• A Novel Method for Predicting 1-Year Retention of Abatacept Using Machine Learning Technique
  Author: Alten
  Abstract Number: 1745
  Session Title: RA – Diagnosis, Manifestations, & Outcomes Poster IV: Lifespan of a Disease
  Poster Session D
  Monday, November 9, 9:00 – 11:00 a.m. EST

• Fifty-Two Week Outcomes of Biologic-Naïve RA Patients Treated with Subcutaneous Abatacept in Japanese Multicenter Investigational Study (ORIGAMI Study)
  Author: Tamura
  Abstract Number: 0206
  Session Title: RA – Treatments Poster I: RA Treatments & Their Safety
  Poster Session A
  Friday, November 6, 9:00 – 11:00 a.m. EST

• JIA-ACR50 Response as a Predictor of Minimal Disease Activity in Patients Aged 2–17 Years with Polyarticular-Course JIA Treated With SC Abatacept
  Author: Ruperto
  Abstract Number: 0715
  Session Title: Pediatric Rheumatology – Clinical Poster II: JIA
  Poster Session B
  Saturday, November 7, 9:00 – 11:00 a.m. EST

• Longitudinal Effectiveness of Abatacept in JIA: Results from an Ongoing JIA Registry
  Author: Lovell
  Abstract Number: 0713
  Session Title: Pediatric Rheumatology – Clinical Poster II: JIA
  Poster Session B
  Saturday, November 7, 9:00 – 11:00 a.m. EST

• Response to Abatacept in JIA Categories: Results From the PRCSG/PRINTO JIA Abatacept Phase IV Registry
  Author: Lovell
  Abstract Number: 0714
  Session Title: Pediatric Rheumatology – Clinical Poster II: JIA
  Poster Session B
  Saturday, November 7, 9:00 – 11:00 a.m. EST

• Serum Proteomics from a Phase III, Randomized, Placebo-Controlled Study of Patients with Active Lupus Nephritis: Correlation With Baseline Disease Characteristics and Response to Therapy
  Author: Furie
  Abstract Number: 1822
  Session Title: SLE – Treatment Poster II
  Poster Session D
  Monday, November 9, 9:00 – 11:00 a.m. EST

Iberdomide Presentations

• Efficacy and Safety of Iberdomide in Patients with Active Systemic Lupus Erythematosus: 24-Week Results of a Phase 2, Randomized, Placebo-Controlled Study
  Author: Merrill
  Abstract Number: 0987
  Session Title: SLE – Treatment (0985–0989)
  Saturday, November 7, 3:20 – 3:30 p.m. EST
  Oral presentation

• Iberdomide Decreases B Cells and Plasmacytoid Dendritic Cells, Increases Regulatory T cells and IL-2, and Has Enhanced Clinical Efficacy in Active Systemic Lupus Erythematosus Patients with High Aiolos or the IFN Gene Expression Signature
  Author: Lipsky
  Abstract Number: 0851
  Session Title: SLE – Treatment Poster I
  Poster Session B
  Saturday, November 7, 9:00 – 11:00 a.m. EST

Health Economics and Outcomes Research (HEOR) Presentations

• Prevalence of Morbidity Prior to Diagnosis of Incident Systemic Lupus Erythematosus in the Danish Population
  Author: Hansen
  Abstract Number: 1287
  Session Title: SLE – Diagnosis, Manifestations, & Outcomes Poster II: Comorbidities
  Poster Session C
  Sunday, November 8, 9:00 – 11:00 a.m. EST

• Risk Factors Associated with Interstitial Lung Disease in Patients With RA: Findings From a Retrospective Healthcare Database Analysis
  Author: Craig
  Abstract Number: 1046
  Session Title: Reproductive Issues in Rheumatic Disorders (1497–1501)
  Poster Session C
  Sunday, November 8, 9:00 – 11:00 a.m. EST

• Increased Risk of Hospitalization in Patients with RA who are ACPA+ and Shared Epitope Positive
  Author: Shadick
  Abstract Number: 0756
  Session Title: RA – Diagnosis, Manifestations, & Outcomes Poster II: Biomarkers
  Poster Session B
  Saturday, November 7, 9:00 – 11:00 a.m. EST

About Psoriatic Arthritis

Psoriatic arthritis is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (which occurs when the connective tissue between tendons or ligaments and bone becomes inflamed), dactylitis (inflammation of the fingers and toes), and psoriatic skin and nail lesions. Up to 30 percent of patients with psoriasis will develop psoriatic arthritis. In addition to the loss of physical function, pain and fatigue caused by psoriatic arthritis, the disease can significantly impact the mental and emotional well-being of patients. Patients with psoriatic arthritis are also at increased risk of developing serious comorbidities, including cardiovascular disease, metabolic syndrome and depression, as well as extraarticular manifestations of disease, such as inflammatory bowel disease.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a destructive immune-mediated disease of the joints characterized by inflammation in the joint lining (or synovium), leading to joint damage with chronic pain, stiffness and swelling. RA causes limited range of motion and decreased joint function with long-term disability. The condition is more common in women than in men, who account for 75 percent of patients diagnosed with RA.

About Lupus

Lupus is a chronic, complex immune-mediated disease that results in the immune system attacking multiple organs in the body. Lupus most often affects the joints, skin, brain, lungs, kidneys and blood vessels, causing widespread inflammation and tissue damage in the affected organ(s). There are more than five million people around the world with a form of lupus, and it is most often diagnosed in young women between the ages of 15 and 44. The most common type of lupus is systemic lupus erythematosus (SLE). Up to 60 percent of patients will develop significant kidney disease, lupus nephritis, that can lead to end-stage renal failure and death.

About Deucravacitinib

Deucravacitinib (BMS-986165) is the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases. Deucravacitinib’s selectivity is driven by a unique mechanism of action that is distinct from other kinase inhibitors. TYK2 is an intracellular signaling kinase that mediates signaling of IL-23, IL-12 and Type I IFN, which are naturally occurring cytokines involved in inflammatory and immune responses.

Deucravacitinib is being studied in a wide spectrum of immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. Deucravacitinib is not approved for any use in any country.

About Iberdomide

Iberdomide is a novel, oral, high-affinity, cereblon ligand that induces degradation of transcription factors Aiolos and Ikaros, which play critical roles in regulating the balance of the immune system and are genetically linked to the risk of developing lupus and other diseases. Iberdomide is currently under investigation for the treatment of multiple myeloma, lymphoma and lupus and is not approved for use in any country.

About ORENCIA

ORENCIA^® is an immunomodulator that disrupts the continuous cycle of T-cell activation that characterizes RA, psoriatic arthritis and juvenile idiopathic arthritis (JIA).

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).

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)

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.

Use 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. 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: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

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.

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.

Please click here for Full Prescribing Information.

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 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 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 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, 2019, 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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