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Bristol Myers Squibb showcases research advancing outcomes addressing hard-to-treat blood cancers and diseases across small molecule, biologic and cell therapies at ASH 2020

Results for our CD19-targeted CAR T cell therapy lisocabtagene maraleucel (liso-cel) in patients with heavily pretreated mantle cell lymphoma and relapsed/refractory chronic lymphocytic leukemia

Data showcasing BCMA-targeted CAR T cell therapy idecabtagene vicleucel (ide-cel), including updated results from the Phase 1 CRB-401 study and analyses of health-related quality of life, safety and correlative endpoints from the pivotal KarMMa study in heavily pretreated patients with relapsed/refractory multiple myeloma

Four oral presentations featuring data from the Phase 3 QUAZAR® AML-001 study of Onureg® (azacitidine tablets) in patients with acute myeloid leukemia in first remission, including longitudinal assessment of measurable residual disease

First clinical data for triplet combination of iberdomide, a novel CELMoD® agent, with daratumumab or bortezomib and dexamethasone in patients with heavily pretreated relapsed/refractory multiple myeloma

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #AML—Bristol Myers Squibb (NYSE: BMY) today announced the presentation of research across its hematology portfolio at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, which will take place virtually from December 5 to 8, 2020. Data from nearly 100 company-sponsored studies will be featured, reinforcing the depth and diversity of the company’s development program and commitment to discovering potential new options to treat patients with blood cancers and other serious hematologic diseases.

Key data being presented by Bristol Myers Squibb and its partners at the 62nd ASH Annual Meeting and Exposition include:

  • Multiple analyses of CD19-targeted CAR T cell therapy liso-cel, highlighting studies of the treatment in additional hematologic malignancies, including results from the Phase 1 TRANSCEND NHL 001 study in patients with heavily pretreated, relapsed or refractory (R/R) mantle cell lymphoma and results from the Phase 1 TRANSCEND CLL 004 study in patients with R/R chronic lymphocytic leukemia. Moreover, a matching-adjusted indirect comparison of liso-cel vs. axicabtagene ciloleucel and tisagenlecleucel, and an analysis of outcomes in the outpatient setting will highlight new insights in treating R/R large B-cell lymphoma.
  • Reinforcing the company’s commitment to patients with multiple myeloma, presentations evaluating BCMA-targeted CAR T cell therapies in collaboration with bluebird bio, including: an analysis for ide-cel from the pivotal KarMMA study evaluating quality of life outcomes in R/R multiple myeloma. Additional safety, patient subgroup and correlative analyses from the KarMMa study highlighting the impact of prior therapies and features associated with CAR T expansion. In addition, updated results from the Phase 1 CRB-401 trial evaluating safety and responses in heavily pretreated patients with longer follow-up will be reported. Finally, updated results from the Phase 1 CRB-402 study of early-stage CAR T cell therapy bb21217 will also be presented.
  • The first efficacy and safety results from a triplet combination study including iberdomide, a cereblon E3 ligase modulator (CELMoD)® agent, with daratumumab or bortezomib and dexamethasone in patients with heavily pretreated R/R multiple myeloma.
  • More than 40 abstracts highlighting Bristol Myers Squibb’s recent treatment advances for hard-to-treat myeloid diseases, with multiple quality of life analyses including data on reduced hospitalizations and associated estimated costs with Onureg® (azacitidine tablets) in patients with acute myeloid leukemia in first remission from the Phase 3 QUAZAR® AML-001 study. New health-related quality of life outcomes from the Phase 3 BELIEVE and MEDALIST studies of Reblozyl® (luspatercept-aamt), in beta thalassemia and lower-risk myelodysplastic syndromes, will also be presented.

“Our purpose continues to be translating groundbreaking research across many hard-to-treat diseases and the nearly 100 studies being presented at this meeting illustrate our continued focus, with new modalities and different targets in our pipeline supporting the next waves of innovation in hematology,” said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. “This year’s ASH represents an opportunity to highlight new data supporting our recently approved therapies, as well as other important advances across our pipeline. As we mark one year in growing a combined organization, we look forward to ASH as an exchange that underscores our commitment to delivering potentially beneficial survival outcomes and quality of life improvements for patients.”

Summary of Presentations:
Selected Bristol Myers Squibb studies at the 62nd ASH Annual Meeting and Exposition include:

Acute Myeloid Leukemia

  • Escalated Dosing Schedules of CC-486 are Effective and Well Tolerated for Patients Experiencing First Acute Myeloid Leukemia (AML) Relapse: Results from the Phase III QUAZAR AML-001 Maintenance TrialPresenter: H. DoehnerPresentation: #111Date/Time: Saturday, December 5, 9:30 am EST
  • Health-related Quality of Life with CC-486 in Patients with Acute Myeloid Leukemia in First Remission Following Induction Chemotherapy: Results from the Phase III QUAZAR AML-001 Maintenance TrialPresenter: G. RobozPresentation: #214Date/Time: Saturday, December 5, 12:15 pm EST
  • CC-486 Reduces Hospitalization and Associated Estimated Costs in Patients with Acute Myeloid Leukemia in First Remission After Intensive Chemotherapy: Results of the QUAZAR AML-001 Maintenance TrialPresenter: E. OliviaPresentation: #621Date/Time: Monday, December 7, 9:15 am EST
  • CC-486 Prolongs Survival for Patients with Acute Myeloid Leukemia in Remission after Intensive Chemotherapy Independent of Presence of Measurable Residual Disease at Study Entry: Results from the QUAZAR-AML-001 Maintenance TrialPresenter: G. RobozPresentation: #692Date/Time: Monday, December 7, 2:30 pm EST
  • CC-486 Improves Overall Survival and Relapse-free Survival for Patients with Acute Myeloid Leukemia in First Remission after Intensive Chemotherapy, Regardless of Amount of Consolidation Received: Results from the Phase III QUAZAR AML-001 Maintenance TrialPresenter: A. WeiPoster: #1036Date: Saturday, December 5
  • Gastrointestinal Events and Management Strategies for Patients with Acute Myeloid Leukemia (AML) in First Remission Receiving CC-486 in the Randomized, Placebo-controlled, Phase III QUAZAR AML-001 Maintenance Trial ​Presenter: F. RavandiPoster: #1917Date: Sunday, December 6
  • Real-World Use of Enasidenib in Relapsed or Refractory (RR) Acute Myeloid Leukemia (AML) Is Associated with Reduced Risk of Disease Progression and DeathPresenter: A. KlinkPoster: #1912Date: Sunday, December 6

Beta Thalassemia

  • Health-Related Quality of Life Outcomes for Patients with Transfusion-Dependent Beta-Thalassemia Treated With Luspatercept in the BELIEVE TrialPresenter: M. CappelliniPresentation: #364Date/Time: Sunday, December 6, 9:30 am EST
  • Longitudinal Effect of Luspatercept Treatment on Iron Overload and Iron Chelation Therapy in Adult Patients with β-Thalassemia in the BELIEVE TrialPresenter: O. HerminePoster: #1697Date: Sunday, December 6
  • Sustained Reductions in Red Blood Cell (RBC) Transfusion Burden and Events in β-Thalassemia With Luspatercept: Longitudinal Results of the BELIEVE TrialPresenter: A. TaherPoster: #1695Date: Sunday, December 6

Lymphoma and Chronic Lymphocytic Leukemia

  • Safety and Preliminary Efficacy in Patients with Relapsed/Refractory Mantle Cell Lymphoma Receiving Lisocabtagene Maraleucel in TRANSCEND NHL 001Presenter: M. PalombaPresentation: #118Date/Time: Saturday, December 5, 9:45 am EST
  • Subgroup Analyses of Elderly Patients Aged ≥ 70 years in MAGNIFY: A Phase IIIb Interim Analysis of Induction R2 Followed by Maintenance in Relapsed/Refractory Indolent Non-Hodgkin LymphomaPresenter: F. LansiganPresentation: #340Date/Time: Sunday, December 6, 10:30 am EST
  • Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients ​Presenter: C. YasenchakPresentation: #471​Date/Time: Sunday, December 6​, 2:15 pm​ EST
  • TRANSCEND CLL 004: Phase 1 Cohort of Lisocabtagene Maraleucel (liso-cel) in Combination With Ibrutinib for Patients with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)Presenter: W. WierdaPresentation: #544Date/Time: Monday, December 7, 7:30 am EST
  • Updated Follow-up of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated with Lisocabtagene Maraleucel in the Phase 1 Monotherapy Cohort of TRANSCEND CLL 004, Including High-Risk and Ibrutinib-Treated PatientsPresenter: T. SiddiqiPresentation: #546Date/Time: Monday, December 7, 8:00 am EST
  • Outcomes of Treatment With the Chimeric Antigen Receptor (CAR) T Cell Therapy Lisocabtagene Maraleucel (liso-cel) in the Nonuniversity Setting: Initial Results from the OUTREACH StudyPresenter: J. GodwinPoster: #1196Date: Saturday, December 5
  • Patients With Relapsed/Refractory Marginal Zone Lymphoma in the MAGNIFY Phase IIIb Interim Analysis of Induction R2 Followed by MaintenancePresenter: M. ColemanPoster: #1123Date: Saturday, December 5
  • Costs of Postinfusion Monitoring by Site of Care for Patients with Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Who Received Third-Line or Later Treatment with Lisocabtagene Maraleucel (liso-cel) in the TRANSCEND NHL 001 and OUTREACH TrialsPresenter: M. PalombaPoster: #2514Date: Sunday, December 6
  • Matching-Adjusted Indirect Comparison (MAIC) of Lisocabtagene Maraleucel (Liso-cel) vs Axicabtagene Ciloleucel (Axi-cel) and Tisagenlecleucel in Relapsed/Refractory (R/R) Large B‐Cell Lymphoma (LBCL)Presenter: D. MaloneyPoster: #2116Date: Sunday, December 6
  • Nivolumab Combined with Brentuximab Vedotin (BV) for Relapsed/Refractory Mediastinal Gray Zone Lymphoma (R/R MGZL): Primary Efficacy and Safety Analysis of Phase 2 CheckMate 436 StudyPresenter: A. SantoroPoster: #2045Date: Sunday, December 6
  • Qualitative Analysis of the Treatment Experience and Well-Being of Patients with Relapsed/Refractory Large B-Cell Lymphoma Enrolled in 2 Trials of Lisocabtagene Maraleucel (liso-cel) during the Initial Stages of TherapyPresenter: T. SiddiqiPoster: #2565Date: Sunday, December 6
  • Long-Term Results from a Phase 1b Study of Avadomide in Combination with Obinutuzumab in Patients with Relapsed and/or Refractory B-Cell Non-Hodgkin LymphomaPresenter: J. MichotPoster: #2939Date: Monday, December 7

Multiple Myeloma

  • Updated results from the Phase I CRB-402 study of anti-BCMA CAR-T cell therapy bb21217 in patients with relapsed and refractory multiple myeloma: correlation of expansion and duration of response with T cell phenotypePresenter: M. AlsinaPresentation: #130Date/Time: Saturday, December 5, 9:45 am EST
  • Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-Directed CAR T Cell Therapy, in Patients with Relapsed and Refractory Multiple Myeloma: Updated Results from Phase 1 CRB-401 StudyPresenter: Y. LinPresentation: #131Date/Time: Saturday, December 5, 10:00 am EST
  • Secondary Quality of Life Domains in Patients with Relapsed and Refractory Multiple Myeloma treated with the BCMA Directed CAR T cell therapy Idecabtagene Vicleucel (ide-cel, bb2121): results from the KarMMa Clinical TrialPresenter: N. ShahPresentation: #437Date/Time: Sunday, December 6, 12:15 pm EST
  • First results of Iberdomide (IBER; CC-220) in Combination With Dexamethasone (DEX) and Daratumumab (DARA) or Bortezomib (BORT) in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM)Presenter: N. Van de DonkPresentation: #724Date/Time: Monday, December 7, 1:30 pm EST
  • Characterization of Cytokine Release Syndrome in the KarMMa Study of Idecabtagene Vicleucel (ide-cel, bb2121) for Relapsed and Refractory Multiple MyelomaPresenter: A. KansagraPoster: #1378Date: Saturday, December 5
  • Efficacy and Safety of Idecabtagene Vicleucel (ide-cel, bb2121) in Elderly Patients With Relapsed and Refractory Multiple Myeloma: KarMMa Subgroup AnalysisPresenter: J. BerdejaPoster: #1367Date: Saturday, December 5
  • Molecular and Phenotypic Profiling of Drug Product and Post-Infusion Samples from CRB-402, an Ongoing: Phase I Clinical Study of bb21217 a BCMA Directed CAR T Cell TherapyPresenter: O. FinneryPoster: #1401Date: Saturday, December 5
  • Association of Baseline and Postinfusion Biomarkers with Safety and Efficacy Endpoints in Patients Treated with Orvacabtagene Autoleucel (orva-cel; JCARH125) in the Phase 1/2 EVOLVE StudyPresenter: P. McCarthyPoster #2350Date: Sunday, December 6
  • Dose- and Schedule-Dependent Immunomodulatory Effects of the Novel CELMoD Agent CC-92480 in Patients with Relapsed/Refractory Multiple MyelomaPresenter: L. WongPoster: #2295Date: Sunday, December 6
  • Orvacabtagene Autoleucel (orva-cel; JCARH125): A Fully Human BCMA-Targeted Second-Generation CAR T Cell Product Characterized by a Predominant Central Memory Phenotype with High In Vitro and In Vivo Proliferative Potential and Sustained In Vivo PersistencePresenter: L. ColonnaPoster: #2350Date: Sunday, December 6
  • Pomalidomide, Dexamethasone, and Daratumumab after Lenalidomide Treatment in Relapsed Refractory Multiple Myeloma: Updated Results from an Open-Label, Multicenter, Phase 2 TrialPresenter: N. BahlisPoster: #2314Date: Sunday, December 6
  • Idecabtagene Vicleucel (ide-cel, bb2121) in Relapsed and Refractory Multiple Myeloma: Analyses of High-Risk Subgroups in the KarMMa StudyPresenter: N. RajePoster: #3234Date: Monday, December 7

Myelodysplastic Syndromes

  • Health-Related Quality of Life Outcomes in Patients with Myelodysplastic Syndromes with Ring Sideroblasts Treated with Luspatercept in the MEDALIST StudyPresenter: E. OliviaPoster: #1611Date: Saturday, December 5
  • Efficacy and Safety of Luspatercept Treatment in Patients with Myelodysplastic Syndrome/ Myeloproliferative Neoplasm with Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T): A Retrospective Analysis from the MEDALIST StudyPresenter: R. KomrokjiPoster: #3111Date: Monday, December 7
  • Physicians’ Experience in Blood Supply Shortages and the Top Factors That Impact the Clinical, Economic, and Humanistic Outcomes of Myelodysplastic Syndrome (MDS) Patients in Five European CountriesPresenter: J.TangPoster: #3492Date: Monday, December 7

Myelofibrosis

  • Long-Term Safety of Fedratinib in Patients with Intermediate- or High-Risk MyelofibrosisPresenter: A. PardananiPoster: #3006Date: Monday, December 7

Preclinical Presentations

  • FEIBA® and NovoSeven® Neutralize the Anticoagulant Effects of a Novel Small Molecule FXIa Inhibitor BMS-986177/JNJ-70033093 in Human Plasma and Whole Blood In VitroPresenter: M. BuncePoster: #1809Date: Sunday, December 6

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision—transforming people’s 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 scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at 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. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

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 the 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 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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Bristol Myers Squibb

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609-252-7509

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908-673-9711

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Bristol Myers Squibb provides update on Phase 3 IDHENTIFY trial in patients with relapsed or refractory acute myeloid leukemia

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #AML—Bristol Myers Squibb (NYSE:BMY) today announced that the Phase 3 IDHENTIFY study evaluating IDHIFA® (enasidenib) plus best supportive care (BSC) versus conventional care regimens, which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not meet the primary endpoint of overall survival (OS) in patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. The safety profile of IDHIFA was consistent with previously reported findings. The company will complete a full evaluation of the IDHENTIFY data and work with investigators to present detailed results at a future medical meeting.

“While we are disappointed by the outcome of the IDHENTIFY study, we remain confident in IDHIFA’s established role as a treatment option for patients with relapsed or refractory AML with an IDH2 mutation and are grateful to all those who participated in the study,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. “AML is one of the most difficult-to-treat blood cancers, and we’re committed to furthering our research and improving on the standards of care for patients living with this aggressive disease.”

In August 2017, Bristol Myers Squibb received full approval in the U.S. for IDHIFA for the treatment of adult patients with R/R AML with an IDH2 mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and positive for an IDH2 mutation, which represents up to 19 percent of AML patients. IDHIFA is also approved in Australia and Canada.

About IDHENTIFY

IDHENTIFY (NCT02577406) is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs), which include continuous 28-day cycles of best supportive care (BSC) only, azacitidine subcutaneously (SC) plus BSC, low-dose cytarabine SC plus BSC, or intermediate-dose cytarabine intravenously plus BSC, in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation. The primary endpoint of the study was overall survival. Key secondary endpoints included overall response rate, event-free survival, duration of response and time to response.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is the most common type of acute leukemia. AML starts in the bone marrow but moves quickly into the blood. Unlike in normal blood cell development, in AML, the rapid buildup of abnormal white blood cells in the bone marrow may interfere with the production of normal blood cells, resulting in decreased healthy white blood cells, red blood cells and platelets. AML is a complex, diverse disease associated with multiple genetic mutations, such as the isocitrate dehydrogenase-2 (IDH2) mutation, and usually worsens quickly and can lead to death if not treated. IDH2 mutations are present in up to 19 percent of AML cases. AML has a high relapse rate, meaning following patients’ initial response to treatment, their disease is likely to return, signifying an unmet need for targeted therapy options. The worldwide incidence of AML is estimated to be over 350,000 cases. In the United States, there will be an estimated 21,450 new cases of AML this year, with an estimated 10,920 deaths resulting from the disease.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About IDHIFA

IDHIFA (enasidenib) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation as detected by an FDA-approved test. IDHIFA is also approved in Australia and Canada.

Important Safety Information

BOXED WARNING: DIFFERENTIATION SYNDROME

Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: See Boxed WARNING. In the AG221-C-001 Phase 2 clinical trial, 14% of patients treated with IDHIFA experienced differentiation syndrome, which may be life-threatening or fatal if not treated. Differentiation syndrome has been observed with and without concomitant hyperleukocytosis, as early as 1 day and at up to 5 months after IDHIFA initiation. Symptoms in patients treated with IDHIFA included acute respiratory distress represented by dyspnea and/or hypoxia and need for supplemental oxygen; pulmonary infiltrates and pleural effusion; renal impairment; fever; lymphadenopathy; bone pain; peripheral edema with rapid weight gain; and pericardial effusion. Hepatic, renal, and multi-organ dysfunction have also been observed. If differentiation syndrome is suspected, initiate systemic corticosteroids and hemodynamic monitoring until improvement. Taper corticosteroids only after resolution of symptoms. Differentiation syndrome symptoms may recur with premature discontinuation of corticosteroids. If severe pulmonary symptoms requiring intubation or ventilator support and/or renal dysfunction persist for more than 48 hours after initiation of corticosteroids, interrupt IDHIFA until signs and symptoms are no longer severe. Hospitalization for close observation and monitoring of patients with pulmonary and/or renal manifestation is recommended.

Embryo-Fetal Toxicity: Based on animal embryo-fetal toxicity studies, IDHIFA can cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with IDHIFA and for at least 2 months after the last dose. Pregnant women, patients becoming pregnant while receiving IDHIFA, or male patients with pregnant female partners should be apprised of the potential risk to the fetus.

ADVERSE REACTIONS

  • The most common adverse reactions (≥20%) included total bilirubin increased (81%), calcium decreased (74%), nausea (50%), diarrhea (43%), potassium decreased (41%), vomiting (34%), decreased appetite (34%), and phosphorus decreased (27%)
  • The most frequently reported ≥Grade 3 adverse reactions (≥5%) included total bilirubin increased (15%), potassium decreased (15%), phosphorus decreased (8%), calcium decreased (8%), diarrhea (8%), differentiation syndrome (7%), non-infectious leukocytosis (6%), tumor lysis syndrome (6%), and nausea (5%)
  • Serious adverse reactions were reported in 77.1% of patients. The most frequent serious adverse reactions (≥2%) were leukocytosis (10%), diarrhea (6%), nausea (5%), vomiting (3%), decreased appetite (3%), tumor lysis syndrome (5%), and differentiation syndrome (8%). Differentiation syndrome events characterized as serious included pyrexia, renal failure acute, hypoxia, respiratory failure, and multi-organ failure

LACTATION

Many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants, advise women not to breastfeed during treatment with IDHIFA and for at least 2 months after the last dose.

Please see full Prescribing Information, including Boxed WARNING

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, the possibility of unfavorable results from further clinical trials involving IDHIFA (enasidenib). 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.

Contacts

Media Inquiries:
media@bms.com
609-252-3345

Rose Weldon

rose.weldon@bms.com

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Nina Goworek

908-673-9711

nina.goworek@bms.com

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Bayer names Lori Moore as vice president, head of U.S. Pharmaceutical Communications

WHIPPANY, N.J.–(BUSINESS WIRE)–Lori Moore, former Managing Director at Deloitte, will be joining Bayer as Vice President, Head of Pharmaceutical Communications in the United States, the company announced today.


Moore spent the last six years in senior communications roles at Deloitte, most recently as the Managing Director leading efforts to transform internal communications. Prior to joining Deloitte, Moore served in communications leadership positions at Novo Nordisk and Sanofi. In her new role at Bayer, Moore will be responsible for developing and executing external and internal communication strategies for the company’s pharmaceutical portfolio in the United States, with a specific emphasis on cardiology, oncology, women’s health, hematology and radiology.

Moore officially starts today and will be based in Whippany, N.J. She will report directly to Raymond F. Kerins, Jr., Senior Vice President of Corporate Affairs, and serve on the U.S. Corporate Affairs and Pharmaceutical Leadership Teams.

“I’m delighted to have Lori join the Bayer team as she brings more than 20 years of experience in the pharmaceutical industry,” Kerins said. “Her impressive knowledge and expertise will help us advance our communications about the company’s pharmaceutical business here in this country.”

Throughout her career, Moore has served in various positions leading marketing communications, corporate branding, internal communications and public relations. In her most recent role, she was responsible for transforming and implementing a new internal communications strategy to support the business needs at Deloitte. Earlier, she served as the head of communications for Deloitte’s audit and risk advisory business.

Prior to her time at Deloitte, Moore spent nine years at Novo Nordisk as the Executive Director for Communications and Public Affairs, where she oversaw all strategic communications, including brand and reputation management, crisis management and employee engagement in the United States. Earlier in her career, Moore managed the Global Product communications for Sanofi where she was responsible for the communications around product launches, programs and issues management.

“I’m honored to join the Bayer team at such a critical time of growth for the division,” Moore said. “Bringing innovative medicines to market is at the heart of what we do, and I look forward to communicating this important story with patients, physicians and providers throughout the United States.”

Moore holds a Master of Science degree in Communications from Northwestern University and a Bachelor of Arts in Journalism from Northern Illinois University.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.

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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Carolyn Nagle

Bayer U.S.

Email: carolyn.nagle@bayer.com
Mobile: 201-419-0337