Tag: Bristol Myers Squibb

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

Post author By Michelle Dryden
Post date November 11, 2020
No Comments on 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 62^nd 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 62^nd 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 62^nd 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: #471Date/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 R²Followed 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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Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Nina Goworek

908-673-9711

nina.goworek@bms.com

Tags #Diseases, Bristol Myers Squibb, Hematology, patients, patients#Diseases

Education

UNCF, Bristol Myers Squibb announce second cohort of the Ernest E. Just Postgraduate Fellowship and extension of partnership through 2026

Fellowship program honors Dr. Just, a pioneering biologist and one of the most prominent African American scientists of the twentieth century

WASHINGTON & PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #UNCF–The UNCF and Bristol Myers Squibb (NYSE: BMY) today announced the second cohort of the Ernest E. Just Postgraduate Fellowship in the Life Sciences, as well as an extension of the organizations’ innovative partnership that was initially established in 2017.

Antentor Hinton Jr., Ph.D. and Cornelius Taabazuing, Ph.D. are the latest outstanding recipients of this highly competitive fellowship. Dr. Hinton is a Senior Research Fellow at the University of Iowa conducting research at the Francois M. Abboud Cardiovascular Research Center, and Dr. Taabazuing is an American Cancer Society Research Fellow working in the Chemical Biology Program at the Memorial Sloan-Kettering Cancer Center in New York City. UNCF and Bristol Myers Squibb have also agreed to extend this partnership through 2026. Over that time, eight cohorts of African American scientists will be selected to participate in this fellowship program and engage with Bristol Myers Squibb scientific leaders to learn about biopharmaceutical drug research and development.

“We are very excited about the opportunity to extend our partnership with Bristol Myers Squibb and expand the number of E. E. Just fellows in the program with the second cohort of African American scientists,” said Chad Womack, Ph.D., founder of the Ernest E. Just Life Science initiative and the Senior Director for STEM Programs and Initiatives at the UNCF. “Drs. Hinton and Taabazuing are outstanding scientists who have clearly demonstrated a very high level of scientific accomplishment and leadership with their cutting-edge research in their respective fields.”

Womack continued, “We are greatly appreciative of the tremendous support that Bristol Myers Squibb has and continues to provide for this program. It gives us a unique opportunity to assist our fellows in their transition into independent careers as academic scientists or R&D professionals in the biopharma industry. Through this initiative and additional commitment, we will continue to build a community of outstanding African American biomedical scientists.”

Dr. Hinton earned his bachelor’s degree at Winston Salem State University and Ph.D. from the Integrative Molecular Biomedical Sciences program at Baylor College of Medicine. Dr. Hinton’s work is focused on elucidating interactions between mitochondrial lipids and OPA-1 in skeletal muscle. The award will help move his research towards a human model with primary skeletal muscle cell lines and will assist his investigations into how the mitochondrial contact site and cristae organizational system proteins interact with OPA-1 and participate in regulating lipid-mitochondrial dynamics. Dr. Hinton’s research has direct implications for understanding the underlying pathophysiology of Type II Diabetes – a disease that disproportionately affects African Americans.

Dr. Taabazuing earned his bachelor’s and Ph.D. degrees at the University of Massachusetts at Amherst. His postdoctoral research at the Memorial Sloan-Kettering Cancer Center is focused on the role caspase-1 plays in the immunoregulation and pathogenesis of cancer, autoimmune disorders and inflammation. The award will help Dr. Taabazuing further his cutting-edge translational research to identify and characterize novel caspase-1 substrates with the goal of providing novel insights into pathogenic mechanisms that will potentially serve as a platform for drug design and pharmacotherapeutic intervention.

“Bristol Myers Squibb is proud to continue our support of the E. E. Just Postgraduate Fellowship program and we congratulate Drs. Hinton and Taabazuing on this achievement,” said Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., Executive Vice President and President, Research & Early Development, Bristol Myers Squibb. “Partnering with organizations like the UNCF is critical because scientific discovery and advancement is dependent on diverse perspectives and experiences.”

Drs. Hinton and Taabazuing join the inaugural recipients, Bianca Jones Marlin, Ph.D. and Elizabeth Ransey, Ph.D., as E. E. Just fellows. Dr. Marlin is a neuroscientist and postdoctoral researcher at Columbia University’s Zuckerman Institute; and Dr. Ransey is a postdoctoral scientist in the Laboratory of Psychiatric Neuroengineering at Duke University. Drs. Marlin and Ransey were hosted and celebrated at the Bristol Myers Squibb Lawrenceville site in October 2019, where they showcased their research and networked with scientific leaders and mentors at the company.

“Bristol Myers Squibb has supported UNCF for many years because we know the value programs like the E. E. Just Postgraduate Fellowship can bring not only to the individual recipients, but to the community and global companies like ours,” added David L. Gonzales, Global Chief Diversity Officer, Bristol Myers Squibb. “Having critical new ideas and perspectives that are valued leads to a sense of belonging and collaboration that drives both scientific innovation and business performance. Clearly, when diversity is celebrated and inclusion is intentional, everyone wins, especially our patients.”

About the Ernest E. Just Postgraduate Fellowship Program

The Ernest E. Just Postgraduate Fellowship Program in the Life Sciences was created in 2017 as a partnership between UNCF and Bristol Myers Squibb. It aims to accelerate the career development of African American scientists pursuing research careers in academic or biopharmaceutical industry R&D. Named in honor of Dr. Ernest Everett Just, a pioneering biologist and one of the most prominent African American scientists of the twentieth century, the three-year fellowship includes a stipend, research budget, travel award for research conferences, and access to mentors and professional networks. The program also provides fellowship recipients with opportunities to engage with Bristol Myers Squibb scientists in the company’s research and early development division to learn about biopharmaceutical careers in research and translational medicine.

About UNCF

UNCF (United Negro College Fund) is the nation’s largest and most effective minority education organization. To serve youth, the community and the nation, UNCF supports students’ education and development through scholarships and other programs, strengthens its 37 member colleges and universities, and advocates for the importance of minority education and college readiness. UNCF institutions and other historically black colleges and universities are highly effective, awarding 20 percent of African American baccalaureate degrees. UNCF annually awards $100 million in scholarships and administers more than 400 programs, including scholarship, internship and fellowship, mentoring, summer enrichment, and curriculum and faculty development programs. Today, UNCF supports more than 60,000 students at more than 1,100 colleges and universities across the country. Its logo features the UNCF torch of leadership in education and its widely recognized trademark, “A mind is a terrible thing to waste.”® Learn more at UNCF.org, or for continuous news and updates, follow UNCF on Twitter, @UNCF.

About Bristol Myers Squibb

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.

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Contacts

Bristol Myers Squibb
Media Inquiries:
Media@BMS.com
609-252-3345

, , {item content}, October 2, 2020

Tags #Partnership, #Scientists, #UNCF, African-American, Bristol Myers Squibb, Ernest E. Just Postgraduate Fellowship, Life Sciences, Life Sciences#Partnership

Healthcare

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

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

Tags #Cells, #IDHIFA, Bristol Myers Squibb, Healthcare, Hematology, Leukemia, Myeloid, patients, Phase 3 IDHENTIFY, Trials, Trials#Cells

Healthcare

Bristol Myers Squibb and the Bristol Myers Squibb Foundation commit $300 million to accelerate and expand health equity and diversity and inclusion efforts

Five–year commitment builds on long-standing investment in health equity

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE: BMY) and the Bristol Myers Squibb Foundation announced today a combined investment of $300 million as part of a series of commitments. For Bristol Myers Squibb and the Bristol Myers Squibb Foundation, the commitments are designed to address health disparities, increase clinical trial diversity and for Bristol Myers Squibb, to increase the company’s spend with diverse suppliers and continue to increase Black/African American and Hispanic/Latino representation at all levels of the company. These commitments build on each entity’s experience addressing health disparities and, for Bristol Myers Squibb, its investments in increasing the diversity of its workforce.

The combined $300 million investment to health equity focuses on raising disease awareness and education, increasing health care access, and improving health outcomes for medically underserved populations. The BMS Foundation’s commitment to clinical trial diversity focuses on building clinical trial infrastructure in diverse communities and high disease burden areas in the U.S. and increasing the diversity of investigators through a fellowship program over five years.

“Our company has a long history of addressing health disparities as part of our overall mission to serve patients with serious disease,” said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol Myers Squibb. “Now more than ever, we recognize the urgent need to do more to address serious gaps in care among the underserved in communities around the world. This commitment reflects our belief that investments toward achieving health equity, and increasing diversity and inclusion are opportunities to advance our vision of transforming patients’ lives through science.”

This investment follows Bristol Myers Squibb’s previous announcement to expand its existing patient support program to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. In recent months, though, COVID-19 has exposed the severity of social and health disparities in the U.S. that increase the risk for infection and poorer health outcomes for Black/African American and Hispanic/Latino communities.

Bristol Myers Squibb and the Bristol Myers Squibb Foundation recognize the need to take concrete steps to better serve and collaborate with an increasingly diverse U.S. population and underserved communities around the world.

The commitments include:

Increasing clinical trial diversity: Bristol Myers Squibb will extend the reach of clinical trials into underserved patient communities in urban and rural U.S. geographies. The Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators who will have mentorship and training opportunities, and ultimately to enroll underserved patients into clinical trials.

“Clinical trial diversity needs acceleration. We see tremendous opportunity for longer-term, sustainable impact by supporting ethnically diverse physician scientists to engage in clinical research while also establishing clinical research sites in diverse communities,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “Over the next five years, we will extend the reach of our trials into underserved patient communities and the Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators that can enroll a diverse patient population in trials conducted across the industry.”

Strengthening health equity work across the business: Bristol Myers Squibb will accelerate its efforts to reach at-risk patients with disease awareness and education programs and information about its patient support programs, including programs for people who cannot afford their medicines. Bristol Myers Squibb will also continue to advocate for policies that promote health equity.

Increasing the company’s spend with diverse suppliers: Bristol Myers Squibb will spend $1 billion globally by 2025 with Black/African American and other diverse-owned businesses to help create jobs and generate positive economic impact in diverse communities.

Increasing the diversity of the company’s workforce: Bristol Myers Squibb will expand the diversity of its workforce and leadership to ensure it reflects the evolving demographics of the patients the company serves. The company achieved gender parity across its workforce in 2015. By 2022, Bristol Myers Squibb aims to achieve gender parity at the executive level globally; double executive representation of Black/African American employees in the U.S.; and double executive representation of Hispanic/Latino employees in the U.S.

“As a patient focused company, it is vital that our workforce reflect the people, cultures and communities we serve,” added Ann Powell, chief human resources officer, Bristol Myers Squibb. “We recognize that meeting the needs of patients means we must continue to grow a powerfully diverse, and broadly inclusive, workforce.”

Expanding our employee giving program: Bristol Myers Squibb Foundation will provide a 2-to-1 match for U.S. employee donations to organizations that fight health disparities and discrimination.

The commitments by the Bristol Myers Squibb Foundation build on the more than 100 active grantee projects funded by the Foundation globally to improve access to care and support, and health outcomes that have reached nearly 1.5 million people worldwide. For more information on these commitments and the work Bristol Myers Squibb is doing to transform patients’ lives through science, visit BMS.com.

About Bristol Myers Squibb

About the Bristol Myers Squibb Foundation

The Bristol Myers Squibb Foundation promotes health equity and seeks to improve the health outcomes of populations disproportionately affected by serious diseases by strengthening healthcare worker capacity, integrating medical care and community-based supportive services, and mobilizing communities in the fight against disease. The Foundation engages partners to develop, test, sustain and spread innovative clinic-community partnerships to help patients access care and support for cancer in the U.S., China, Africa, and Brazil and for cardiovascular diseases, multiple sclerosis, and rheumatoid arthritis in the United States. For more information about the Bristol Myers Squibb Foundation, visit us at BMS.com/Foundation.

Contacts

BRISTOL MYERS SQUIBB
Media:
609-252-3345

MEDIA@BMS.COM

Tags #BMS, Biopharmaceutical, Bristol Myers Squibb, Bristol Myers Squibb Foundation, Business, Disparities, diversity, Equity, Healthcare, Inclusion, Inclusion#BMS

Healthcare

Bristol Myers Squibb and bluebird bio announce submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for adults with relapsed and refractory multiple myeloma

BLA submission based on results from pivotal Phase 2 KarMMa study evaluating ide-cel in heavily pre-treated patient population

Companies are committed to working with the FDA to rapidly advance ide-cel through the regulatory review process

PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE)–$BLUE #BMS—Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma. This submission provides further details on the Chemistry, Manufacturing and Controls (CMC) module to address the outstanding regulatory requests from the FDA in May 2020 following the original BLA submission from March 2020.

The submission is based on results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of ide-cel in relapsed and refractory multiple myeloma patients exposed to an immunomodulatory (IMiD) agent, a proteasome inhibitor (PI) and an anti-CD38 antibody. Results from the study were shared during an oral presentation as part of the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program.¹

Multiple myeloma is a cancer of plasma cells.² The cause of multiple myeloma is not known and currently there is no cure; however, there are a number of treatment options available that can lead to response.² Patients who have already been treated with some available therapies but continue to have progression of their disease have “relapsed” and “refractory” multiple myeloma, meaning their cancer has returned after they have received initial treatments. Patients with relapsed and refractory multiple myeloma that have been exposed to all three major drug classes, including an IMiD agent, a PI and an anti-CD38 antibody, have fewer treatment options and poor outcomes, including shorter response durations and lower overall survival.³

Ide-cel was granted Breakthrough Therapy Designation (BTD) by the FDA, and PRIority MEdicines (PRIME) designation and validation of its Marketing Authorization Application (MAA) by the European Medicines Agency for relapsed and refractory multiple myeloma.

Ide-cel is not approved for any indication in any geography.

For Holders of Contingent Value Rights (CVR), Ticker BMY-RT

U.S. FDA approval of ide-cel by March 31, 2021 is one of the required remaining milestones of the Contingent Value Rights issued upon the close of the Celgene acquisition in the fourth quarter of 2019. The other is U.S. FDA approval of liso-cel by December 31, 2020. The company is committed to working with FDA to progress both applications and achieve the remaining regulatory milestones required by the CVR.

About Ide-cel

Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3-ζ chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between Bristol Myers Squibb and bluebird bio. Ide-cel was granted accelerated assessment by the European Medicines Agency (EMA) on March 26, 2020, and the MAA was validated by the EMA on May 20, 2020.

About KarMMa

KarMMa (NCT03361748) is a pivotal, open-label, single-arm, multicenter, multinational, Phase 2 study evaluating the efficacy and safety of ide-cel in adults with relapsed and refractory multiple myeloma in North America and Europe. The primary endpoint of the study is overall response rate as assessed by an independent review committee (IRC) according to the International Myeloma Working Group (IMWG) criteria. Complete response rate is a key secondary endpoint. Other efficacy endpoints include time to response, duration of response, progression-free survival, overall survival, minimal residual disease evaluated by Next-Generation Sequencing (NGS) assay and safety. The study enrolled 140 patients, of whom 128 received ide-cel across the target dose levels of 150-450 x 10⁶ CAR+ T cells after receiving lymphodepleting chemotherapy. All enrolled patients had received at least three prior treatment regimens, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and were refractory to their last regimen, defined as progression during or within 60 days of their last therapy.

Bristol Myers Squibb: Advancing Cancer Research

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 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 Bristol Myers Squibb

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, we’re developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, we’re working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. We’re putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, β-thalassemia and multiple myeloma using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

bluebird bio is a trademark of bluebird bio, Inc.

Bristol Myers Squibb 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 ide-cel, or bb2121, may not achieve its primary study endpoint or receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether 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, 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.

bluebird bio 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 ide-cel. 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 that the BLA submission may not be accepted for filing by the FDA without the provision of further information or responses to additional requests, if at all, that ide-cel may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, and, if approved, whether ide-cel will be commercially successful, that the positive results for ide-cel may not continue in additional clinical trials, and that the collaboration with Bristol Myers Squibb may not continue or be 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 bluebird bio’s business, particularly those identified in the risk factors discussion in bluebird bio’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, bluebird bio 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.

Hyperlinks are provided as a convenience and for informational purposes only. Neither Bristol Myers Squibb nor bluebird bio bears responsibility for the security or content of external websites or websites outside of their respective control.

References

Munshi NC, et al. Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): initial KarMMa results. ASCO 2020 Virtual Scientific Program. Abstract #8503.
American Cancer Society. What is Multiple Myeloma? Available at: https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed June 2020.
Jagannath S, et al. KarMMa-RW: a study of real world treatment patterns in heavily pretreated patients with relapsed and refractory multiple myeloma (RRMM) and comparison of outcomes to KarMMa. ASCO 2020 Virtual Scientific Program. Abstract #8525.