The three regulatory functions have been based mostly on interim outcomes from the pivotal, Part 3, open-label, world, randomized, managed KarMMa-3 research evaluating Abecma in contrast with normal mixture regimens. The research enrolled sufferers who have been handled with an immunomodulatory agent, a proteasome inhibitor, and daratumumab, that are probably the most generally used normal remedies in a number of myeloma. Rising use of daratumumab in frontline and early-line relapse has led to an growing unmet want for sufferers following therapy with the three most typical lessons of antimyeloma brokers, for whom there is no such thing as a clear therapy paradigm and sometimes very poor outcomes with present requirements of care. Outcomes of the KarMMa-3 research confirmed therapy with Abecma demonstrated a statistically vital and clinically significant enchancment in progression-free survival and total response price, and security outcomes have been per the well-established and customarily predictable security profile of Abecma . Primarily based on outcomes from KarMMa-3, Abecma is the primary and solely CAR T cell remedy to display superiority over normal regimens in a randomized, managed Part 3 trial designed to guage sufferers with triple-class uncovered relapsed and refractory a number of myeloma.

Please see the Vital Security Data part beneath, together with Boxed WARNINGS for Abecma relating to cytokine launch syndrome, neurologic toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome and Extended Cytopenia. Abecma can also be permitted within the European Union, Switzerland, the UK, Japan, Canada, and Israel for grownup sufferers with triple-class uncovered relapsed and/or refractory a number of myeloma after three to 4 or extra prior traces of remedy.

About KarMMa-3

KarMMa-3 (BB2121-MM-003, NCT03651128) is a pivotal, Part 3, open-label, world, randomized, managed trial evaluating Abecma in comparison with normal regimens in sufferers with relapsed and refractory a number of myeloma who’ve acquired two to 4 prior traces of therapy, together with an immunomodulatory agent, a proteasome inhibitor, and daratumumab and have been refractory to the final therapy routine. Sufferers have been randomized to obtain Abecma or normal regimens that consisted of mixtures that included daratumumab, pomalidomide, and dexamethasone (DPd), daratumumab, bortezomib, and dexamethasone (DVd), ixazomib, lenalidomide, and dexamethasone (IRd), carfilzomib and dexamethasone (Kd) or elotuzumab, pomalidomide and dexamethasone (EPd) chosen by investigators based mostly on their most up-to-date therapy routine. The first endpoint evaluated on this research is progression-free survival, outlined as time from randomization to the primary documentation of progressive illness or dying because of any trigger, whichever happens first. Key secondary endpoints embrace total response price and total survival.

About Abecma

Abecma acknowledges and binds to BCMA on the floor of a number of myeloma cells resulting in CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. Abecma is being collectively developed and commercialized within the U.S. as a part of a Co-Growth, Co-Promotion, and Revenue Share Settlement between Bristol Myers Squibb and 2seventy bio. Bristol Myers Squibb assumes sole duty for Abecma drug product manufacturing and commercialization outdoors of the U.S.

The businesses’ broad medical improvement program for Abecma consists of ongoing and deliberate medical research (KarMMa-2, KarMMa-3, KarMMa-9) in earlier traces of therapy for sufferers with a number of myeloma. For extra data go to clinicaltrials.gov .

U.S. Vital Security Data

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA

• Cytokine Launch Syndrome (CRS), together with deadly or life-threatening reactions, occurred in sufferers following therapy with ABECMA. Don’t administer ABECMA to sufferers with energetic an infection or inflammatory problems. Deal with extreme or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
• Neurologic Toxicities, which can be extreme or life-threatening, occurred following therapy with ABECMA, together with concurrently with CRS, after CRS decision, or within the absence of CRS. Monitor for neurologic occasions after therapy with ABECMA. Present supportive care and/or corticosteroids as wanted.
• Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) together with deadly and life-threatening reactions, occurred in sufferers following therapy with ABECMA. HLH/MAS can happen with CRS or neurologic toxicities.
• Extended Cytopenia with bleeding and an infection, together with deadly outcomes following stem cell transplantation for hematopoietic restoration, occurred following therapy with ABECMA.
• ABECMA is out there solely by means of a restricted program underneath a Danger Analysis and Mitigation Technique (REMS) referred to as the ABECMA REMS

WARNINGS AND PRECAUTIONS:

Cytokine Launch Syndrome (CRS): CRS, together with deadly or life-threatening reactions, occurred following therapy with ABECMA in 85% (108/127) of sufferers. Grade 3 or greater CRS occurred in 9% (12/127) of sufferers, with Grade 5 CRS reported in a single (0.8%) affected person. The median time to onset of CRS, any grade, was 1 day (vary: 1 – 23 days) and the median period of CRS was 7 days (vary: 1 – 63 days). The commonest manifestations included pyrexia, hypotension, tachycardia, chills, hypoxia, fatigue, and headache. Grade 3 or greater occasions which may be related to CRS embrace hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, acute respiratory misery syndrome (ARDS), atrial fibrillation, hepatocellular harm, metabolic acidosis, pulmonary edema, a number of organ dysfunction syndrome, and HLH/MAS.

Determine CRS based mostly on medical presentation. Consider for and deal with different causes of fever, hypoxia, and hypotension. CRS has been reported to be related to findings of HLH/MAS, and the physiology of the syndromes could overlap. In sufferers with progressive signs of CRS or refractory CRS regardless of therapy, consider for proof of HLH/MAS.

Fifty 4 p.c (68/127) of sufferers acquired tocilizumab (single dose: 35%; greater than 1 dose: 18%). Total, 15% (19/127) of sufferers acquired a minimum of 1 dose of corticosteroids for therapy of CRS. All sufferers that acquired corticosteroids for CRS acquired tocilizumab. Be certain that a minimal of two doses of tocilizumab can be found previous to infusion of ABECMA.

Monitor sufferers a minimum of every day for 7 days following ABECMA infusion on the REMS-certified healthcare facility for indicators or signs of CRS and monitor sufferers for indicators or signs of CRS for a minimum of 4 weeks after ABECMA infusion. On the first signal of CRS, institute therapy with supportive care, tocilizumab and/or corticosteroids as indicated.

Counsel sufferers to hunt fast medical consideration ought to indicators or signs of CRS happen at any time.

Neurologic Toxicities: Neurologic toxicities, which can be extreme or life-threatening, occurred following therapy with ABECMA in 28% (36/127) of sufferers receiving ABECMA, together with Grade 3 in 4% (5/127) of sufferers. One affected person had ongoing Grade 2 neurotoxicity on the time of dying. Two sufferers had ongoing Grade 1 tremor on the time of knowledge cutoff. The median time to onset of neurotoxicity was 2 days (vary: 1 – 42 days). CAR T cell-associated neurotoxicity resolved in 92% (33/36) of sufferers with a median time to decision of 5 days (vary: 1 – 61 days). The median period of neurotoxicity was 6 days (vary: 1 – 578) in all sufferers together with 3 sufferers with ongoing neurotoxicity. Thirty-four sufferers with neurotoxicity had CRS with onset in 3 sufferers earlier than, 29 sufferers throughout, and a pair of sufferers after CRS. Probably the most incessantly reported manifestations of CAR T cell-associated neurotoxicity embrace encephalopathy, tremor, aphasia, and delirium. Grade 4 neurotoxicity and cerebral edema in 1 affected person, Grade 3 myelitis, and Grade 3 parkinsonism have been reported with ABECMA in one other research in a number of myeloma.

Monitor sufferers a minimum of every day for 7 days following ABECMA infusion on the REMS-certified healthcare facility for indicators or signs of neurologic toxicities and monitor sufferers for indicators or signs of neurologic toxicities for a minimum of 4 weeks after ABECMA infusion and deal with promptly. Rule out different causes of neurologic signs. Neurologic toxicity needs to be managed with supportive care and/or corticosteroids as wanted.

Counsel sufferers to hunt fast medical consideration ought to indicators or signs happen at any time.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): HLH/MAS occurred in 4% (5/127) of sufferers receiving ABECMA. One affected person developed deadly multi-organ HLH/MAS with CRS and one other affected person developed deadly bronchopulmonary aspergillosis with contributory HLH/MAS. Three circumstances of Grade 2 HLH/MAS resolved. All occasions of HLH/MAS had onset inside 10 days of receiving ABECMA with a median onset of seven days (vary: 4 – 9 days) and occurred within the setting of ongoing or worsening CRS. Two sufferers with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS embrace hypotension, hypoxia, a number of organ dysfunction, renal dysfunction, and cytopenia. HLH/MAS is a probably life-threatening situation with a excessive mortality price if not acknowledged early and handled. Therapy of HLH/MAS needs to be administered per institutional tips.

ABECMA REMS: As a result of danger of CRS and neurologic toxicities, ABECMA is out there solely by means of a restricted program underneath a Danger Analysis and Mitigation Technique (REMS) referred to as the ABECMA REMS. Additional data is out there at www.AbecmaREMS.com or 1-888-423-5436.

Hypersensitivity Reactions: Allergic reactions could happen with the infusion of ABECMA. Critical hypersensitivity reactions, together with anaphylaxis, could also be because of dimethyl sulfoxide (DMSO) in ABECMA.

Infections: ABECMA shouldn’t be administered to sufferers with energetic infections or inflammatory problems. Extreme, life-threatening, or deadly infections occurred in sufferers after ABECMA infusion. Infections (all grades) occurred in 70% of sufferers. Grade 3 or 4 infections occurred in 23% of sufferers. Total, 4 sufferers had Grade 5 infections (3%); 2 sufferers (1.6%) had Grade 5 occasions of pneumonia, 1 affected person (0.8%) had Grade 5 bronchopulmonary aspergillosis, and 1 affected person (0.8%) had cytomegalovirus (CMV) pneumonia related to Pneumocystis jirovecii. Monitor sufferers for indicators and signs of an infection earlier than and after ABECMA infusion and deal with appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials in keeping with normal institutional tips.

Febrile neutropenia was noticed in 16% (20/127) of sufferers after ABECMA infusion and could also be concurrent with CRS. Within the occasion of febrile neutropenia, consider for an infection and handle with broad-spectrum antibiotics, fluids, and different supportive care.

Viral Reactivation : CMV an infection leading to pneumonia and dying has occurred following ABECMA administration. Monitor and deal with for CMV reactivation in accordance with medical tips. Hepatitis B virus (HBV) reactivation, in some circumstances leading to fulminant hepatitis, hepatic failure, and dying, can happen in sufferers handled with medicine directed in opposition to plasma cells. Carry out screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with medical tips earlier than assortment of cells for manufacturing.

Extended Cytopenias: Within the medical research, 41% of sufferers (52/127) skilled extended Grade 3 or 4 neutropenia and 49% (62/127) skilled extended Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 83% (43/52) of sufferers who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to restoration from ABECMA infusion was 1.9 months. In 65% (40/62) of sufferers who recovered from Grade 3 or 4 thrombocytopenia, the median time to restoration was 2.1 months.

Three sufferers underwent stem cell remedy for hematopoietic reconstitution because of extended cytopenia. Two of the three sufferers died from problems of extended cytopenia. Monitor blood counts previous to and after ABECMA infusion. Handle cytopenia with myeloid progress issue and blood product transfusion help.

Hypogammaglobulinemia: Hypogammaglobulinemia was reported as an adversarial occasion in 21% (27/127) of sufferers; laboratory IgG ranges fell beneath 500 mg/dl after infusion in 25% (32/127) of sufferers handled with ABECMA.

Monitor immunoglobulin ranges after therapy with ABECMA and administer IVIG for IgG

The protection of immunization with reside viral vaccines throughout or after ABECMA therapy has not been studied. Vaccination with reside virus vaccines isn’t beneficial for a minimum of 6 weeks previous to the beginning of lymphodepleting chemotherapy, throughout ABECMA therapy, and till immune restoration following therapy with ABECMA.

Secondary Malignancies: Sufferers handled with ABECMA could develop secondary malignancies. Monitor life-long for secondary malignancies. If a secondary malignancy happens, contact Bristol-Myers Squibb at 1-888-805-4555 to acquire directions on affected person samples to gather for testing of secondary malignancy of T cell origin.

Results on Capacity to Drive and Function Equipment: As a result of potential for neurologic occasions, sufferers receiving ABECMA are in danger for altered or decreased consciousness or coordination within the 8 weeks following ABECMA infusion. Advise sufferers to chorus from driving and fascinating in hazardous occupations or actions, reminiscent of working heavy or probably harmful equipment, throughout this preliminary interval.

Opposed Reactions: The commonest nonlaboratory adversarial reactions embrace CRS, infections – pathogen unspecified, fatigue, musculoskeletal ache, hypogammaglobulinemia, diarrhea, higher respiratory tract an infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased urge for food.

Please see full Prescribing Data , together with Boxed WARNINGS and Treatment Information .

Bristol Myers Squibb: Making a Higher Future for Folks with Most cancers

Bristol Myers Squibb is impressed by a single imaginative and prescient—remodeling sufferers’ lives by means of science. The purpose of the corporate’s most cancers analysis is to ship medicines that provide every affected person a greater, more healthy life and to make remedy a chance. Constructing on a legacy throughout a broad vary of cancers which have modified survival expectations for a lot of, Bristol Myers Squibb researchers are exploring new frontiers in customized drugs, and thru progressive digital platforms, are turning knowledge into insights that sharpen their focus. Deep scientific experience, cutting-edge capabilities and discovery platforms allow the corporate to have a look at most cancers from each angle. Most cancers can have a relentless grasp on many components of a affected person’s life, and Bristol Myers Squibb is dedicated to taking actions to handle all facets of care, from prognosis to survivorship. As a result of as a frontrunner in most cancers care, Bristol Myers Squibb is working to empower all individuals with most cancers to have a greater future.

Be taught extra in regards to the science behind cell remedy and ongoing analysis at Bristol Myers Squibb right here .

About Bristol Myers Squibb

Bristol Myers Squibb is a world biopharmaceutical firm whose mission is to find, develop and ship progressive medicines that assist sufferers prevail over critical illnesses. For extra details about Bristol Myers Squibb, go to us at BMS.com or observe us on LinkedIn , Twitter , YouTube , Fb and Instagram .

About 2seventy bio

Our identify, 2seventy bio, displays why we do what we do – TIME. Most cancers rips time away, and our purpose is to work on the most velocity of translating human thought into motion – 270 miles per hour – to provide the individuals we serve extra time. We’re constructing the main immuno-oncology cell remedy firm, targeted on discovering and growing new therapies that actually disrupt the most cancers therapy panorama. With a deep understanding of the human physique’s immune response to tumor cells and the way to translate cell therapies into observe, we’re making use of this data to ship subsequent technology mobile therapies that concentrate on a broad vary of hematologic malignancies, together with the primary FDA-approved CAR T cell remedy for a number of myeloma, in addition to strong tumors. Our analysis and improvement are targeted on delivering therapies which might be designed with the purpose to “assume” smarter and sooner than the illness. Importantly, we stay targeted on carrying out these objectives by staying real and genuine to our “why” and protecting our individuals and tradition prime of thoughts day by day.

For extra data, go to www.2seventybio.com .

Comply with 2seventy bio on social media: Twitter and LinkedIn .

2seventy bio is a trademark of 2seventy bio, Inc.

Bristol Myers Squibb Cautionary Assertion Relating to Ahead-Wanting Statements

This press launch accommodates “forward-looking statements” throughout the that means of the Non-public Securities Litigation Reform Act of 1995 relating to, amongst different issues, the analysis, improvement and commercialization of pharmaceutical merchandise. All statements that aren’t statements of historic information are, or could also be deemed to be, forward-looking statements. Such forward-looking statements are based mostly on present expectations and projections about our future monetary outcomes, objectives, plans and aims and contain inherent dangers, assumptions and uncertainties, together with inside or exterior components that would delay, divert or change any of them within the subsequent a number of years, which might be troublesome to foretell, could also be past our management and will trigger our future monetary outcomes, objectives, plans and aims to vary materially from these expressed in, or implied by, the statements. These dangers, assumptions, uncertainties and different components embrace, amongst others, that future research outcomes might not be per the outcomes thus far, that Abecma ^® (idecabtagene vicleucel) could not obtain regulatory approval for the extra indication described on this launch within the presently anticipated timeline or in any respect, that any advertising and marketing approvals, if granted, could have vital limitations on their use, and, if permitted, whether or not such product candidate for such extra indication described on this launch can be commercially profitable . No forward-looking assertion might be assured. It also needs to be famous that acceptance of the sBLA doesn’t change the requirements for FDA approval, that validation by the EMA of the appliance doesn’t change the requirements for EMA approval, and that acceptance of the sNDA doesn’t change the requirements for Japan’s Ministry of Well being, Labour and Welfare approval. Ahead-looking statements on this press launch needs to be evaluated along with the numerous dangers and uncertainties that have an effect on Bristol Myers Squibb’s enterprise and market, significantly these recognized within the cautionary assertion and danger components dialogue in Bristol Myers Squibb’s Annual Report on Kind 10-Ok for the yr ended December 31, 2022, as up to date by our subsequent Quarterly Stories on Kind 10-Q, Present Stories on Kind 8-Ok and different filings with the Securities and Alternate Fee. The forward-looking statements included on this doc are made solely as of the date of this doc and besides as in any other case required by relevant legislation, Bristol Myers Squibb undertakes no obligation to publicly replace or revise any forward-looking assertion, whether or not on account of new data, future occasions, modified circumstances or in any other case.

2seventy bio Cautionary Notice Relating to Ahead-Wanting Statements

This press launch accommodates “forward-looking statements” throughout the that means of the Non-public Securities Litigation Reform Act of 1995 relating to, amongst different issues, the analysis, improvement and commercialization of Abecma ^® (idecabtagene vicleucel). All statements that aren’t statements of historic information are, or could also be deemed to be, forward-looking statements. Such forward-looking statements are based mostly on historic efficiency and present expectations and projections about our future monetary outcomes, objectives, plans and aims and contain inherent dangers, assumptions and uncertainties, together with inside or exterior components that would delay, divert or change any of them within the subsequent a number of years, which might be troublesome to foretell, could also be past our management and will trigger our future monetary outcomes, objectives, plans and aims to vary materially from these expressed in, or implied by, the statements. These dangers, assumptions, uncertainties and different components embrace, amongst others, the chance that Abecma could not obtain FDA approval for the indication described on this launch within the presently anticipated timeline or in any respect, that any advertising and marketing approvals, if granted, could have vital limitations on their use, that Abecma might not be commercially profitable and that collaboration with Bristol Myers Squibb could not proceed or achieve success. No forward-looking assertion might be assured. Ahead-looking statements on this press launch needs to be evaluated along with the numerous dangers and uncertainties that have an effect on 2seventy bio’s enterprise, significantly these recognized within the danger components dialogue in 2seventy bio’s Annual Report on Kind 10-Ok, as up to date by our subsequent Quarterly Stories on Kind 10-Q, Present Stories on Kind 8-Ok and different filings with the Securities and Alternate Fee. The forward-looking statements included on this doc are made solely as of the date of this doc and besides as in any other case required by relevant legislation, 2seventy bio undertakes no obligation to publicly replace or revise any forward-looking assertion, whether or not on account of new data, future occasions, modified circumstances or in any other case.

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