The Norwegian Immunotherapy in Multiple Myeloma Study - A Population-based Longitudinal Observational Multicenter Study on Effectiveness and Complications of Immunotherapy in Multiple Myeloma in the Norwegian Myeloma Cohort

The goal of this observational study is to study the effectiveness and complications of novel immunotherapies used in the treatment of multiple myeloma in routine care in Norway. The aim is to close knowledge gaps, generate evidence for future clinical trials and contribute to future consensus on how to monitor for adverse events, and what mitigation strategies should be implemented, so that we can increase patient survival and quality-of-life.

开始日期2025-01-15

申办/合作机构

St. Olavs Hospital HF

[+11]

NCT06698887

/ RecruitingN/A

Long-Term Safety Follow-Up Surveillance for Phase 3 Trial (KarMMA-9/CA089-1043) to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

The purpose of this study is to monitor the long-term safety of participants who received idecabtagene vicleucel treatment as part of the KarMMa-9 (CA089-1043) Phase 3 clinical trial.

开始日期2024-09-11

申办/合作机构

Bristol Myers Squibb Co.

CTIS2022-501346-30-00

/ Not yet recruiting临床3期

A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel with Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants with Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation - CA089-1043

开始日期2023-10-16

申办/合作机构

Celgene Corp.

100 项与艾基维仑赛相关的临床结果

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100 项与艾基维仑赛相关的转化医学

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100 项与艾基维仑赛相关的专利（医药）

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157

项与艾基维仑赛相关的文献（医药）

2025-04-01·CYTOTHERAPY

Severe hypophosphatemia following idecabtagene vicleucel regardless of the severity of cytokine release syndrome

Article

作者: Asada, Noboru ; Kobayashi, Hiroki ; Fujiwara, Hideaki ; Hayashino, Kenta ; Fujii, Nobuharu ; Maeda, Yoshinobu ; Kitamura, Wataru ; Kamoi, Chihiro ; Fujii, Keiko ; Kondo, Takumi ; Ennishi, Daisuke ; Terao, Toshiki ; Seike, Keisuke

BACKGROUND AIMS:

Hypophosphatemia has been recently recognized adverse event in chimeric antigen receptor (CAR)-T cell therapy, complicating 70-75% of patients. Severe hypophosphatemia can cause cytokine release syndrome (CRS)-like symptoms, such as respiratory and cardiovascular dysfunction. Some reports have described the association between inorganic phosphate (iP) and CRS in patients treated with tisagenlecleucel (tisa-cel), lisocabtagene maraleucel (liso-cel), axicabtagene ciloleucel (axi-cel). However, the association between iP and idecabtagene vicleucel (ide-cel) has not been reported and the kinetics of serum iP for each CAR-T cell product have not been compared. We aimed to analyze the kinetics of iP with CAR-T cell products, including ide-cel, and the association between hypophosphatemia and severe CRS.

METHODS:

We retrospectively analyzed patients aged ≥ 18 years with B-cell malignancies who received CAR-T cell therapy in our institution. All available laboratory data were collected for 21 days after CAR-T cell infusion; clinical and laboratory data were extracted from electronic medical records.

RESULTS:

A total of 108 patients were treated with CAR-T cell therapy (tisa-cel, n = 56; liso-cel, n = 11; axi-cel, n = 28; ide-cel, n = 13). The cumulative incidence of hypophosphatemia and severe hypophosphatemia were significantly higher in the ide-cel group than the other CAR-T products group (92.3% versus 67.5%, P = 0.0045, and 15.4% versus 2.1%, P = 0.017), Patients treated with ide-cel had significantly lower serum iP levels from day -4 to 8 compared to other CAR-T products. As previous reports, the cumulative incidence of hypophosphatemia in the other CAR-T products group was significantly higher in the severe CRS group than in the mild CRS group (84.0% versus 60.0%, P = 0.0002). In contrast, there was no significant difference between the two groups in the ide-cel group (65% versus 100%, P = 0.13).

CONCLUSION:

Our results suggest that and that it is important to monitor iP kinetics more carefully because patients treated with ide-cel complicate severe hypophosphatemia, regardless of CRS severity.

2025-03-11·Blood Advances

BCMA-directed CAR T-cell therapy in patients with multiple myeloma and CNS involvement

Article

作者: Hansen, Doris K. ; Gaballa, Mahmoud R. ; Cohen, Adam ; Ferreri, Christopher J. ; Chung, Alfred ; Puglianini, Omar Castaneda ; Patel, Krina K. ; Voorhees, Peter ; Vogl, Dan

Abstract:

We investigated B-cell maturation antigen-directed chimeric antigen receptor T-cell (CAR-T) therapy in patients with relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) involvement. Ten patients received either idecabtagene vicleucel (n = 6) or ciltacabtagene autoleucel (n = 4), where brain/cranial nerve and/or spinal cord involvement/leptomeningeal disease were evident on either magnetic resonance imaging (100%) and/or cerebrospinal fluid (40%). Eight patients had their CNS diagnosis before CAR-T therapy, and two were diagnosed within 14 days post-infusion. Seven received CNS-directed therapy during bridging before CAR-T therapy. There were no excess toxicities: no cytokine release syndrome grade ≥3; 10% immune effector cell-associated neurotoxicity syndrome (ICANS) grade 3; and no ICANS grade 4. Two patients experienced delayed but treatable neurotoxicity, with no reported parkinsonian side effects. The best overall response rate was 80% (≥70% very good partial response) and a 100% CNS response. With a median follow-up of 381 days, patients with CNS myeloma diagnosed before CAR-T therapy (n = 8) had a median overall survival and progression-free survival (PFS) of 13.3 and 6.3 months, respectively. Best outcomes were observed in 4 patients who had a response to bridging therapy, suggesting that optimizing pre-CAR-T therapy may be key for improved outcomes. Our study suggests that CAR-T therapy in patients with CNS MM is safe and feasible, and screening for CNS involvement before CAR-T therapy could be warranted in high-risk patients. The excellent initial response but relatively short PFS suggests consideration for post-CAR-T maintenance. Larger studies are needed to confirm these findings.

2025-03-01·BRITISH JOURNAL OF HAEMATOLOGY

Update on B‐cell maturation antigen‐directed therapies in AL amyloidosis

Review

作者: Khwaja, Jahanzaib ; Zielonka, Klaudia ; Wechalekar, Ashutosh D. ; Jamroziak, Krzysztof

Summary:

Systemic light chain (AL) amyloidosis is a rare clonal plasma cell disorder characterized by the production of amyloidogenic immunoglobulin light chains, which causes the formation and deposition of amyloid fibrils, leading to multi‐organ dysfunction. Current treatment is directed at the underlying plasma cell clone to achieve a profound reduction in the monoclonal free light chain production. The standard‐of‐care first‐line therapy is a combination of daratumumab, cyclophosphamide, bortezomib and dexamethasone (D‐VCd regimen), resulting in high rates of haematological and organ responses. However, AL amyloidosis remains incurable, and all patients inevitably relapse. Hence, novel treatment options are needed for patients with an inadequate response or relapsed/refractory disease. B‐cell maturation antigen (BCMA) is a tumour necrosis factor (TNF receptor superfamily receptor overexpressed on plasma cells in multiple myeloma (MM) and AL amyloidosis. Recently, several novel anti‐BCMA immunotherapies have been approved for the treatment of relapsed/refractory MM, including antibody–drug conjugate belantamab mafodotin, bispecific antibodies teclistamab and elranatamab and chimeric antigen receptor T‐cell therapies idecabtagene vicleucel and ciltacabtagene autoleucel. Despite lower expression than in MM, BCMA is also a promising target in AL amyloidosis. This review aims to provide up‐to‐date information on the efficacy and toxicity of anti‐BCMA therapy in AL amyloidosis.

683

项与艾基维仑赛相关的新闻（医药）

2025-03-24

·PRNewswire

CARVYKTI Continued Performance Reflects Growing Confidence in CAR-T Therapies for Multiple Myeloma | DelveInsight

As a BCMA-targeting CAR T-cell therapy, CARVYKTI addresses a high unmet need in relapsed or refractory multiple myeloma patients. With promising clinical efficacy, durable responses, and growing adoption in advanced treatment lines, CARVYKTI is poised for substantial revenue growth. LAS VEGAS, March 24, 2025 /PRNewswire/ -- DelveInsight's " CARVYKTI Market Size, Forecast, and Market Insight Report" highlights the details around CARVYKTI, a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient's T cells with a transgene encoding a CAR that identifies and eliminates cells that express BCMA. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of CARVYKTI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Janssen's CARVYKTI (ciltacabtagene autoleucel) Overview CARVYKTI is an autologous T-cell immunotherapy that targets B-cell maturation antigen (BCMA). It works by genetically modifying a patient's T cells with a transgene that encodes a chimeric antigen receptor (CAR). This CAR helps the T cells recognize and destroy cells expressing BCMA, which is primarily found in malignant multiple myeloma B-lineage cells, late-stage B cells, and plasma cells. The CARVYKTI CAR protein includes two single-domain antibodies designed to bind strongly to human BCMA, enhancing T-cell activation, proliferation, and the destruction of target cells upon binding. Currently, CAR-T cell therapies are only available to UK patients through clinical trials. Janssen recently decided not to proceed with seeking approval for cilta-cel (CARVYKTI) for myeloma patients in the UK through the National Institute for Health and Care Excellence (NICE). This decision means cilta-cel will not be available on the NHS for now, although it remains accessible through clinical trials. Janssen's decision does not impact ongoing trials. The drug is currently being evaluated in Phase III trials: CARTITUDE-6 for frontline multiple myeloma transplant eligible vs ASCT and CARTITUDE-5 for frontline multiple myeloma TNI. In 2024, CARVYKTI generated sales of USD 963 million across the world. CARVYKTI Dosage and Administration CARVYKTI is administered as a single infusion containing a suspension of CAR-positive, viable T cells in one infusion bag. The recommended dosage ranges from 0.5 to 1.0 × 10⁶ CAR-positive viable T cells per kilogram of body weight, with a maximum limit of 1 × 10⁸ CAR-positive viable T cells per infusion. Learn more about CARVYKTI projected market size for multiple myeloma @ CARVYKTI Market Potential CAR-T cell immunotherapy is emerging as a revolutionary treatment for multiple myeloma, offering new hope to patients who have exhausted conventional treatment options. Currently, only two CAR-T cell therapies are approved for multiple myeloma: ABECMA (idecabtagene vicleucel) from Bristol-Myers Squibb and CARVYKTI (ciltacabtagene autoleucel) from Johnson & Johnson Innovative Medicine. Their approval highlights the potential of CAR-T therapy to transform multiple myeloma treatment. A key advantage of CAR-T therapies is their "one-and-done" nature, requiring a single administration, unlike bispecific antibodies such as TECVAYLI and TALVEY, which need ongoing dosing. Present CAR-T therapies use a patient's own T cells (autologous), but research is underway to develop allogeneic CAR-T cells derived from healthy donors. Allogeneic therapies could offer off-the-shelf solutions, enhancing accessibility and lowering costs. The approval of CAR-T therapies has created new opportunities for companies focused on advanced-stage multiple myeloma (fourth line and beyond). Several companies are progressing with their CAR-T candidates at different stages of development. The CAR-T cell therapy market for multiple myeloma is expected to grow significantly between 2024 and 2034, driven by its high efficacy and potential for expanded use. Collaboration between pharmaceutical companies and research institutions, along with ongoing innovation, is expected to accelerate market growth. However, challenges such as manufacturing complexity and pricing will need to be addressed to unlock the full potential of CAR-T therapies. Discover more about the CAR T-cell therapy for multiple myeloma market in detail @ CAR T-cell Therapy for Multiple Myeloma Market Report Emerging Competitors of CARVYKTI Some of the CAR-Ts in the multiple myeloma pipeline that will give fierce competition to CARVYKTI include Anito-cel (Arcellx), PHE885 (Novartis), BMS-986393 (Bristol-Myers Squibb), Zevorcabtagene Autoleucel (CARsgen Therapeutics), and GLPG5301 (Galapagos), among others In December 2024, Arcellx announced encouraging new data from its Phase II pivotal iMMagine-1 trial for anito-cel in multiple myeloma. The results were presented during an oral session at the 66th American Society of Hematology (ASH) Annual Meeting on Monday, December 9, 2024, at 5:30 p.m. PT. Also at ASH 2024, BMS shared the first overall survival (OS) and progression-free survival (PFS) results for arlo-cel in an oral presentation. The Phase I trial involved patients with relapsed or refractory multiple myeloma who had previously undergone at least three treatments, including a proteasome inhibitor, an immunomodulatory drug, and anti-CD38 therapy. Among 79 patients evaluable for efficacy, with a median follow-up of 16.1 months (range: 2.8–25.2), arlo-cel showed an overall response rate (ORR) of 87%, indicating durable responses. Minimal residual disease (MRD) was assessed as an exploratory measure, with 57% (48 of 84) of MRD-evaluable patients included. Of these, 46% (22 of 48) were MRD-negative and achieved a complete response (CR) or stringent CR (sCR). Across all treated patients, 27% (23 of 84) were MRD-negative and achieved a CR. Median PFS was 18.3 months (95% CI: 11.8–21.9), while the median OS had not yet been reached. To know more about the number of competing drugs in development, visit @ CARVYKTI Market Positioning Compared to Other Drugs Key Milestones of CARVYKTI In April 2024, Johnson & Johnson announced that the US FDA approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. In March 2024, Johnson & Johnson announced that the US FDA Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who are refractory to lenalidomide. In February 2024, Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended the approval of a Type II variation for CARVYKTI for the earlier treatment of RRMM. In September 2022, Legend Biotech announced that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved CARVYKTI (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma, limited to cases meeting both of the following conditions including patients having no history of CAR-positive T-cell infusion therapy targeting BCMA and patients who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy. In May 2022, Janssen announced that the European Commission (EC) granted conditional marketing authorization for CARVYKTI for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. In February 2022, Janssen announced that the US FDA had approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. In August 2020, Legend Biotech announced that the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) had recommended BTD for ciltacabtagene autoleucel (cilta-cel; LCAR-B38M CAR-T cells) for the treatment of adults with relapsed or refractory multiple myeloma. In December 2019, Janssen announced receipt of a BTD from the US FDA for cilta-cel. In April 2019, the EMA granted a PRIME (PRIority MEdicines) designation for the company's investigational BCMA CAR-T therapy. In February 2019, the US FDA granted ODD for cilta-cel (JNJ-4528), and in February 2020, the European Commission also granted orphan designation for this drug. In December 2017, Janssen entered a worldwide collaboration and license agreement with Legend Biotech to jointly develop and commercialize LCAR-B38M in multiple myeloma Discover how CARVYKTI is shaping the multiple myeloma treatment landscape @ CARVYKTI CAR-T CARVYKTI Market Dynamics The market for CARVYKTI is driven by the increasing prevalence of multiple myeloma and the growing demand for innovative therapies that can address the limitations of existing treatments, such as proteasome inhibitors and immunomodulatory drugs. The competitive landscape includes other BCMA-targeting therapies, such as Bristol Myers Squibb's ABECMA (idecabtagene vicleucel), which was the first BCMA-directed CAR-T therapy approved for multiple myeloma. CARVYKTI's strong clinical efficacy, coupled with its potential for long-term remission, gives it a competitive edge, but challenges related to manufacturing scalability, logistical complexities, and high treatment costs could impact its market penetration and patient accessibility. Strategic partnerships and ongoing clinical development will play a key role in expanding CARVYKTI's market reach. Janssen and Legend Biotech are actively working to improve manufacturing processes to reduce vein-to-vein time and address supply chain bottlenecks. Furthermore, ongoing trials, such as CARTITUDE-4, are exploring CARVYKTI's use in earlier lines of therapy, which could significantly expand its patient base and market potential. If successful in earlier settings, CARVYKTI could shift the treatment paradigm for multiple myeloma and increase adoption among physicians and healthcare providers. Despite its promising clinical profile, CARVYKTI faces challenges related to reimbursement and healthcare infrastructure. The high cost of CAR-T therapies often limits patient access, particularly in markets with strict reimbursement policies. Moreover, the complex nature of CAR-T administration, which requires specialized centers and trained personnel, adds to the barriers. However, continued clinical success, regulatory support, and improvements in manufacturing and delivery infrastructure could strengthen CARVYKTI's market position and establish it as a cornerstone therapy in the multiple myeloma treatment landscape. Dive deeper to get more insight into CARVYKTI's strengths & weaknesses relative to competitors @ CARVYKTI Market Drug Report Table of Contents Related Reports Relapsing Refractory Multiple Myeloma Market Relapsing Refractory Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key RRMM companies including AbbVie, Genentech, Amgen, Onyx Therapeutics Inc., Bristol-Myers Squibb, MedImmune LLC, Novartis Pharmaceuticals, Incyte Corporation, Takeda, among others. Relapsing Refractory Multiple Myeloma Pipeline Relapsing Refractory Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RRMM companies, including Bristol-Myers Squibb, I-MAB Biopharma, Pfizer, Arcellx, Gilead Sciences, Novartis, Array Biopharma, Hrain Biotechnology Co., Ltd., Cartesian Therapeutics, Xencor, Takeda, Sorrento Therapeutics, Heidelberg Pharma AG, Ichnos Sciences, Allogene Therapeutics, Harpoon Therapeutics, Cellectis, Poseida Therapeutics, Regeneron Pharmaceuticals, ONK Therapeutics, TeneoOne, iTeos Therapeutics, Oricell Therapeutics, Anaveon AG, Luminary Therapeutics, Seagen Inc., Trillium Therapeutics Inc., Virtuoso BINco, Inc., Seagen Inc., Trillium Therapeutics Inc., among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies including Sanofi, Karyopharm Therapeutics, AbbVie, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. Multiple Myeloma Pipeline Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple myeloma companies, including CASI Pharmaceuticals, Carsgen Therapeutics, Cartesian Therapeutics, Gracell Biotechnology Shanghai Co., Ltd., Sorrento Therapeutics, TeneoOne, Karyopharma Therapeutics, Arcellx, Poseida Therapeutics, Ichnos Sciences, Nerviano Medical Sciences, Bristol Myers Squib, Ascentage Pharma, Ionis Pharmaceuticals, Chongqing Precision Biotech Co., Ltd., CRISPR Therapeutics, AstraZeneca, IGM Biosciences, Novartis, GlaxoSmithKline, Innovent Biologics, Keymed Biociences, Starton Therapeutics, Takeda, Fate Therapeutics, Gilead Sciences, Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., Janssen Pharmaceutical, Nanjing IASO Biotechnology Co., Ltd., GPCR Therapeutics, Chimerix, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果免疫疗法孤儿药上市批准临床3期

2025-03-11

·生物制品圈

2.86 亿美元！CAR-T 巨头 BMS 吞并 2seventy bio，行业洗牌加速

2025 年 3 月 10 日，生物医药行业迎来重磅交易 —— 百时美施贵宝（Bristol Myers Squibb, BMS）宣布以 2.86 亿美元收购 2seventy bio，这一全现金交易不仅标志着双方长达四年的合作关系进入新阶段，更折射出 CAR-T 疗法赛道的激烈竞争与行业整合趋势。交易核心条款：溢价收购与战略协同根据协议，BMS 将以每股 5 美元的价格收购 2seventy bio 全部流通股，较后者 3 月 7 日收盘价溢价 88%。交易预计于 2025 年第二季度完成，尚需通过反垄断审查及股东批准。值得注意的是，2seventy bio 的董事会已全票通过该协议，且持有 5.3% 股份的主要股东已签署支持协议。 2seventy bio 的核心资产 ABECMA 是全球首个获批的 BCMA 靶向 CAR-T 疗法，用于治疗复发 / 难治性多发性骨髓瘤。2024 年，ABECMA 全球销售额达 4.06 亿美元，其中 BMS 向 2seventy bio 支付了利润分成。此次收购后，BMS 将全资拥有 ABECMA，并承担其全球商业化责任，这一举措被视为 BMS 削减未来成本、提升利润空间的关键一步。2seventy bio 的转型之路：从独立到被收购 2seventy bio 的前身是蓝鸟生物（bluebird bio）的 CAR-T 部门，2021 年通过 SPAC 上市后独立运营。其成立初期聚焦 ABECMA 的开发与商业化，并在 2024 年推动该疗法适应症扩展至二线治疗。然而，公司面临严峻的财务压力：2023 年净亏损达 3.2 亿美元，2024 年进一步扩大至 4.1 亿美元。为缓解资金压力，2seventy bio 于 2024 年 1 月以 5000 万美元的低价将非 ABECMA 管线出售给再生元，同时裁员 30%。公司 CEO Chip Baird 在声明中表示，此次收购是 “战略聚焦的必然结果”。自 2024 年宣布专注 ABECMA 以来，2seventy bio 的市值已蒸发超 60%。分析认为，BMS 的收购为其股东提供了退出机会，同时避免了公司因资金链断裂而面临的潜在风险。BMS 的战略考量：应对专利悬崖与强化管线 BMS 此次收购正值其面临专利到期的关键时期。2025 年起，其明星产品 Yervoy（伊匹木单抗）和 Opdivo（纳武利尤单抗）将逐步失去专利保护，而 2026 年 Eliquis（阿哌沙班）的专利到期预计将导致年销售额减少超 130 亿美元。在此背景下，BMS 亟需通过并购补充高潜力产品。 ABECMA 的纳入对 BMS 的肿瘤管线形成重要补充。目前，BMS 的 CAR-T 产品组合包括针对 B 细胞淋巴瘤的 Breyanzi 和此次收购的 ABECMA。通过整合 2seventy bio 的技术团队与临床开发资源，BMS 计划加速 ABECMA 在多发性骨髓瘤早期治疗中的研究，并探索其与其他疗法的联合应用。此外，BMS 的成本优化策略也推动了此次收购。自 2024 年启动 “战略生产力计划” 以来，公司已裁员 2200 人，并将 2027 年成本削减目标提升至 20 亿美元。通过全资控股 ABECMA，BMS 预计每年可节省数亿美元的利润分成支出。行业影响：CAR-T 领域的整合加速此次收购反映了 CAR-T 疗法行业的两大趋势：一是头部企业通过并购完善产品线，二是中小型公司因资金压力寻求战略退出。目前，全球 CAR-T 市场由诺华、吉利德（Kite Pharma）和 BMS 主导，但随着更多疗法获批及适应症扩展，市场竞争日益激烈。对于患者而言，BMS 的资源投入可能加速 ABECMA 的可及性提升。目前，ABECMA 通过受限的 REMS 计划供应，BMS 计划扩大其生产规模，并探索降低治疗成本的可能性。然而，行业专家指出，CAR-T 疗法的高定价（ABECMA 在美国的定价为 41.95 万美元）仍是普及的主要障碍。风险与挑战尽管交易前景乐观，但仍存在潜在风险。反垄断审查可能成为关键障碍，尤其是在 BMS 已拥有 Breyanzi 的情况下，需证明收购不会削弱市场竞争。此外，整合过程中的文化差异及人才流失风险也不容忽视。2seventy bio 的团队在 CAR-T 领域拥有独特经验，如何保留核心员工并实现技术协同将是 BMS 面临的重要挑战。未来展望随着 BMS 完成对 2seventy bio 的收购，其在 CAR-T 领域的话语权进一步增强。市场预计，BMS 将继续通过并购或合作扩展其细胞与基因治疗布局，尤其是在实体瘤领域寻求突破。对于整个行业而言，此次交易为中小型生物科技公司提供了退出路径，同时也促使企业重新评估自身在高度资本密集型领域的可持续发展策略。未来，CAR-T 疗法的竞争将聚焦于疗效优化、成本控制及适应症拓展，而行业整合也将持续深化。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

并购细胞疗法免疫疗法财报

2025-03-11

·医药地理

BMS收购CAR-T公司2seventy bio

3月10日，CAR-T细胞疗法公司2seventy bio（由bluebird bio拆分而来）宣布被BMS以每股5.00美元的价格收购其所有流通股份，股本总价值约为2.86亿美元。与2025年3月7日的收盘价（每股2.66美元）相比，这笔交易溢价88%。交易预计将在2025年第二季度完成。依照协议规定，BMS会立刻启动一项收购要约，计划以每股5.00美元的现金价格购买2seventy bio公司所有尚未发行的股份。2seventy bio的董事会已经全票通过，建议公司股东在此次收购要约中出售他们持有的股份。收购要约成功结束后，BMS计划通过第二步的合并程序，继续以每股5.00美元的价格收购那些在收购要约期间未被提交的2seventy bio普通股剩余股份。一旦交易完成，2seventy bio的普通股将不再于纳斯达克交易所进行交易。为了确保合并协议的顺利执行，部分持有2seventy bio约5.3%流通股的股东已经根据协议签署了收购和支持协议，同意在收购中转让他们持有的所有股份。目前，2seventy bio的产品线中包括数种CAR-T细胞疗法，其中Abecma（idecabtagene vicleucel）是与BMS合作开发和推广的，该产品已于2021年获得批准并上市。到目前为止，Abecma已在全球范围内被批准作为治疗多发性骨髓瘤患者的三线、四线或五线治疗方案。根据BMS的财务报告，2024年Abecma的销售额达到了4.06亿美元。 2seventy bio的CEO Chip Baird表示：“大约一年前，2seventy bio决定集中精力开发Abecma的潜力，我们的目标是为多发性骨髓瘤患者延长生存期，并为所有利益相关方创造最大的价值。此次收购的战略意义是显而易见的，今天的声明标志着2seventy bio发展的一个阶段的结束。我们相信，在BMS的经验和资源的支持下，Abecma的推广工作将继续取得成功，确保这种关键的疗法能够到达需要它的患者手中。我想对2seventy bio现在的和曾经的团队成员，以及更广泛的致力于患者、科学家、服务提供者和合作伙伴的社区表达我深深的感谢，感谢他们帮助将细胞和基因疗法从理论转化为患者的实际治疗方案。” END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

细胞疗法并购免疫疗法基因疗法

100 项与艾基维仑赛相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11556	-	L01XX	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
多发性骨髓瘤	美国	Celgene Corp.	2021-03-03

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
复发性多发性骨髓瘤	临床3期	美国	2seventy Bio, Inc.	2022-01-30
复发性多发性骨髓瘤	临床3期	美国	中美上海施贵宝制药有限公司	2022-01-30
BCMA阳性多发性骨髓瘤	临床1期	美国	bluebird bio, Inc.	2015-12-22
BCMA阳性多发性骨髓瘤	临床1期	美国	Celgene Corp.	2015-12-22

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


3791CAR-T (ASH2024) 人工标引	N/A	多发性骨髓瘤	-	Ide-cel	齋餘網廠鹹衊淵鹹鬱艱(繭簾蓋鑰製選繭廠鹹齋) = 鑰餘選鏇構願網夢製壓膚憲齋廠網醖鹽鏇願觸 (糧膚糧衊簾鹹膚遞築積 ) 更多	相似	2024-12-08
				Cilta-cel	齋餘網廠鹹衊淵鹹鬱艱(繭簾蓋鑰製選繭廠鹹齋) = 襯壓範憲範積衊獵網餘膚憲齋廠網醖鹽鏇願觸 (糧膚糧衊簾鹹膚遞築積 ) 更多
ASCO2024	N/A	多发性骨髓瘤	351	idecabtagene vicleucel (Extramedullary disease (EMD))	簾鑰鏇鏇糧壓憲膚繭窪(構積積蓋夢鑰鹹壓築繭) = 夢齋壓夢築窪襯鹽廠築鑰夢鬱餘網鹹繭繭積鹹 (製蓋衊壓願齋壓製構顧 ) 更多	不佳	2024-05-24
				idecabtagene vicleucel (Non-EMD)	簾鑰鏇鏇糧壓憲膚繭窪(構積積蓋夢鑰鹹壓築繭) = 夢顧鑰製壓獵願鑰窪糧鑰夢鬱餘網鹹繭繭積鹹 (製蓋衊壓願齋壓製構顧 ) 更多
ASCO2024	N/A	复发性多发性骨髓瘤	-	ide-cel	衊醖範鑰襯膚夢築蓋願(齋觸遞廠鑰鏇餘鏇鏇鬱) = 廠繭簾範齋繭憲網齋衊繭齋獵壓網蓋鬱繭醖淵 (淵夢淵壓餘壓選顧壓齋 ) 更多	-	2024-05-24
NCT03601078 (KarMMa-2, EHA 12024 \| EHA 22024) 人工标引	临床2期	复发性慢性淋巴细胞白血病 \| 难治性慢性淋巴细胞白血病二线	35	Idecabtagene vicleucel	醖醖醖觸襯蓋鹹憲顧繭(膚艱顧餘鏇築淵壓積網) = 遞獵簾簾蓋獵淵窪餘淵憲鏇鏇積糧築鏇憲衊鑰 (齋積壓網遞窪網製積憲, 52 ~ 86) 更多	积极	2024-05-14
EHA2024	N/A	多发性骨髓瘤 sBCMA \| circulating EVs	19	PHE885	顧繭製餘糧繭選艱膚窪(艱艱獵鑰蓋憲積壓願膚) = The presence of BCMA was observed and quantified in circulating EVs (these EVs were characterized by canonical EV-associated proteins). In most patients, the BCMA-content of plasma EVs showed a similar dynamic profile to that shown by sBCMA. 餘網鹽蓋繭願壓壓願範 (廠糧艱憲築觸鑰鬱範簾 ) 更多	-	2024-05-14
				ARI0002h
CIBMTR Registry (EHA2024)	N/A	多发性骨髓瘤	817	IDECABTAGENE VICLEUCEL (IDE-CEL) (Very Good Partial Response (VGPR) or better)	鑰壓構衊簾鹹蓋範膚獵(簾壓顧網壓構簾觸鬱糧) = observed in SD and PD groups 鹹艱製窪製鬱醖廠顧餘 (襯膚糧夢夢餘膚觸齋範 ) 更多	积极	2024-05-14
				IDECABTAGENE VICLEUCEL (IDE-CEL) (Stable Disease (SD) or Progressive Disease (PD))
DESCAR-T \| IFM STUDY (EHA2024)	N/A	复发性多发性骨髓瘤 HRCAs \| EMD	435	idecabtagene vicleucel (ide-cel)	簾膚餘鹹範膚願糧鹽壓(積鑰鹹醖膚襯餘鑰簾壓) = 襯膚願簾齋範艱遞築衊願鹹糧齋壓鏇憲網鹽衊 (獵艱構簾網鬱鑰積鹽淵, 5.3 ~ NR)	积极	2024-05-14
				BsAb (bispecific antibody)	窪餘膚繭窪廠顧夢簾積(壓憲窪遞糧壓繭蓋淵襯) = 廠選膚夢築鏇鹽顧獵構繭襯齋鏇顧願鑰鹹鹽範 (夢繭壓憲衊積簾選選鬱 ) 更多
NCT03651128 (KarMMa-3, Pubmed) 人工标引	临床3期	多发性骨髓瘤	-	ide-cel	衊觸簾觸網顧願積鹽衊(網獵觸遞積簾製鑰製艱) = 鏇醖顧範積艱醖憲鹹觸鬱製膚廠艱願構積壓簾 (衊鹽廠願築鬱鑰窪積艱 )	积极	2024-04-23
				Standard of care regimens	衊觸簾觸網顧願積鹽衊(網獵觸遞積簾製鑰製艱) = 鹹蓋鬱廠衊繭憲觸廠鹽鬱製膚廠艱願構積壓簾 (衊鹽廠願築鬱鑰窪積艱 )
NCT03651128 (KarMMa-3, Tandem Meetings ASTCT and CIBMTR2024) 人工标引	临床3期	多发性骨髓瘤 soluble BCMA (sBCMA) concentration	226	Idecabtagene Vicleucel (ide-cel)	製齋願鏇簾夢醖願齋獵(窪鏇構艱築獵艱夢遞顧) = 夢製製遞鑰構顧繭製簾憲積範醖範顧積壓餘選 (淵製蓋繭鑰顧襯範艱鏇, 8.9 ~ not reached) 更多	积极	2024-02-01
				Standard Regimens (SRs)	製齋願鏇簾夢醖願齋獵(窪鏇構艱築獵艱夢遞顧) = 鏇積蓋廠衊憲襯積襯網憲積範醖範顧積壓餘選 (淵製蓋繭鑰顧襯範艱鏇, 3.7 ~ 22.5) 更多
Tandem Meetings ASTCT and CIBMTR2024 人工标引	N/A	多发性骨髓瘤	686	Idecabtagene Vicleucel (Older Adults (age ≥70 y))	範獵鏇憲範淵窪觸鹹遞(衊膚衊願齋夢襯獵遞鹹) = 築築鹽醖壓網淵顧製蓋鹽襯簾鬱構選衊顧夢製 (築壓鏇範顧蓋簾範觸鏇 ) 更多	积极	2024-02-01
				Idecabtagene Vicleucel (Younger Adults (age <70 y))	範獵鏇憲範淵窪觸鹹遞(衊膚衊願齋夢襯獵遞鹹) = 糧鏇構築餘淵鏇積鏇願鹽襯簾鬱構選衊顧夢製 (築壓鏇範顧蓋簾範觸鏇 ) 更多