Last update 26 Dec 2024
Equecabtagene Autoleucel
Last update 26 Dec 2024
Overview
Basic Info
Drug Type Autologous CAR-T |
Synonyms Anti-BMCA CAR-T cell therapy, Equ-Cel, Eque-cel + [10] |
Target |
Mechanism BCMA inhibitors(B-cell maturation protein inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CN (30 Jun 2023), |
RegulationFast Track (US), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Regenerative Medicine Advanced Therapy (US), Orphan Drug (US) |
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Gene Sequence
Sequence Code 1277314181
Source: *****
Related
12
Clinical Trials associated with Equecabtagene Autoleucel伊基奥仑赛注射液治疗复发/难治性多发性骨髓瘤患者的真实世界研究
[Translation] A real-world study of ikiorencel injection in patients with relapsed/refractory multiple myeloma
评价上市后真实世界中伊基奥仑赛注射液治疗复发/难治性多发性骨髓瘤成人患者的疗效和安全性。
[Translation]
To evaluate the efficacy and safety of ikiorencel injection in the treatment of adult patients with relapsed/refractory multiple myeloma in the real world after marketing.
Start Date15 Jul 2024 |
Sponsor / Collaborator |
A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and Refractory Multiple Myeloma.
This study is a multicenter, observational, single-arm real world study. The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in China with relapsed/refractory multiple myeloma (RRMM) who have been treated with Equecabtagene Autoleucel. This study will use both prospective and retrospective data
Start Date20 Jun 2024 |
Sponsor / Collaborator |
伊基奥仑赛注射液治疗来那度胺耐药的复发/难治性多发性骨髓瘤患者的随机对照Ⅲ期临床研究
[Translation] A randomized controlled phase III clinical study of ikiorencel injection in the treatment of patients with lenalidomide-resistant relapsed/refractory multiple myeloma
1 主要研究目的
1.1 比较伊基奥仑赛注射液与标准治疗方案在来那度胺耐药的复发/难治性多发性骨髓瘤受试者中的疗效。
2 次要研究目的
2.1 评价伊基奥仑赛注射液对比标准方案治疗来那度胺耐药的复发/难治性多发性骨髓瘤受试者的其他疗效指标；
2.2 评价伊基奥仑赛注射液对比标准方案治疗来那度胺耐药的复发/难治性多发性骨髓瘤受试者的安全性；
2.3 评价伊基奥仑赛注射液给药后的药代动力学特征；
2.4 评价伊基奥仑赛注射液给药后的药效动力学特征；
2.5 评价伊基奥仑赛注射液对比标准方案对来那度胺耐药复发/难治性多发性骨髓瘤受试者健康状态的影响。
[Translation]
1 Main study objectives
1.1 To compare the efficacy of ikiorenza injection and standard treatment regimen in subjects with lenalidomide-resistant relapsed/refractory multiple myeloma.
2 Secondary study objectives
2.1 To evaluate other efficacy indicators of ikiorenza injection compared with standard regimen in the treatment of subjects with lenalidomide-resistant relapsed/refractory multiple myeloma;
2.2 To evaluate the safety of ikiorenza injection compared with standard regimen in the treatment of subjects with lenalidomide-resistant relapsed/refractory multiple myeloma;
2.3 To evaluate the pharmacokinetic characteristics of ikiorenza injection after administration;
2.4 To evaluate the pharmacodynamic characteristics of ikiorenza injection after administration;
2.5 To evaluate the effect of ikiorenza injection compared with standard regimen on the health status of subjects with lenalidomide-resistant relapsed/refractory multiple myeloma.
Start Date04 Jun 2024 |
Sponsor / Collaborator |
100 Clinical Results associated with Equecabtagene Autoleucel
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100 Translational Medicine associated with Equecabtagene Autoleucel
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100 Patents (Medical) associated with Equecabtagene Autoleucel
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23
Literatures (Medical) associated with Equecabtagene Autoleucel01 Dec 2024·JAMA Oncology
Equecabtagene Autoleucel in Patients With Relapsed or Refractory Multiple Myeloma
Article
Author: Li, Chunrui ; Zhou, Keshu ; Chen, Lijuan ; Mi, Jian-Qing ; Chen, Bing ; Zou, Dehui ; Liu, Jing ; Ren, Hanyun ; Li, Zhenyu ; Song, Yongping ; Ding, Kaiyang ; Huang, He ; Hu, Yongxian ; Hu, Kai ; Liu, Peng ; Li, Jianyong ; Zhang, Xi ; Wang, Wen ; Cai, Songbai ; Qiu, Lugui ; Wang, Di
Importance:
Equecabtagene autoleucel (eque-cel), a fully human-derived B-cell maturation antigen-targeting chimeric antigen receptor (CAR) T-cell therapy, has exhibited potential for the treatment of relapsed or refractory multiple myeloma (RRMM), and further investigation in a larger cohort is necessary.
Objective:
To evaluate whether eque-cel can benefit patients with RRMM and determine the overall response rate postinfusion.
Design, Setting, and Participants:
The FUMANBA-1 trial was a single-arm, open-label, phase 1b/2 trial that evaluated eque-cel in adult patients with RRMM. Enrollment began in April 2020, and patients who received eque-cel will be monitored for a minimum of 15 years following the infusion. As of September 2022, patients with heavily pretreated RRMM who received at least 3 prior courses of therapy from 14 centers were enrolled. Data were analyzed from April 2020 to September 2022.
Interventions:
Patients received a single infusion of eque-cel at 1.0 × 106 CAR-positive T cells/kg after the lymphodepletion.
Main Outcomes and Measures:
Efficacy was the primary objective, and safety, pharmacokinetics, and pharmacodynamics were secondary objectives.
Results:
Of 103 patients who received an eque-cel infusion, 55 (53.4%) were male, and the median (range) age was 58 (39-70) years. A total of 101 patients were evaluable for efficacy. At a median (range) follow-up of 13.8 (0.4-27.2) months, the overall response rate was 96.0% (97 of 101), with 74.3% (75 of 103) achieving a complete response or better. Among the 12 patients who had prior CAR T-cell treatment, 75% (9 of 12) achieved a response. The median progression-free survival was not reached, with a 12-month progression-free survival rate of 78.8% (95% CI, 68.6-86.0). A total of 96 patients (95.0%) achieved minimal residual disease negativity at a sensitivity threshold of 10−5. Adverse events were favorable: 96 of 103 patients (93.2%) experienced cytokine release syndrome (grade 1 to 2 in 95 patients [92.3%]) and 2 (1.9%) experienced immune effector cell–associated neurotoxicity syndrome (grade 1 to 2). All cases of immune effector cell–associated neurotoxicity syndrome and 94 of 96 cases of cytokine release syndrome resolved with treatment. Additionally, only 20 patients (19.4%) developed antidrug antibodies. Cellular kinetic analysis confirmed CAR-positive T cells in all patients, with the longest duration at 735 days.
Conclusions and Relevance:
In this trial, eque-cel led to early, deep, and durable responses in patients with heavily pretreated RRMM with a manageable safety profile. Patients with prior CAR T-cell therapy also benefitted from eque-cel.
Trial Registration:
Chinese Clinical Trial Registry Identifier: ChiCTR2000033946
01 Nov 2024·MOLECULAR THERAPY
Long-term safety and efficacy of the fully human CAR-T therapy CT103A in relapsed/refractory multiple myeloma
Article
Author: Jiang, Lijun ; Long, Xiaolu ; Ye, Huan ; Wang, Wen ; Yu, Qiuxia ; Du, Aihua ; Hu, Guang ; Li, Zhe ; Wen, Xinyu ; Wang, Di ; Gui, Hongyu ; Zhang, Peiling ; Bao, Yuhan ; An, Ning ; Wang, Jue ; Mu, Wei ; Cai, Songbai ; Li, Chunrui ; Li, Chunhui ; Shu, Chang
CT103A is a fully human chimeric antigen receptor T cell (CAR-T) product for targeting B cell maturation antigen. This study presents the updated safety and efficacy profiles of CT103A in patients with relapsed/refractory multiple myeloma (RRMM) after long-term follow-up. As of July 31, 2023, the median follow-up time after CAR-T cell infusion was 45.0 months (range, 0.7-58.3 months). During long-term follow-up, the incidence of adverse events gradually decreased over time. One patient had a maximum duration of response of nearly 5 years. All 18 patients (100%) achieved partial remission or better; 77.8% (14 of 18) of patients eventually exhibited complete response or stringent complete response (sCR), with response increasing over time. At the time of data cutoff, nine patients were still alive and seven patients had an sCR status with negative minimal residual disease. The median progression-free survival was 22.6 months, and the median overall survival was 50.2 months for all 18 patients. The median CAR transgene persistence was 14.0 months (range, 0.7-57.3 months). Long-term follow-up demonstrated that CT103A confers durable clinical benefit for RRMM patients based on the sustained presence of fully human CAR-T cells.
01 Sep 2024·JOURNAL OF BIOMATERIALS APPLICATIONS
Novel poly(lactic-co-glycolic acid) nanoliposome-encapsulated diclofenac sodium and celecoxib enable long-lasting synergistic treatment of osteoarthritis
Article
Author: Lv, Wei ; Chen, Dagui ; Ma, Senlin ; Chu, Bo ; Li, Yinghua ; Shang, Fusheng ; Yang, Yong
Background: Diclofenac sodium (DS) and celecoxib (CEL) are primary anti-inflammatory agents used in the treatment of osteoarthritis (OA). Formulating these drugs into extended-release versions can effectively address the issue of multiple daily doses. In this study, we designed and synthesized a novel poly(lactic-co-glycolic acid) (PLGA) nanoliposome as a dual-drug delivery sustained-release formulation (PPLs-DS-CEL) to achieve long-lasting synergistic treatment of OA with both DS and CEL. Methods: PPLs-DS-CEL was synthesized by the reverse evaporation method and evaluated for its physicochemical properties, encapsulation efficiency, drug release kinetics and biological properties. A rat OA model was established to assess the therapeutic efficacy and biosafety of PPLs-DS-CEL. Results: The particle size of PPLs-DS-CEL was 218.36 ± 6.27 nm, with a potential of 32.56 ± 3.28 mv, indicating a homogeneous vesicle size. The encapsulation of DS and CEL by PPLs-DS-CEL was 95.18 ± 4.43% and 93.63 ± 5.11%, with drug loading of 9.56 ± 0.32% and 9.68 ± 0.34%, respectively. PPLs-DS-CEL exhibited low cytotoxicity and hemolysis, and was able to achieve long-lasting synergistic analgesic and anti-inflammatory therapeutic effects in OA through slow release of DS and CEL, demonstrating good biosafety properties. Conclusion: This study developed a novel sustained-release nanoliposomes formulation capable of co-loading two drugs for the long-acting synergistic treatment of OA. It offers a new and effective therapeutic strategy for OA treatment in the clinic settings and presents a promising approach for drug delivery systems.
67
News (Medical) associated with Equecabtagene Autoleucel15 Dec 2024
SAN FRANCISCO and SUZHOU, China, Dec. 15, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, and Eli Lilly and Company (NYSE: LLY) today jointly announced a Distribution and Promotion Agreement in Mainland China regarding Lilly's non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets). The agreement highlights the following aspects:
Innovent will be responsible for the importation, marketing, distribution and promotion of Jaypirca®;
Lilly will be responsible for the R&D and post-market medical affairs of Jaypirca®.
Jaypirca®, a highly selective kinase inhibitor, utilizes a novel non-covalent binding mechanism to re-establish BTK inhibition in mantle cell lymphoma (MCL) patients previously treated with a covalent BTK inhibitor (approved including ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) and extend the benefit of targeting the BTK pathway, thus effectively addressing the unmet clinical needs for these patients. Approved by the U.S. FDA in January 2023, Jaypirca® (pirtobrutinib) became the first and only approved non-covalent (reversible) BTK inhibitor. In October 2024, Jaypirca® (pirtobrutinib) received approval from China's National Medical Products Administration (NMPA) as monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two types of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor (Link).
Lilly is conducting comprehensive global Phase 3 development programs (including in China), in first-line and relapse or refractory patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and BTK inhibitor-naïve relapse or refractory MCL, to explore monotherapy or combination therapy.
Under the agreement, Innovent holds the sole commercialization rights for Jaypirca® in Mainland China, overseeing importation, marketing, distribution and promotion. Lilly will be responsible for R&D and post-market medical affairs. Leveraging Innovent's established hematology oncology commercial team and Lilly's deep expertise in drug development and scientific insights in the therapeutic area, the partnership is committed to broadening access to innovative treatments and improving outcomes for cancer patients in Mainland China.
Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "Building on our long-term strategic collaboration with Lilly, we are proud to expand our collaboration through this agreement. Jaypirca®, the world's first and only approved non-covalent (reversible) BTK inhibitor, represents a breakthrough treatment option for patients who have previously received BTK inhibitors. Innovent has built a robust and leading portfolio in the hematological malignancy field, consisting of TYVYT® (sintilimab injection), HALPRYZA® (rituximab injection), olverembatinib, FUCASO® (Equecabtagene Autoleucel Injection), and Jaypirca®. By fully leveraging our commercialization capabilities and extensive coverage in this field, we aim to bring forward innovative medicines to benefit cancer patients and further enhance our leading position in oncology. We remain steadfast in our commitment to advancing the biopharmaceutical industry through collaborative efforts so that first-rate pharmaceutical drugs can become widely accessible."
Huzur Devletsah, President and General Manager of Lilly China, states, "Lilly is thrilled to appoint Innovent for the distribution and promotion of Jaypirca® marking a pivotal moment in hematologic cancer treatment for Lilly. This agreement allows to rapidly increase patient access in Mainland China by drawing on Innovent's robust market presence and our extensive R&D expertise. Together, we are poised to deliver innovative therapies and support the 'Healthy China 2030' initiative, continuing our commitment: 'In China, For China."
About Jaypirca® (pirtobrutinib)
Jaypirca® (pirtobrutinib, formerly known as LOXO-305) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.[i] BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma.[ii],[iii]
About Innovent's strategic cooperation with Lilly
Innovent and Lilly have established a comprehensive level of cooperation, setting an example of partnership between a Chinese innovative pharmaceutical company and a global leading medicine company in the field of R&D, CMC, clinical development and commercialization, aiming to accelerate the access of innovative medicines to benefit more patients worldwide.
In March 2015, Innovent entered into a strategic partnership with Lilly focused on biological medicine. Under the initial agreement, Lilly and Innovent co-developed and co-commercialized oncology medicines, including Tyvyt® (sintilimab injection) in China. In October 2015, the two parties announced the extension of collaboration to include the co-development of three additional antibodies in oncology. In August 2019, the cooperation extended with a licensing agreement for the development and commercialization of a potentially global best-in-class investigational GCG/GLP-1 medicine in China. In August 2020, Innovent and Lilly announced a global expansion of their strategic alliance for sintilimab. In March 2022, Lilly and Innovent deepened their engagement in oncology, granting Innovent sole commercialization rights for Cyramza® (ramucirumab) and Retsevmo® (selpercatinib), and a right of first negotiation for potential future commercialization of Jaypirca® (pirtobrutinib) in Mainland China. In December 2024, the agreement of the commercialization of Jaypirca® (pirtobrutinib) in Mainland China officially achieved.
About Innovent Biologics
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 12 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn.
Statement:
（1）Innovent does not recommend the use of any unapproved drug (s)/indication (s).
（2）Ramucirumab (Cyramza), Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company.
About Eli Lilly and Company
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit .
Forward-Looking Statements of Innovent Biologics
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.
The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.
References
SOURCE Innovent Biologics
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License out/inDrug ApprovalPhase 3Biosimilar
10 Dec 2024
SHANGHAI and NANJING, China and SAN JOSE, Calif., Dec. 9, 2024 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today shared findings via a poster presentation of the results on
the impact of CAR T-Cell Persistence on Clinical Outcomes in Relapsed/Refractory Multiple Myeloma(R/RMM) with Equecabtagene Autoleucel (Eque-cel, FUCASO) at the 66th American Society of Hematology (ASH) Annual Meeting. The results highlighted
the importance of the efficacy-to-target ratio in the treatment of multiple myeloma, emphasizing the crucial role of sustained CAR T-cell persistence, unaffected by baseline soluble B-cell maturation antigen (sBCMA) levels, to achieve optimal disease control.
Continue Reading
Table 1：Influencing factors analysis for CAR-T cell persistence
Title: Impact of CAR T-Cell Persistence on Clinical Outcomes in Relapsed/Refractory Multiple Myeloma: Insights from the Phase 2 FUMANMA-1 Study
Publication Number: 4761
Presentation Time: 6:00 PM -8:00 PM, Monday, December 9, 2024（San Diego）
Conclusions
The efficacy-to-target ratio is a crucial determinant of clinical outcomes in patients treated with Eque-cel, underscoring the importance of CAR T-cell persistence.
This ratio may serve as a biomarker for future treatment planning, highlighting the need for sustained CAR T-cell persistence to achieve optimal disease control.
Baseline sBCMA levels do not negatively affect the persistence and efficacy of Eque-cel.
This post-hoc analysis of the Phase 2 study of FUMANBA-1 primarily investigated the relationship between CAR T-cell persistence and progression-free survival (PFS) as well as time to progression (TTP). It also examined the impact of sBCMA levels through the lens of the efficacy-to-target ratio, measured by the ratio of vector copy number (VCN) duration to baseline sBCMA levels. With a median follow-up of 24.67 months, 107 patients in 14 centers were treated with Eque-cel.
At the data cutoff, the ongoing remission group showed a longer median VCN duration than those with progression or relapse（12.52m vs 9.03m）,as shown in Figure 1.The median efficacy-to- target ratio for the 107 subjects was 1.05 (days*mL/ng). As shown in Figure 2, those with a lower ratio had a significantly higher risk of disease progression, with a hazard ratio (HR) for TTP of 3.07 (95% CI: 1.51–6.24, p=0.0011) and for PFS of 2.3 (95% CI: 1.27–4.14, p=0.0045), both indicating a strong correlation between the efficacy-to-target ratio and the risk of disease progression.
Among baseline characteristics—including ECOG score, R-ISS and ISS disease stages, tumor BCMA expression, tumor burden, baseline sBCMA level, previous autologous stem cell transplantation (ASCT), triple-class exposure, bridging therapy, prior CAR-T treatment, and lymphodepleting conditioning—only previous ASCT (n=30) and ADA as post-infusion factors were significantly associated with Eque-cel persistence, with hazard ratios (HR) 0.35 and 5.79, respectively, as shown in Table 1.
Among the 107 subjects, only 14 exhibited an aplastic neutrophil recovery phenotype, characterized by persistent neutrophil counts below 500/μl for 14days or more. This phenotype did not significantly affect VCN duration compared to patients without the condition, indicating that the long-term persistence of Eque-cel does not increase hematological toxicity.
The principal investigator of this study,
Professor Lugui Qiu, from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, and Professor Chunrui Li, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated:
"This post-hoc analysis explored the determinants of long-term efficacy after CAR-T treatment through the lens of the efficacy-to-target ratio (VCN persistence/sBCMA). It confirmed the significance of this ratio in achieving long-term control of multiple myeloma (PFS and TTP). The findings suggest that a CAR-T product with long-lasting efficacy, unaffected by the target, which means not affected by sBCMA levels, would be a more optimal choice in the treatment of MM.
The result further highlighted the crucial role of sustained persistence of CAR-T cells in improving the prognosis of patients with R/RMM. In our 2023 ASH oral report, we previously confirmed a positive correlation between Eque-cel persistence and the maintenance of MRD negativity. The median duration time of CAR-T cells for Eque-cel was 419 days, which may be a key factor in achieving the high MRD negativity rate of 97.8% and the sustained MRD negativity rate of 81.7% at 12 months post-infusion.
Notably, only 14 of 107 subjects exhibited aplastic neutrophil recovery lasting 14 days or more. This finding indicates that the long-term persistence of Eque-cel does not increase hematological toxicity, further validating the safety of this therapy."
Dr. Jie Chen, Chief Medical Officer of IASO Bio, stated:
The outcomes presented by IASO Bio at the ASH Annual Meeting highlighted the significant impact of the efficacy-to-target ratio on disease control in multiple myeloma. The data demonstrated that subjects with an efficacy-to-target ratio above the median value had a better prognosis in terms of PFS and TTP. These findings further confirmed the positive effect of long-term CAR-T cells persistence in achieving sustained remission. Eque-cel was deliberately selected in its early development to be a candidate molecule not influenced by sBCMA levels, offering patients deeper and more durable remission. Additionally, the study showed that only a small number of patients experienced neutropenia lasting more than 14 days after treatment with Eque-cel. The result affirmed that the long-term persistence of Eque-cel does not increase the hematological toxicity, further validating its safety profile.
We are fully confident in the outstanding efficacy and safety of Eque-cel. Currently, We have initiated and are rapidly advancing a randomized controlled Phase 3 clinical study of this therapy for second- and third-line multiple myeloma. We look forward to bringing this advanced therapy to a broader population of multiple myeloma patients both domestically and internationally as soon as possible."
About FUMANBA-1 Study
FUMANBA-1 is a single-arm, open-label phase 1b/2 registrational clinical study conducted in 14 Chinese centers to assess the efficacy and safety of the Equecabtagene Autoleucel in patients with R/RMM who have received ≥3 lines of prior therapies. The trial enrolled patients with RRMM who had previously received at least three lines of therapy, including proteasome inhibitors and immunomodulatory agents-based chemotherapy regimens, and had disease progression on their last line of therapy. Patients who had previously received BCMA CAR-T therapy were also eligible for enrollment.
About IASO Bio
IASO Bio is a biopharmaceutical company focused on the discovery and development of innovative cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercialization.
Its pipeline includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received Biologics License Application (BLA) approval from China's National Medical Products Administration (NMPA) in June 2023 and U.S. FDA IND approval for the treatment of R/RMM in December 2022.
Leveraging its strong management team, innovative product pipeline, as well as integrated and high quality manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China and around the world. For more information, please visit or .
SOURCE IASO Bio
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Clinical ResultPhase 2Cell TherapyImmunotherapyPhase 3
08 Nov 2024
—— The Phase 1b/2 study FUMANBA-1 demonstrates Equecabtagene Autoleucel led to deep and durable responses in patients with R/RMM
—— The data shows the overall response rate（ORR）was 96.1%，the ORR reached 98.9% among the patients without prior CAR-T therapy
——Among the 103 patients, only one experienced ≥ Grade 3 cytokine release syndrome (CRS), with no ≥ Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS)
SHANGHAI and NANJING, China and SAN JOSE, Calif., Nov. 7, 2024 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, today announced that the results of the phase 1b/2 clinical study FUMANBA-1 of its fully human anti-BCMA CAR-T therapy, Equecabtagene Autoleucel (trade name: Fucaso™), for the treatment of relapsed/refractory multiple myeloma (R/RMM), have been published in the leading medical journal JAMA Oncology. The study evaluated the efficacy and safety of Equecabtagene Autoleucel in patients with R/RMM who had previously received ≥3 lines of prior therapies. The results demonstrated that Equecabtagene Autoleucel achieved a high overall response rate and durable remission in patients, with a favorable safety profile.
JAMA Oncology published clinical data on 103 patients who received infusion of Equecabtagene Autoleucel (Fucaso™) as of September 9, 2022, with a median follow-up of 13.8 months (range: 0.4-27.2 months). In terms of efficacy, among the 101 evaluable patients, the overall response rate (ORR) was 96.0% (97/101), and the stringent complete response/complete response rate (sCR/CR) was 74.3% (75/101). Among the 89 patients without prior CAR-T therapy, the ORR was 98.9% (88/89), and the sCR/CR rate was 78.7% (70/89). In these 101 patients, the median time to response was 16 days (range: 11-179), while the median duration of response (DOR) and median progression-free survival (PFS) had not been reached yet. The 12-month PFS rate was 78.8% (95% CI: 68.6-86.0). Additionally, 95% (96/101) of the patients achieved minimal residual disease (MRD) negativity, with a median time to MRD negativity of 15 days (range: 14-186). All patients with sCR/CR achieved MRD negativity, and the median duration of MRD negativity had not been reached.
In terms of safety, 93.2% (96/103) of the patients experienced cytokine release syndrome (CRS), most of which were grade 1 or 2, with only one patient experiencing grade 3 or higher CRS. Only 1.9% (2/103) of the patients developed immune effector cell-associated neurotoxicity syndrome (ICANS), with one case each of grade 1 and grade 2.
Notably, updated data from this study, as of December 31, 2022, was presented during the 2023 American Society of Hematology (ASH) Annual Meeting. The median follow-up had increased to 18.07 months, with an ORR of 96.1% among the 103 evaluable patients. The sCR/CR rate was 77.7%, and all patients who achieved CR or better exhibited 100% MRD negativity. Among the 91 patients without prior CAR-T therapy, the ORR reached 98.9%, with an sCR/CR rate of 82.4% and an MRD negativity rate of 97.8%. Notably, 81.7% of these patients remained MRD-negative at 12 months post-infusion, with a 12-month PFS rate was 85.5%. In addition, Equecabtagene Autoleucel could showed prolonged persistence in the body, at 12 months post-infusion, 50% of patients had a vector copy number (VCN) above the limit of detection, and 40% still had detectable VCN persistence at 24 months.
Professor Lu-gui Qiu, from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, stated: "The results of the FUMANBA-1 study demonstrate the encouraging efficacy and safety of Equecabtagene Autoleucel in treating patients with relapsed/refractory multiple myeloma. Its groundbreaking fully human scFv design overcomes the high immunogenicity issues commonly associated with animal-derived CAR-T cells while maintaining optimal affinity for BCMA-expressing tumor cells. Its excellent dissociation kinetics facilitates rapid expansion and long-term persistence of Equecabtagene Autoleucel in vivo."
Professor Huang He, from The First Affiliated Hospital, Zhejiang University School of Medicine, stated, "Equecabtagene Autoleucel (Fucaso™) was approved in China in June 2023. Over the past year since its launch, it has brought significant survival benefits to patients with relapsed/refractory multiple myeloma in China and from overseas. Meanwhile, we have accumulated valuable real-world experience, and we expect this innovative therapy to benefit more patients."
Professor Chunrui Li, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated: "Equecabtagene Autoleucel is the world's first fully human CAR-T therapy to be approved. It's binding to BCMA, utilizing both heavy and light chains with optimal affinity, facilitates dissociation from BCMA antigen after tumor cell killing, thereby reducing CAR-T cell self-exhaustion. Along with lower immunogenicity, this leads to rapid, deep, and sustained remission in patients with multiple myeloma."
Dr. Jie Chen, Chief Medical Officer of IASO Bio, stated: "We are delighted that the phase 1b/2 clinical study data of Equecabtagene Autoleucel for the treatment of R/RMM has been published in JAMA Oncology. The results of this study, which targeted patients with R/RMM who had previously received ≥3 lines of prior therapies are very inspiring. We thank the FUMANBA-1 research team for their rigorous scientific approach and high-standard execution. Currently, IASO Bio is actively conducting and advancing the phase III clinical study (FUMANBA-3) of Equecabtagene Autoleucel for the treatment of multiple myeloma patients who have received 1-2 lines of prior therapies. We anticipate this clinical study, based on clinical data from Chinese patients, will yield positive results soon, bringing new treatment option for more patients."
About FUMANBA-1 study
FUMANBA-1 is a single-arm, open-label phase 1b/2 registrational clinical study conducted in 14 Chinese centers to assess the efficacy and safety of the Equecabtagene Autoleucel in patients with R/RMM who have received ≥3 lines of prior therapies. The trial enrolled patients with RRMM who had previously received at least three lines of therapy, including proteasome inhibitors and immunomodulatory agents-based chemotherapy regimens, and had disease progression on their last line of therapy. Patients who had previously received BCMA CAR-T therapy were also eligible for enrollment.
About Equecabtagene Autoleucel (Fucaso™)
Equecabtagene Autoleucel (Fucaso™) is an innovative fully-human anti- BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, Fucaso™ demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper remissions, providing continuous protection and care for those suffering from multiple myeloma.
About IASO Bio
IASO Bio is a biopharmaceutical company focused on the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercialization.
Its pipeline includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received Biologics License Application (BLA) approval from China's National Medical Products Administration (NMPA) in June 2023and U.S. FDA IND approval for the treatment of R/RMM in December 2022.
Leveraging its strong management team, innovative product pipeline, as well as integrated and high quality manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China and around the world. For more information, please visit or .
SOURCE IASO Bio
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Clinical ResultImmunotherapyDrug ApprovalPhase 3Cell Therapy
100 Deals associated with Equecabtagene Autoleucel
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R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Multiple Myeloma | CN | 30 Jun 2023 | |
| Multiple Myeloma | CN | 30 Jun 2023 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Relapse multiple myeloma | Phase 3 | CN | 27 Mar 2024 | |
| Refractory Multiple Myeloma | Phase 1 | US | 08 May 2023 | |
| Hashimoto's Encephalitis | Phase 1 | CN | 22 Sep 2020 | |
| Idiopathic Inflammatory Myopathies | Phase 1 | CN | 22 Sep 2020 | |
| Multiple Sclerosis | Phase 1 | CN | 22 Sep 2020 | |
| Myasthenia Gravis | Phase 1 | CN | 22 Sep 2020 | |
| Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 1 | CN | 22 Sep 2020 | |
| Neuromyelitis Optica | Phase 1 | CN | 22 Sep 2020 | |
| POEMS Syndrome | Phase 1 | CN | 22 Sep 2020 | |
| Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Phase 1 | CN | 22 Sep 2020 |
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Clinical Result
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 2 | 107 | (high efficacy-to-target ratio group) | sihnywczwj(xqyiwkdoas): HR = 2.3 (95% CI, 1.27 - 4.14), P-Value = 0.0045 View more | Positive | 09 Dec 2024 | ||
(a low ratio group) | |||||||
Phase 1/2 | 91 | 伊基奥仑赛 (淋巴细胞清除剂量发生了调整) | rtyzbpkodg(wrhanqsgle) = qlctkuhmcc bzhpjinsey (fbpasvnknf ) View more | Positive | 29 Sep 2024 | ||
伊基奥仑赛 (标准的清淋剂量) | rtyzbpkodg(wrhanqsgle) = eiekmkhcyq bzhpjinsey (fbpasvnknf ) View more | ||||||
Phase 2 | 91 | (肾损组) | euhcpgdaqa(zqavexvvjl) = 在疗效方面，肾损组的大多数基线特征与非肾损组相当。肾损组也能实现与非肾损组一样快速和深入的缓解。肾损组的长期疗效与非肾损组相当。 mylxkgivdb (jbwqcbrnwn ) View more | Positive | 27 Sep 2024 | ||
(非肾损组) | |||||||
NCT04561557 (PRNewswire) Manual  | Early Phase 1 | 12 | 伊基奥仑赛注射液 | mzthdqegzu(qlfdznifhp) = 良好耐受性和安全性 cuvibwohul (rkwxortwls ) View more | Positive | 01 Jul 2024 | |
Phase 1 | Multiple Myeloma First line | 16 | vqkusmrkyl(hutgubsghu) = xvghqdkjfz uldapuuudv (ykagfkflfm ) View more | Positive | 14 May 2024 | ||
NCT04561557 (Pubmed) Manual | Early Phase 1 | 2 | ilxjunnugg(bnlvooybyr) = izfbyhwhse nkxkzttiug (qtprqtdnza ) | Positive | 26 Feb 2024 | ||
Early Phase 1 | 1 | ykjmifxrdy(pbkhisdxfj) = The patient developed only grade 1 cytokine release syndrome (CRS), but had no immune effector cell-associated neurotoxicity syndrome (ICANS). Only transient hemocytopenia was observed. frkcifjrbv (mmyxnukocq ) View more | Positive | 30 Jan 2024 | |||
Phase 1 | 18 | fogzbbwbjo(erhspfixxn) = The recovery of B cells and globulin were observed in 5 and 15 patients, respectively. But for the seven alive patients with sCR, only two of them had B cell recovered. eistmgsjbh (qjpjwiqwcb ) View more | Positive | 11 Dec 2023 | |||
Phase 1/2 | 105 | Eque-cel | cpctaxemhs(wwpoomdckk) = tzebnhiqzi vawmediftu (mtiwuovcwm, 80.07 - 96.92) View more | Positive | 26 Sep 2023 | ||
Phase 1/2 | Relapse multiple myeloma Last line | 103 | jnksvzqhqb(qwukxzjkdn) = xztnsbyajj jjhjwtmqmp (dbtlkwgmwg ) View more | Positive | 26 May 2023 |
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