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Tags Archives: ASH2023

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6 months ago CAR-T

Breakthrough Advances in CAR-T Cell Therapy Combined with TKI for Malignant Hematologic System Tumors

Breakthrough Advances in CAR-T Cell Therapy Combined with TKI for Malignant Hematologic System Tumors
At this year’s ASH conference, Professor Huang He, the director of the First Affiliated Hospital of Zhejiang University School of Medicine, presented a significant study on CAR-T cell therapy for B-ALL, marking a groundbreaking stride in the treatment of malignant hematologic system tumors.
 
This study, targeting newly diagnosed adult Ph-positive acute lymphoblastic leukemia, investigated the combined treatment of dasatinib and CAR-T cell therapy as a frontline therapy for initial patients. The integration of CAR-T cell therapy with tyrosine kinase inhibitors (TKI) aimed to enhance treatment effectiveness.
 
The study revealed promising outcomes: among 18 patients, the complete molecular remission rate after CD19 CAR-T cell therapy reached 72.2%. Among these patients, subsequent treatment with CD22 CAR-T cells achieved a complete molecular remission rate of 76.9%. At a median follow-up of 13.5 months post CAR-T cell therapy, 16 patients maintained complete hematological remission, while 14 patients sustained complete molecular remission without undergoing allogeneic transplantation. Notably, no CRS (cytokine release syndrome) ≥ Grade 3 or ICANS (immune effector cell-associated neurotoxicity syndrome) occurred during CAR-T cell therapy.
Professor Huang He’s team’s groundbreaking research presented at the ASH conference signifies a leap forward in the treatment of blood-related cancers, signaling a more efficient and accessible era. These findings instill hope for refining treatment strategies and potentially making a significant impact in the field of hematologic oncology.
Beyond the groundbreaking progress in CAR-T cell therapy combined with TKI, the team showcased seven oral presentations and 26 poster exhibitions. These studies encompassed fundamental research on blood disorders, leukemia pathogenesis, acute lymphoblastic leukemia, acute myeloid leukemia, lymphoma, myeloma, hematopoietic stem cell transplantation, and cellular immunotherapy, all crucial for enhancing clinical practices.
 
We eagerly anticipate further groundbreaking strides by Chinese research teams in cancer treatment studies, anticipating the transformative impact of these research findings in the future.
 
 
#ASHAnnualMeeting #HematologyResearch #CARTCellTherapy #StemCellTransplantation #BloodCancer #ClinicalInnovation #OncologyAdvancements #Cancertherapy #MedicalResearch #ASH #CART #CARTTherapy #CARTCell #TKI #tyrosinekinaseinhibitors

7 months ago CAR-T

The latest research findings of BCMA CAR-T therapy for multiple myeloma in 2023 | Equecabtagene Autoleucel (FUCASO)

The latest research findings of BCMA CAR-T therapy for multiple myeloma in 2023 | Equecabtagene Autoleucel (FUCASO®)
    IASO Bio and Innovent presented their latest research findings on the Equecabtagene Autoleucel injection (brand name: FUCASO®) for multiple myeloma at the 2023 American Society of Hematology (ASH) Annual Meeting. This study was primarily based on a post-hoc analysis of the FUMANBA-1 study, an Ib/II phase research assessing the efficacy and safety of this therapy in treating patients with relapsed and refractory multiple myeloma (RRMM).
    As of December 31, 2022, with a median follow-up of 18.07 months, deep and sustained responses were observed in 103 evaluable patients. Among these patients, the overall response rate (ORR) was 96.1%, and the stringent complete response/complete response (sCR/CR) rate was 77.7%. Among subjects without prior CAR-T therapy, the ORR reached 98.9%, the sCR/CR rate reached 82.4%, and the 12-month progression-free survival (PFS) rate was 85.5%.
Minimal residual disease (MRD) negativity rate is 94.2% in the total evaluable patients, and all patients who achieved CR or above were MRD negative. The median time to achieve MRD negativity was 15 days, with 80.8% of patients remaining MRD negative at 12 months post infusion.
In addition, Equecabtagene Autoleucel could persist in the body for an extended period of time the median duration was 307.5 days. 12 months after infusion, 50% of patients had a vector copy number (VCN) above the lower limit of detection; and 24 months after infusion, VCN could still be detected in 40% of the patients.
The research findings indicate a strong correlation between sustained MRD negativity and patient progression-free survival (PFS), along with the continuous presence of Equecabtagene Autoleucel in the body, which correlates positively with sustained MRD negativity.
The Equecabtagene Autoleucel injection may improve the long-term survival prospects of RRMM patients, offering enduring deep remission and holding significant importance for the sustained maintenance of MRD negativity in patients.
About Multiple Myeloma (MM)
Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there’s currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma. In the United States, MM accounts for nearly 2% of all cancer cases, and more than 2% of cancer-related deaths.
According to Frost & Sullivan, the number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020 and is expected to increase to 37,800 by 2025. Additionally, the total number of patients diagnosed with MM increased from 132,200 in 2016 to 144,900 in 2020 and is expected to rise to 162,300 by 2025. In China, the number of new MM cases rose from 18,900 in 2016 to 21,100 in 2020 and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020 and is expected to rise to 182,200 by 2025.
About Equecabtagene Autoleucel
Equecabtagene Autoleucel is an innovative fully-human anti-BCMA CAR-T cell therapy that uses lentivirus as a gene vector to transfect autologous T cells. The CAR comprises a fully-human scFv, CD8a hinge and transmembrane, as well as 4-1BB-mediated co-stimulation and CD3ζ activation domains. Through rigorous screening and comprehensive in vivo and in vitro evaluation, Equecabtagene Autoleucel has been proven to possess potent and rapid anti-myeloma activity, along with outstanding safety, efficacy, and persistence results.
Equecabtagene Autoleucel has received acceptance for New Drug Application (NDA) from China’s National Medical Products Administration (NMPA) for the treatment of RRMM and has obtained IND approval from the U.S. FDA. Additionally, the company was granted Breakthrough Therapy Designation (BTD) by the NMPA in February 2021, Orphan Drug Designation (ODD) in February 2022, and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations from the FDA in February 2023. Besides multiple myeloma, NMPA has accepted its IND application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). Innovent and IASO Bio are collaboratively developing Equecabtagene Autoleucel for the treatment of RRMM in mainland China.
About IASO Biotechnology
IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput chimeric antigen receptor T-cell (CAR-T) drug screening platform, and proprietary manufacturing processes, IASO Bio is developing a robust clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. This pipeline comprises a diversified portfolio of over 10 novel products, including IASO’s flagship asset, Equecabtagene Autoleucel (CT103A), a fully human BCMA CAR-T injection.
In addition to Equecabtagene Autoleucel, the company’s pipeline includes the fully developed in-house human CD19/CD22 dual-targeted CAR-T cell therapy, which has received two IND clearances for treating relapsed/refractory B-cell non-Hodgkin’s lymphoma (r/r B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (r/r B-ALL). CD19/CD22 is currently in Phase I clinical trials for r/r B-NHL. It was also granted ODD by the FDA in October 2021. In the approximately 20 patients dosed to date in the investigator-initiated trial, there were no immune effector cell-associated neurotoxicity syndrome (ICANS) observed in any patient, and the rate of grade 3 cytokine release syndrome (CRS) was less than 5%, with the remainder of patients experiencing no CRS or less than grade 3.
Leveraging its strong management team, innovative product pipeline, integrated manufacturing, and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfill unmet medical needs to patients in China and around the world.

7 months ago CAR-T

Breakthrough medical research in China brings hope for multiple myeloma patients.

Eque-cel brings new treatment prospects for multiple myeloma.

    From December 9th to 12th, the Annual American Society of Hematology Meeting (ASH 2023) was held in San Diego, USA. At this conference, the FUMANBA-1 study, led by Professors Chunrui Li from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Lugui Qiu from the Institute of Hematology, Chinese Academy of Medical Sciences, conducted at 14 medical centers nationwide, demonstrated the efficacy and characteristics of sustained minimal residual disease (MRD) negativity in multiple myeloma (MM) patients treated with Eque-cel injection (CT103A). Their achievements were included in the oral presentation at the conference.

Current MM Treatment and Challenges of CAR-T Therapy CAR-T cell therapy holds significant importance in the treatment of multiple myeloma, overcoming patients’ immunodeficiency and tolerance issues. Currently, China has approved three CAR-T cell drugs targeting multiple myeloma. Compared to traditional treatments, CAR-T cell therapy enhances immune function without relying on the major histocompatibility complex (MHC), improving the activity of NK cells, T cells, and B cells while effectively activating T cells. However, despite significant advancements in CAR-T cell therapy in the MM field, some patients still struggle to maintain treatment effectiveness, leading to potential relapses, with antigen escape being one of the important mechanisms causing relapse.

Furthermore, the safety of CAR-T therapy is a major concern, including adverse reactions such as cytokine release syndrome (CRS), neurotoxicity, infections, B cell depletion, and hypogammaglobulinemia. Hence, monitoring patient indicators throughout the entire CAR-T treatment process, from pre-treatment to infusion, is crucial for timely intervention in adverse reactions.

    100% MRD Negativity Rate for CR and Above Patients! Eque-cel Injection Brings Redemption for Multiple Myeloma

    Eque-cel injection (CT103A) is a fully humanized CAR-T cell therapy drug targeting B cell maturation antigen (BCMA), approved by the National Medical Products Administration (NMPA) for adult refractory/relapsed multiple myeloma patients in China. In the Phase II FUMANBA-1 study, this treatment showed significant and sustained efficacy.

As of December 31, 2022, with a median follow-up time of 18.07 months, deep and sustained remissions were observed in 103 evaluable patients. The overall response rate (ORR) among these 103 patients was 96.1%, with a strict complete response (sCR)/complete response (CR) rate of 77.7%. Among 91 subjects with no previous CAR-T treatment history, the ORR was 98.9%, and the sCR/CR rate reached 82.4%, with a 12-month progression-free survival (PFS) rate of 85.5%.

The minimal residual disease (MRD) negativity rate for the entire population was 94.2%, reaching 100% for CR and above patients. The median time to MRD negativity was 15 days, and 80.8% of patients maintained MRD negativity 12 months post-infusion. Moreover, the Eque-cel injection exhibited a relatively long median persistence in the body, lasting up to 307.5 days.

According to Professor Chunrui Li, “The sustained MRD-negative status is closely related to the improvement in PFS of patients receiving Eque-cel treatment.”

Professor Chunrui Li’s team studied the characteristics of patients maintaining MRD negativity for ≥6 months and ≥12 months in the FUMANBA-1 study. The research revealed that among 88 patients achieving MRD negativity, 78.4% maintained MRD negativity for at least 6 months, and 74.4% sustained MRD negativity for at least 12 months. Patients with sustained MRD negativity showed longer…

Professor Chunrui Li:

Chief Physician, Doctoral Supervisor

Secretary of the Hematology Department Party Committee,  Deputy Director of Medicine Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Professional

Focus: Immunotherapy for Hematological Malignancies

Member of the 11th Committee of the Plasma Cell Disease Professional Group of the Hematology Branch of the Chinese Medical Association

Chairman of the Expert Committee on Hematology (Hubei), Geriatrics Branch, Chinese Geriatrics and Gerontology Society

Standing Committee Member of the Geriatric Medicine Branch, Chinese Geriatrics and Gerontology Society

Youth Committee Member of the Oncology Branch, Chinese Anti-Cancer Association Committee Member of the Myeloma and Plasma Cell Disease Professional Group, 5th Committee of the Chinese Society of Clinical Oncology (CSCO) Leukemia Alliance & Lymphoma Alliance

Vice Chairman of the Blood Branch of the Hubei Medical Immunology Association Principal Investigator of four National Natural Science Foundation projects; published more than 20 SCI papers as first author or corresponding author, including Blood.

 

#EqueCelTreatment #MMResearch #CARTTherapy #MRDNegativity #CancerTreatment #MedicalBreakthrough #FUMANBA1Study #Immunotherapy #CancerResearchUpdate #CancerResearch #ASH2023 #BloodCancer #EqueCel #MRD #MultipleMyeloma

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