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12 months ago CAR-T

Clinical Breakthrough: Chinese CAR-T – Inaticabtagene Autoleucel Revolutionizing Hematologic Cancer Therapy

“Clinical Breakthrough: Chinese CAR-T – Inaticabtagene Autoleucel Revolutionizing Hematologic Cancer Therapy”
On January 5, 2024, the Fourth Chinese Hematology Development Conference was convened in Tianjin, China, concurrently hosting the CAR-T Frontier Forum and the First CAR-T Cell Immunotherapy Summit (JCIS). The focus was directed towards the latest advancements and clinical applications of Inaticabtagene Autoleucel, presenting new pathways for standardized treatments.
 
Under the moderation of Professors Wu Depei and Hu Yu, Professor Wang Ying from the Institute of Hematology at the Chinese Academy of Medical Sciences presented a specialized lecture titled “Interpreting Key Clinical Data of Inaticabtagene Autoleucel.” Professor Wang highlighted the challenges faced by adult B-ALL patients in China, commonly treated with salvage chemotherapy ± hematopoietic stem cell transplantation. However, the median survival period is only 2-6 months, and targeted therapies yield a median survival of merely 7.7 months, necessitating an urgent need for more effective treatment methods. Recently, the Inaticabtagene Autoleucel infusion has been approved for treating adult R/R B-ALL patients.
 
Critical clinical research (NCT04684147) has revealed the substantial outcomes achieved with a single treatment of Inaticabtagene Autoleucel:
 
Rapid and profound remission: Within 3 months of treatment, the overall response rate (ORR) reached an impressive 82.1%, with a 100% negativity rate for minimal residual disease (MRD), showcasing the remarkable effects of Inaticabtagene Autoleucel within a short span.
 
Enduring remission: The 3-month post-treatment overall remission rate stood at 64.1%, with a 12-month sustained remission rate (DOR) of 80%. With a median follow-up of 8.0 months, the median relapse-free survival (RFS) period has not been reached. The one-year survival rates for overall infused patients, those achieving complete response (CR)/complete response with incomplete hematological recovery (CRi) within 3 months, and those reaching CR/CRi at 3 months were 67.9%, 72.0%, and 85.6%, respectively.
 
Good safety profile: The incidence rate of ≥3-grade cytokine release syndrome (CRS) was only 10.3%, and that of ≥3-grade immune effector cell-associated neurotoxicity syndrome (ICANS) was merely 7.7%. Moreover, patients recovered post-treatment without complications.
 
Furthermore, data from over 100 patients validated the clinical efficacy and safety of Inaticabtagene Autoleucel, affirming its robustness and offering renewed hope to a larger patient population. This breakthrough treatment provides a new avenue for tackling challenging diseases and is poised to revolutionize the landscape of hematologic cancer therapy.
 
#CARTRevolution #InaticabtageneAutoleucel #HematologicCancerTherapy #ClinicalBreakthrough #ChinaHematologyConference #JCIS #BAllTreatment #MedicalAdvancements #CancerResearch #TreatmentInnovation #InaticabtageneAutoleucel #Autoleucel #ChineseCART #CARTTherapy #cancer #Bloodcancer #MedicineinCHINA #Medicaltourismo #Advancedmedicine #cancertherapy

1 year 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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