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5 months ago Myeloma , CAR-T

2024 EBMT : China’s First RRMM CAR-T Therapy Equecabtagene Autoleucel: Efficacy Unaffected by Patients’ Baseline sBCMA Plasma Levels

RRMM

In recent years, CAR-T cell therapy targeting BCMA has emerged as a groundbreaking treatment for multiple myeloma, offering new hope to patients. At the 50th European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting, held from April 14-17, 2024, in Glasgow, the team led by Professor Qiu Lugui presented the latest subgroup analysis results from the FUMANBA-1 study (Abstract OS10-04) on China’s first BCMA-targeted CAR-T therapy, Iquilencel (CT103A).

BCMA (B-cell maturation antigen) is a promising therapeutic target for multiple myeloma (MM), with soluble BCMA (sBCMA) levels in the blood reflecting tumor burden. High sBCMA levels can interfere with the effectiveness of BCMA-targeted therapies, including CAR-T, by competing with cell-surface BCMA for binding, which can lead to reduced efficacy. In contrast, Iquilencel has been designed to minimize the impact of sBCMA on treatment outcomes through careful selection of its single-chain variable fragment (scFv).

The FUMANBA-1 phase II study (NCT05066646) in Chinese patients with relapsed/refractory multiple myeloma (RRMM) has demonstrated that Iquilencel can induce deep and durable responses, with a complete response (CR) rate of 82.4% and a 12-month progression-free survival (PFS) rate of 85.5%. This study aimed to explore whether baseline serum sBCMA levels affect clinical outcomes following Iquilencel infusion.

### Study Methods and Results

The study used enzyme-linked immunosorbent assay (ELISA) to measure serum sBCMA levels and digital droplet PCR (ddPCR) to monitor CAR transgene copy numbers in patients’ peripheral blood. Baseline serum sBCMA levels were classified into high (≥225.1 ng/mL) and low (<225.1 ng/mL) groups. Results showed that high sBCMA levels were significantly associated with high tumor burden, advanced R-ISS and DS stages, and high BCMA expression. However, there were no significant differences in CAR-T cell expansion, AUC (Area Under the Curve) during the first 28 days, or cell persistence between the high and low sBCMA groups.

Patients with high baseline sBCMA levels had overall response rates (ORR) and ≥CR rates of 100% and 80%, respectively, compared to 97.8% and 84% in the low sBCMA group. Analysis showed no significant correlation between baseline characteristics (including sBCMA levels) and CR/sCR achievement. Additionally, there were no significant differences in minimal residual disease (MRD) negativity rates, 18-month sustained MRD negativity rates, PFS, and overall survival (OS) between the two groups.

### Conclusion

The findings from the FUMANBA-1 study indicate that Iquilencel’s efficacy is not influenced by baseline sBCMA levels, making it a universally applicable and promising treatment option for RRMM patients. Its unique fast-dissociation and low-exhaustion properties, similar to those of healthy T-cell receptors, enable Iquilencel to remain effective and persistent in patients’ bodies regardless of sBCMA levels.

Professor Qiu Lugui from the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, and Professor Li Chunrui from Tongji Hospital, Huazhong University of Science and Technology, noted, “sBCMA is an important biomarker of tumor burden in multiple myeloma and a key factor influencing prognosis. Accumulation of sBCMA can inhibit the function of BCMA CAR-T cells. However, our study shows that Iquilencel can overcome the challenges posed by high baseline sBCMA levels, providing significant and lasting responses for RRMM patients.”

These results underscore Iquilencel as an ideal treatment choice for RRMM, offering hope for more effective and long-lasting therapeutic outcomes.

🎉🎉To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!

WhatsApp: +8613717959070

Email: doctor.huang@globecancer.com

#EBMT2024 #CAR_T #MultipleMyeloma #Iquilencel #EquecabtageneAutoleucel #sBCMA #CancerResearch #Immunotherapy #MedicalBreakthrough #Biopharmaceuticals

6 months ago CAR-T

#EBMT / #EHA Leading the Frontiers of Medicine: China’s Top Medical Expert Explains the Groundbreaking CAR-T Cell Therapy

Expert:Huang He

Chief Physician and Doctoral Supervisor.

Currently serves as the Director of the Hematology Institute at Zhejiang University, Director of the Zhejiang Provincial Engineering Research Center for Stem Cell and Cellular Immunotherapy, Chief Scientist for the “Hematology and Immunology Diseases” division at the Liangzhu Laboratory, and Director of the Bone Marrow Transplantation Center at the First Affiliated Hospital of Zhejiang University School of Medicine.

He is the Vice Chairman of the Asia Cell Therapy Organization and Deputy Leader of the Hematopoietic Stem Cell Application Group of the Hematology Branch of the Chinese Medical Association.

He has published over 300 papers (including over 200 as corresponding author) in journals such as The New England Journal of Medicine, Nature, Cell Metabolism, Lancet Haematology, Blood, and Leukemia.

He has received 17 provincial and ministerial-level awards and holds 23 authorized invention patents.

In the past five years, he has served as chairperson, invited speaker, and oral presenter at over 60 international conferences. As the conference chair, he organized the Asia-Pacific International Bone Marrow and Hematopoietic Stem Cell Transplantation Conference in Hangzhou in 2005 and 2014.

He is the chief editor of “CAR-T Cell Immunotherapy” and “Hematology” published by People’s Medical Publishing House.

He serves on the editorial boards and committees of multiple international journals and organizations.

To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in Chinafor preliminary evaluation!

WhatsApp:+8613717959070
Email: doctor.huang@globecancer.com

#MedicalInnovation #CAR_Therapy #Hematology #MedicalBreakthrough #ExpertTalks #CuttingEdgeMedicine #cart #EHA2024

6 months ago CAR-T , Myeloma

#EBMT / The Success Story of Equecabtagene Autoleucel: The World’s First Fully Human CAR-T for Multiple Myeloma

Multiple Myeloma

In recent years, CAR-T cell therapy has made groundbreaking progress in the field of relapsed/refractory multiple myeloma (RRMM), offering hope to patients struggling with limited treatment options. Recent data shows that Equecabtagene Autoleucel achieved an impressive complete response (CR) rate of 82.4% in Chinese clinical trials, garnering widespread attention for its outstanding efficacy.

### Breakthrough Research Findings

At the upcoming 50th Annual Meeting of the European Group for Blood and Marrow Transplantation (EBMT) in the UK, a study titled “Matching-Adjusted Indirect Comparison of Effective Characteristics Among Different BCMA Targeting CAR-T in Treatment of Relapsed or Refractory Multiple Myeloma (MAIC)” will be presented. This study compares the efficacy of four BCMA-targeted CAR-T products, revealing that Equecabtagene Autoleucel’s overall response rate (ORR) and CR rate are significantly superior to those of other comparators, especially in terms of CR rate.

### Clinical Performance of Equecabtagene Autoleucel

Equecabtagene Autoleucel is the world’s first fully human CAR-T product approved for marketing, having received priority review approval in China on June 30, 2023. The approval is based on results from the FUMANBA-1 Ib/II clinical study conducted across 14 centers in China. The study demonstrated that among 91 RRMM patients who had not previously received CAR-T therapy and had relapsed after multiple lines of treatment, Equecabtagene Autoleucel achieved a sCR/CR rate of 82.4%, with 97.8% of patients reaching minimal residual disease (MRD)-negative status.

### Pharmacodynamics and Pharmacokinetics Advantages

Compared to other BCMA-targeted CAR-T products, Equecabtagene Autoleucel shows significant advantages in pharmacodynamics and pharmacokinetics. Data indicates that Equecabtagene Autoleucel has a median time to response (TTR) of 15 days, and 62.3% of patients maintained CAR-T cell persistence for over 6 months. These findings suggest that Equecabtagene Autoleucel not only acts quickly but also remains effective in the body for an extended period, providing long-lasting therapeutic benefits.

### Structural Advantages Unveiled

Equecabtagene Autoleucel’s design includes unique structural advantages that minimize CAR-T cell exhaustion within the patient’s body. Research shows that Equecabtagene Autoleucel’s dissociation constant (Kd) is close to the natural dissociation kinetics of human T cells, with a dissociation time of about 6 minutes. This allows CAR-T cells to efficiently activate, kill, and proliferate within the body. In contrast, other BCMA-targeted CAR-T products have lower dissociation constants and longer dissociation times, which can lead to CAR-T cell exhaustion and reduced longevity.

### Long-Term Efficacy Outlook

Equecabtagene Autoleucel’s excellent performance in clinical trials brings new hope to RRMM patients. The long-term efficacy data in Chinese patients are particularly noteworthy. As time progresses, further clinical data will continue to validate Equecabtagene Autoleucel’s efficacy and safety, offering more effective treatment options for RRMM patients worldwide.

The success of Equecabtagene Autoleucel is not only due to its remarkable clinical efficacy but also the extensive scientific research and innovative technology behind it. This groundbreaking therapy sheds new light on the treatment of multiple myeloma and paves the way for future advancements in CAR-T cell therapy.

To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!

WhatsApp: +8613717959070

Email: doctor.huang@globecancer.com

#CART #MultipleMyeloma #EquecabtageneAutoleucel #CancerTreatment #Biopharmaceuticals #MedicalBreakthrough #Oncology #InnovativeTherapies #ClinicalResearch #HealthAdvancements

9 months ago Myeloma

#EBMT Conference Reveals the Best CAR-T Therapy for Multiple Myeloma – Equecabtagene Autoleucel

Multiple myeloma

Introduction:

In recent years, there has been a breakthrough in the research of #CART therapy for relapsed and refractory #multiplemyeloma (RRMM). This treatment method holds promise to address the challenges of inadequate response depth and short duration of response in #RRMM patients, offering hope for achieving minimal residual disease (#MRD) negativity and functional cure in this population.

Key Findings at EBMT:

The upcoming 50th European Society for Blood and Marrow Transplantation (EBMT) congress is set to unveil abstracts shedding light on the efficacy of targeted #BCMA CAR-T therapies. A recent abstract titled “Indirect Comparison of the Effectiveness of Targeted BCMA CAR-T Products in RRMM (#MAIC)” for the first time reveals efficacy comparisons among four BCMA CAR-T products. The study demonstrates that Equecabtagene Autoleucel outperforms other BCMA CAR-T therapies in terms of overall response rate (#ORR) and complete response (#CR) rate, offering significant hope for RRMM patients.

#Equecabtagene Autoleucel: Pioneering Fully-human BCMA #CARTTherapy:

#EquecabtageneAutoleucel, the world’s first approved Fully-human BCMA CAR-T therapy, received priority review and approval in China on June 30, 2023. The MAIC analysis underscores its favorable efficacy. This article provides a systematic analysis of the efficacy data of Equecabtagene Autoleucel in the Chinese population over the past two years, as revealed in the dynamic disclosures at various international academic conferences post-approval.

Efficacy Data Highlights:

– In the #FUMANBA-1 Ib/II clinical study conducted in China, the sCR/CR rate reached an impressive 82.4% among RRMM patients.

– The latest data presented at the 2023 International Myeloma Society (#IMS) conference demonstrated a MRD negativity rate of 97.8% among the enrolled patients, indicating substantial tumor burden reduction.

– With a median follow-up of 18.07 months, long-term efficacy data showcased remarkable outcomes, including a median PFS not yet reached, 12-month continuous MRD negativity rate of 81.7%, and 12-month PFS rate of 85.5%.

Differentiating Factors:

– Equecabtagene Autoleucel exhibited shorter median time to response (#TTR) compared to other CAR-T therapies, indicating faster onset of action.

– The dissociation kinetics of Equecabtagene Autoleucel closely resemble those of natural T cells, facilitating efficient activation, killing, and proliferation within the body.

– Its rapid dissociation pattern minimizes CAR-T cell exhaustion, ensuring sustained efficacy and long-term surveillance against tumor recurrence.

Conclusion:

The emergence of Equecabtagene Autoleucel heralds a new era in CAR-T therapy for RRMM, offering superior efficacy and durable responses. With its unique structural advantages and promising clinical data, Equecabtagene Autoleucel stands as a beacon of hope for RRMM patients worldwide, bringing them closer to achieving disease control and improved quality of life.

To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!

Email: doctor.huang@globecancer.com

WhatsApp: +8613717959070

#chineseMedicine #chineseresearch #cancerresearch #cancertreatment #myeloma #bloodtumor #cancer #cancerreseach

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2024 EBMT : China’s First RRMM CAR-T Therapy Equecabtagene Autoleucel: Efficacy Unaffected by Patients’ Baseline sBCMA Plasma Levels