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2 weeks ago Myeloma

Breaking Barriers: Equecabtagene Autoleucel Revives Hope for International RRMM Patients – Multiple Myeloma

Multiple Myeloma

Relapsed/refractory multiple myeloma (RRMM) presents a significant challenge worldwide, representing 13% of all blood cancers. Despite advances in treatment, many patients face poor outcomes and limited options. However, a groundbreaking CAR-T therapy, Equecabtagene Autoleucel, has recently demonstrated its life-changing potential in overcoming this medical impasse.

In February 2024, a 70-year-old patient from Kyrgyzstan, diagnosed with multiple myeloma 17 years ago, arrived at a Hospital of Chinese Xi’an seeking relief from severe pain and disease progression. The patient had undergone multiple treatments over the years, including chemotherapy and radiotherapy, but his condition continued to deteriorate with extensive bone destruction and kidney disease caused by the cancer.

Given the severity of his condition and the failure of previous treatments, he was selected for Equecabtagene Autoleucel therapy. After a series of preparatory treatments, the patient received CAR-T cell infusion in April 2024, and the results were remarkable. Within just one month, his myeloma cells were undetectable, and he achieved a complete response (CR) with no signs of minimal residual disease (MRD). The treatment was not only effective but also safe, with only mild side effects such as grade 1 cytokine release syndrome (CRS), which was easily managed.

This case exemplifies the transformative power of Equecabtagene Autoleucel, which has shown a 98.9% overall response rate (ORR) in clinical trials, with a CR rate of over 82%. It offers a beacon of hope for RRMM patients, particularly those who have exhausted conventional treatment options.

As one of China’s premier CAR-T therapies, Equecabtagene Autoleucel is breaking barriers, providing a new lease on life for patients globally. With its impressive safety profile and unparalleled efficacy, it is poised to play a pivotal role in extending survival and improving quality of life for those battling RRMM. This therapy is not only revolutionizing cancer treatment but also proving to be a lifeline for patients who previously faced limited options.

🎉🎉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

#MultipleMyeloma #CARTTherapy #CancerTreatment #MedicalInnovation #GlobalHealthcare #HopeForPatients #ChinaMedicalBreakthroughs #EquecabtageneAutoleucel #CAR_T #RRMM

2 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

2 months ago Myeloma

2024 EHA | Breaking Through Multiple Myeloma Treatment Bottlenecks: Significant Advances of Equecabtagene Autoleucel in High-Risk NDMM Patients

Multiple Myeloma

Multiple Myeloma (MM) is a malignant plasma cell disorder and one of the most common hematologic malignancies. In China, approximately 20,000 new cases of newly diagnosed multiple myeloma (NDMM) are reported annually, with a median age at diagnosis over 60 years. It is reported that Chinese MM patients generally exhibit higher rates of cytogenetic abnormalities, with an incidence rate exceeding 40%, which is significantly higher than in Western countries.

High-risk MM patients often respond poorly to existing treatment regimens and face limited treatment options. Many elderly patients are frail and have multiple comorbidities, making them less tolerant of the adverse reactions associated with current therapies, particularly autologous stem cell transplantation (ASCT). Once the disease progresses to a refractory/relapsed state, the combination of advanced age, frailty, and high-risk cytogenetic abnormalities leads to limited salvage treatment options, worsening efficacy, and poor prognosis. Thus, selecting effective frontline therapy for NDMM patients, especially high-risk elderly patients unsuitable for transplantation, is a pressing clinical need, requiring innovative therapies to supplement existing treatments. The new generation of cell immunotherapies, exemplified by Equecabtagene Autoleucel, holds promise to fill this gap and potentially become a breakthrough for high-risk NDMM.

In the FUMANBA-1 study, which included 69.5% high-risk patients, Equecabtagene Autoleucel achieved an ORR of 96.1% and has been approved in China for treating third-line or later relapsed/refractory multiple myeloma (R/R MM) patients. This EHA meeting is the first to present oral data on the efficacy and safety of Equecabtagene Autoleucel in the FUMANBA-2 study for high-risk, newly diagnosed, transplant-ineligible MM patients.

### Study Introduction

FUMANBA-2 is a multicenter, open-label, single-arm Phase I study designed to evaluate the efficacy and safety of Equecabtagene Autoleucel in transplant-ineligible NDMM patients with 100% high-risk features (defined by mSMART 3.0: RISS Stage III, double-hit, or triple-hit). Patients received four cycles of induction therapy, including the VRd regimen (Bortezomib, Lenalidomide, Dexamethasone), the VCD regimen (Bortezomib, Cyclophosphamide, Dexamethasone), or the PAD regimen (Bortezomib, Doxorubicin, Dexamethasone). After the third cycle of induction therapy, T cells were collected from patients unsuitable for ASCT and Equecabtagene Autoleucel was prepared. After lymphodepletion, patients received a single infusion of Equecabtagene Autoleucel at a dose of 1.0 x 10^6 CAR-T cells/kg. The primary efficacy endpoints were the proportion of MRD-negative patients and progression-free survival (PFS). Secondary endpoints included objective response rate, duration of response, safety, pharmacokinetics, and pharmacodynamics.

### Study Results

As of January 25, 2024, 16 patients received Equecabtagene Autoleucel, with a median age of 58.5 years (51-69) and a median follow-up time of 13.1 months (7.9-24.3). All patients had high-risk cytogenetics, with 62.5% (10/16) being double-hit, 12.5% (2/16) being triple-hit, and 25% (4/16) having extramedullary disease. 37.5% (6/16) were R-ISS Stage III, with one patient each combining R-ISS Stage III with double-hit and triple-hit characteristics.

The median follow-up time after Equecabtagene Autoleucel infusion was 7.46 months (2.8-18.1). The median PFS was not reached, with a 12-month PFS rate of 84.4% (95% CI: 49.31-96.00). All subjects achieved MRD negativity, with 71.4% (95% CI: 25.8-92.0) maintaining MRD negativity for over 12 months. The objective response rate (ORR) was 100%, with 93.8% (15/16) achieving stringent complete response (sCR).

Grade 1-2 cytokine release syndrome (CRS) occurred in 68.8% (11/16) of patients, with no grade 3 or higher CRS, immune effector cell-associated neurotoxicity syndrome (ICANS), or neurotoxicity. The most common grade 3 or higher drug-related adverse events were hematologic, with a 25.0% (4/16) incidence of grade 3 or higher infectious disease adverse events.

The median peak CAR copy number in peripheral blood was reached on day 10 (7-21) post-infusion, with a median peak level of 79,681.299 copies/μg gDNA. 81.25% (13/16) of patients achieved free B cell maturation antigen (sBCMA) clearance within one month post-infusion. Median peak levels of inflammatory cytokines IL-6, CRP, and ferritin were 64.28 pg/mL (9.12-3017.83), 49.30 mg/L (3.66-117.30), and 553.35 ng/mL (68.10-2349.00), respectively. The median peak times for IL-6 and CRP were day 7 and day 10, respectively, with no significant change in serum ferritin levels compared to pre-infusion.

### Study Outlook

The FUMANBA-2 study of Equecabtagene Autoleucel demonstrates the efficacy and safety of a novel fully human BCMA CAR-T therapy in high-risk, transplant-ineligible, newly diagnosed multiple myeloma patients. This is the first international report of CAR-T therapy as frontline treatment in this specific population. The study highlights the potential application of cell immunotherapy in the MM field. Compared to traditional chemotherapy and new drug treatments, frontline CAR-T therapy for NDMM has the potential to further improve response rates, extend survival, and improve prognosis, particularly for high-risk cytogenetic abnormalities and high tumor burden. For elderly and frail patients who are unsuitable for hematopoietic stem cell transplantation, CAR-T therapy may fill the treatment gap to some extent. The one-time treatment approach, as opposed to continuous chemotherapy or multiple transplants, offers patients better quality of life and treatment convenience. Although CAR-T therapy carries risks such as CRS and neurotoxicity, these side effects are manageable in many studies, and safety improves with treatment experience and management strategies. Bringing CAR-T therapy to the frontline provides patients with more diverse and promising treatment options. However, large-scale, long-term follow-up studies are needed to validate its long-term efficacy and survival benefits, and further exploration and optimization are required for the best administration timing, regimen, and duration.

In summary, the FUMANBA-2 study of Equecabtagene Autoleucel shows significant treatment potential in newly diagnosed, transplant-ineligible multiple myeloma patients. With accumulating research evidence and advances in CAR-T technology, we anticipate CAR-T therapy will benefit more patients in the future.

🎉🎉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

#EquecabtageneAutoleucel #MultipleMyeloma #MMTreatment #HighRiskMM #NDMM #CAR_Therapy #Immunotherapy #BloodCancer #OncologyResearch #EHA2024 #CancerBreakthrough #CellTherapy #MyelomaTreatment #ClinicalTrials #InnovativeMedicine #HealthcareAdvancements

2 months ago Myeloma

IMWG Releases 2024 RRMM CAR-T Guidelines: Equecabtagene Autoleucel Becomes China’s First Included CAR-T Therapy

###IMWG Releases 2024 RRMM CAR-T Guidelines: Equecabtagene Autoleucel Becomes China’s First Included CAR-T Therapy

IMWG

###EquecabtageneAutoleucel: Leading China’s CAR-T Therapy to Global Breakthroughs

In the latest guidelines released by the International Myeloma Working Group (IMWG) in 2024, Equecabtagene Autoleucel, a CAR-T therapy independently developed in China, has been officially included. This marks the first and only Chinese CAR-T product included in the global treatment guidelines for relapsed and refractory multiple myeloma (RRMM). This milestone signifies a major breakthrough for China in the field of CAR-T therapy and brings new hope to RRMM patients worldwide.

####CARTTherapy: A New Hope for Multiple Myeloma Patients

Multiple myeloma (MM) is a challenging blood cancer to treat, with approximately 176,404 new cases and 117,077 related deaths globally in 2020. Traditional therapies have limited effectiveness for relapsed and refractory MM patients. The emergence of CAR-T cell therapy has brought significant treatment progress for this group. CAR-T therapy reprograms the patient’s own T cells to recognize and kill cancer cells, achieving remission rates of 73%-98%.

#### Equecabtagene Autoleucel: A Unique Fully Human CAR-T Product

Equecabtagene Autoleucel is the only fully human CAR-T product included in the “2024 IMWG RRMM CAR-T Guidelines.” Compared to the other two included CAR-T products, which are derived from mice and alpacas (ide-cel and cilta-cel), Equecabtagene Autoleucel’s unique design reduces immunogenicity while enhancing efficacy. Since its launch in China, it has demonstrated significant therapeutic effects and safety, with a total response rate of 98.9%, a complete response rate of 82.4%, and a one-year progression-free survival rate of 85.5%.

#### Global Recognition: The Significance of IMWG Guidelines

The IMWG guidelines are developed by top global experts in multiple myeloma, providing the latest research findings and best practice recommendations for CAR-T therapy. The “2024 IMWG RRMM CAR-T Guidelines” not only recognize the excellent efficacy of Equecabtagene Autoleucel but also offer detailed guidance on patient selection and safety management, covering the management of unique toxicities such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) during treatment.

#### Looking Ahead: Benefiting More Patients

The inclusion of Equecabtagene Autoleucel in the IMWG guidelines showcases China’s leading position in CAR-T therapy development and will help further expand its application globally. This achievement is a significant breakthrough for China’s biopharmaceutical field and brings new treatment hope for RRMM patients worldwide. With ongoing clinical research and real-world data accumulation, Equecabtagene Autoleucel is expected to benefit more patients domestically and internationally, continuously advancing CAR-T therapy.

In the global treatment landscape for multiple myeloma, Equecabtagene Autoleucel is at the forefront, bringing new hope to countless patients. Stay tuned to Equecabtagene Autoleucel and witness the outstanding innovation and global impact of China’s biopharmaceutical industry!

🎉🎉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

#EquecabtageneAutoleucel #CART #MultipleMyeloma #CancerTreatment #Biopharmaceuticals #IMWG2024 #MedicalBreakthrough #InnovativeTherapy #GlobalHealthcare #CancerResearch #PatientHope #ChineseMedicine #Immunotherapy

2 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

2 months ago CAR-T

IASO Bio’s Equecabtagene Autoleucel Injection Wins “China First-in-Class” Award, Showcasing China’s Biopharmaceutical Innovation

Multiple myeloma

On June 28, 2024, at the “2024 First CBA-China Annual Conference” hosted by the Chinese Biopharmaceutical Association, USA, at the Suzhou International Expo Centre, IASO Bio’s Equecabtagene Autoleucel Injection was honored with the “China First-in-Class Targeted Drug” award. This award recognizes the drug’s outstanding innovation and therapeutic efficacy, making it the only brand in the cell therapy category to receive this prestigious honor. This accolade not only highlights IASO Bio’s innovative capabilities and research strength in the biopharmaceutical field but also represents the rise of China’s biopharmaceutical industry on a global scale.

In recent years, China’s innovation capabilities in the biopharmaceutical field have significantly improved. From 2015 to 2021, most “first-in-class” drugs on the market were dominated by foreign companies. However, from 2021 to 2023, data on approved new drugs in China showed that among 35 “first-in-class” products, nearly half were from domestic companies, with four being independently developed. This not only marks the rise of China’s innovative drugs but also demonstrates China’s increasing competitiveness in the global biopharmaceutical industry.

The success of IASO Bio’s Equecabtagene Autoleucel Injection is the best embodiment of the innovative power of China’s biopharmaceutical industry. In the future, IASO Bio aims to leverage more international platforms to advance biopharmaceutical technology in China and worldwide, contributing significantly to human health.

About IASO Bio

IASO Bio is a biopharmaceutical company focused on the research, development, production, and sale of innovative cell therapies. The company bases its innovation on the development of cell therapies for hematologic malignancies and antibody drugs, expanding into autoimmune diseases. IASO Bio possesses full capabilities from early discovery, clinical development, and regulatory submission to commercial production.

The company has more than ten innovative drug candidates in various stages of development, among which Equecabtagene Autoleucel Injection (a fully human BCMA CAR-T product) has been approved for marketing by the National Medical Products Administration (NMPA) and has received FDA approval for clinical trials in the United States for the treatment of relapsed/refractory multiple myeloma.

With a strong management team, an innovative product pipeline, in-house GMP production facilities, and outstanding clinical development capabilities, IASO Bio is dedicated to providing transformative, curative innovative therapies, bringing hope for a cure to patients in China and worldwide.

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

#IASOBio #InnovationInMedicine #ChinaFirstInClass #EquecabtageneAutoleucel #GlobalHealth #multiplemyeloma #RRMM

5 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

9 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.

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