High Risk Multiple Myeloma Solution and Chinese Expert Consensus

**High Risk Multiple Myeloma Solution and Chinese Expert Consensus**

Multiple Myeloma

High risk multiple myeloma (HRMM) refers to patients with multiple myeloma whose overall survival is less than 2 to 3 years under current standard treatments.

In 2024, the Chinese Society of Clinical Oncology’s Multiple Myeloma Expert Committee and the Chinese Anti-Cancer Association’s Hematologic Oncology Committee, organized by relevant experts, developed the “Chinese Expert Consensus on the Diagnosis and Treatment of High Risk Multiple Myeloma (2024 Edition),” which was officially published in the *Chinese Journal of Hematology* in May 2024. This consensus defines HRMM, outlines high-risk factors and risk stratification systems, and provides key treatment recommendations for HRMM, aiming to improve the quality of life and prognosis for HRMM patients in China.

**Definition of HRMM**

There is currently no precise definition of HRMM. Referencing the International Myeloma Working Group (IMWG)’s definition, the Chinese Expert Committee considers HRMM patients as those with an overall survival (OS) of less than 3 years after receiving autologous hematopoietic stem cell transplantation (auto-HSCT) or less than 2 years if they have not received auto-HSCT. Patients with OS of less than 2 years after receiving auto-HSCT are classified as ultra-high risk multiple myeloma (UHRMM) patients.

**Prognostic Factors of HRMM**

The biological characteristics of MM tumor cells and treatment response are key determinants in identifying HRMM.

**Static Prognostic Factors of MM**

1. **Genetic High-Risk Factors:**

   In the context of genetic high-risk factors, cytogenetic abnormalities are core indicators in the MM risk stratification system, but there is still some debate over the definition of high-risk cytogenetic abnormalities (HRCAs). The “National Comprehensive Cancer Network (NCCN) Guidelines (2024.v1)” indicate that the presence of multiple HRCAs correlates with a poorer prognosis. Fluorescence in situ hybridization (FISH) is currently the main genetic testing technique for MM, and next-generation sequencing can be performed if conditions allow (TP53 mutations have a significant impact on prognosis, while the effects of KRAS, NRAS, DIS3, BRAF, and FAM46C are less clear). All these genetic tests require enrichment and selection of plasma cells.

2. **Non-Genetic High-Risk Factors:**

   Confirmed non-genetic prognostic factors include International Staging System (ISS) stage III, extramedullary disease excluding bone lesions, circulating plasma cells, high plasma cell proliferation index, elevated lactate dehydrogenase (LDH), frailty, renal insufficiency, and thrombocytopenia.

**Dynamic Prognostic Factors of MM**

1. **Duration of Initial Treatment Response:**

   The duration of response to initial treatment is a crucial dynamic prognostic factor for MM. Patients who received auto-HSCT followed by maintenance therapy and experienced relapse/progression within less than 2 years are classified as HRMM; for those who did not receive auto-HSCT, relapse within less than 18 months after starting treatment also indicates HRMM. Functional high risk refers to MM patients without known genetic high-risk factors at diagnosis who experience early progression within 18 months after the start of treatment.

2. **Depth of Initial Treatment Response:**

   The depth of response to initial treatment is another important dynamic prognostic factor for MM. Patients who achieve negativity for minimal residual disease (MRD) in both bone marrow and imaging studies have the best survival outcomes. Achieving MRD negativity can partially overcome the adverse prognosis associated with high-risk cytogenetics. Continuous dynamic MRD monitoring has greater clinical value than a single MRD result, as sustained MRD negativity for more than 12 months can translate into long-term survival.

The Expert Committee considers newly diagnosed MM to be classified as HRMM if any of the following criteria are met:

1. R-ISS stage III, extramedullary disease excluding bone lesions, presence of circulating plasma cells (plasma cell leukemia is defined as ≥5% plasma cells in peripheral blood), presence of one or more HRCAs [t(4;14), t(14;16), t(14;20), del(17/17p), 1q21 gain/amplification, del(1p32), TP53 mutation], although 1q21 gain alone does not define HRMM;

2. MM patients who have received auto-HSCT followed by maintenance therapy and experience relapse within less than 2 years from the start of treatment;

3. Patients who have not received auto-HSCT and experience relapse within less than 18 months from the start of treatment;

4. Functional high risk;

5. Extramedullary relapse/secondary plasma cell leukemia;

6. New occurrence of 1q21 gain/amplification and/or del(17/17p)/TP53 mutation at relapse.

**Treatment of HRMM**

**Principles of Treatment for Newly Diagnosed HRMM**

The standard treatment for HRMM has not yet been established. The overall treatment strategy includes:

1. Utilizing combination therapies with drugs that have different mechanisms of action;

2. Aiming to eradicate all tumor clones, with the goal of achieving and maintaining MRD negativity both inside and outside the bone marrow;

3. Implementing a treatment strategy that adjusts based on the effectiveness of the therapy;

4. Acknowledging that current treatment outcomes for HRMM are still unsatisfactory, and encouraging the exploration of experimental therapies.

**Treatment for Newly Diagnosed HRMM Suitable for Transplantation**

1. **Induction Therapy Before Transplantation:**

   For HRMM, induction therapy with the RVd regimen as a bridge to auto-HSCT has not met expectations in terms of depth of response and long-term prognosis, and achieving MRD negativity is more challenging compared to standard-risk patients. Some studies with novel drug-modified regimens have shown that patients with one HRCA receiving the KRd regimen (carfilzomib, lenalidomide, and dexamethasone) sequentially followed by auto-HSCT achieved similar MRD negativity rates and progression-free survival (PFS) as standard-risk patients, with no statistically significant difference. Meta-analyses indicate that incorporating a CD38 monoclonal antibody as part of the treatment backbone in early-line therapy provides clinical benefits for patients with HRCAs. For UHRMM patients, more intensive treatment regimens, such as the Dara-VRdC regimen (OPTIMUM/MUKnine study) and the Dara+KTD-PACE regimen (TT7 study), can be considered.

2. **Auto-HSCT:**

   Tandem transplantation involves performing a planned second auto-HSCT within 3–6 months after the first. It is recommended that HRMM patients collect sufficient hematopoietic stem cells for two auto-HSCTs during the first mobilization. Regardless of the response achieved after the first transplant, it is advised to perform the tandem transplant within six months. The conditioning regimen for both transplants typically includes high-dose melphalan.

3. **Consolidation Therapy:**

   If tandem transplantation is not performed, the original induction regimen can be continued for consolidation therapy for an additional 2–4 cycles.

4. **Maintenance Therapy:**

   For HRMM patients, maintenance therapy should consider a combination of proteasome inhibitors, immunomodulators, and CD38 monoclonal antibodies, in either dual or triple drug regimens. It is recommended to continue maintenance therapy until disease progression or intolerance.

5. **Allo-HSCT:**

   The long-term efficacy of allo-HSCT remains debatable and should only be considered within the context of clinical trials and for select high-risk patients.

#HRMM #AutoHSCT #CancerTreatment #MultipleMyeloma #InductionTherapy #TandemTransplantation #ConsolidationTherapy #MaintenanceTherapy #ProteasomeInhibitors #Immunomodulators #CD38MonoclonalAntibodies #AlloHSCT #UHRMM #NovelTherapies

Expert Consensus on the Treatment of HRMM

①Induction Therapy: For pre-transplantation induction therapy in HRMM, it is recommended to use a regimen based on CD38 monoclonal antibodies combined with proteasome inhibitors and immunomodulators. Recommended regimens include: Dara+KRd, Isa+KRd, Dara+VRd, and Isa+VRd. For patients who cannot tolerate a four-drug regimen, the KRd regimen is an alternative. For patients with significant extramedullary involvement (soft tissue or peripheral blood), additional cytotoxic drugs and, if necessary, radiotherapy can be added.

Therapy Regimens

②Auto-HSCT: Early auto-HSCT is the standard treatment for HRMM. For patients who receive auto-HSCT without significant adverse effects, tandem transplantation within six months post-transplant is recommended.

③Consolidation Therapy: For patients who do not undergo tandem transplantation, it is advised to continue consolidation therapy with the original induction regimen for 2–4 cycles.

④Maintenance Therapy: Maintenance therapy should involve a combination of proteasome inhibitors, immunomodulators, and CD38 monoclonal antibodies, either as dual or triple drug regimens. Therapy should continue until disease progression or intolerance.

⑤Clinical Research: Clinical studies targeting HRMM are encouraged, and it is recommended that HRMM patients prioritize enrollment in clinical trials.

**Treatment for Newly Diagnosed HRMM Not Suitable for Transplantation**

For MM patients not suitable for transplantation, an individualized treatment plan should be selected based on the patient’s fitness status score (IMWG GA score is recommended). For patients with good or moderate health, it is recommended to continue using the same regimen as for transplant-eligible patients. For frail patients, the VRd-lite (modified bortezomib + lenalidomide + dexamethasone) regimen and the DRd (daratumumab + lenalidomide + dexamethasone) regimen are currently the most commonly used first-line treatments.

**Treatment of Relapsed HRMM**

For patients with functional high risk and those defined as HRMM based on dynamic risk factors, re-induction regimens should include combinations of next-generation drugs or drugs with different mechanisms of action. Several clinical studies have shown that CAR-T cell (BCMA CAR-T) therapy can sustain efficacy in relapsed HRMM.

**Expert Consensus**

1. For relapsed HRMM patients, it is recommended to select combination regimens involving next-generation drugs or drugs with different mechanisms of action.

2. Patients with relapsed HRMM are encouraged to participate in clinical studies of CAR-T cell therapy or bispecific antibody immunotherapy.

**Summary**

For the treatment of HRMM, it is recommended to use multi-drug combination therapies with different mechanisms of action and bridge to auto-HSCT, aiming for deep and sustained MRD negativity and prolonging overall survival (OS) in patients. Currently, clinical trials of CAR-T cell therapy for newly diagnosed HRMM are being conducted, and combining auto-HSCT with CAR-T cell therapy can leverage the therapeutic benefits of both. Besides the BCMA target, CAR-T cell therapies targeting GPRC5D and FcRH5, as well as bispecific antibodies, have shown good efficacy in relapsed and refractory MM. New drugs and innovative diagnostic and therapeutic strategies, including immunotherapy, hold promise for overcoming the challenges in HRMM treatment.

🎉🎉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

#HighRiskMultipleMyeloma #HRMM #MultipleMyeloma #CancerTreatment #Hematology #Oncology #MedicalResearch #CancerCare #CancerAwareness #ChinaMedicalAdvances #AutoHSCT #MedicalConsensus #UHRMM #BloodCancer

#CancerPrognosis #GeneticRiskFactors #CancerResearch #MMTreatment #MRD #Hematology #CancerSurvival #PrognosticFactors

#CancerCriteria #Hematology #HighRiskMyeloma #PlasmaCellLeukemia #CancerRelapse #CytogeneticAbnormalities

#InductionTherapy #TandemTransplantation #ConsolidationTherapy #MaintenanceTherapy #ProteasomeInhibitors #Immunomodulators #CD38MonoclonalAntibodies #AlloHSCT #NovelTherapies

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3 months ago patient story

Light of Hope – The Starting Point for Multiple Myeloma Patients

### Light of Hope – The Starting Point for Multiple Myeloma Patients

Ms. Teresa sat in the comfortable seat of the apheresis room, watching the nurse gently insert the needle into her arm to draw the precious white blood cell samples. These white blood cells would become the core material for CAR-T therapy, engineered and then reintroduced into her body to become a powerful force against cancer.

In the operating room, machines hummed softly, precisely separating the T cells from Teresa’s body. These cells, which had faithfully performed their duty of protecting her body, would now be re-educated to become a precise strike team against cancer cells. Teresa closed her eyes and silently prayed that this apheresis would infuse her body with the strength to drive the disease out of her life.

The apheresis process lasted several hours, with medical staff carefully monitoring each step to ensure enough high-quality cells were collected. The extraction of these cells was not only a technical challenge but also a stringent test of the medical team’s professional capabilities.

After the apheresis was completed, Teresa felt somewhat relieved. She knew this was just the first step in a long treatment journey, but it was also an important starting point filled with hope. In the apheresis room, she felt the warmth and professionalism of the medical team, which filled her with confidence and hope for the future treatment.

Back in her ward, Teresa gently closed her eyes as she lay on the bed. She pondered how the coming days would unfold, hoping that this apheresis would bring her the strength to overcome the disease and regain her health.

Apheresis, as the first step of the treatment journey, marked a new chapter in Teresa’s brave fight against cancer and ignited a flame of hope for her future recovery.

#ThePathOfHope #FightingCancer #JourneyOfCARTTherapy #TogetherWithTongji #FullyHumanCART #HopeWithFUCASO #EquecelApproval #HealthReborn #UnitedInPrayer #MultipleMyeloma

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3 months ago Myeloma , patient story

希望之光-多发性骨髓瘤患者的起点

希望之光-多发性骨髓瘤患者的起点

Teresa女士坐在单采室的舒适座位上，注视着护士轻柔地在她手臂上穿刺，抽取宝贵的白细胞样本。这些白细胞将成为CAR-T治疗的核心材料，经过工程化后，将再次注入她体内，成为对抗癌症的力量源泉。

手术室内，机器轻声运转，精密地分离出Teresa身体中的T细胞。这些细胞，此前在她的身体内忠实执行着保护机体的职责，如今将被重新教育，成为一支针对癌细胞的精确打击队伍。Teresa闭上眼睛，心中默默祈祷这次单采能为她的身体注入战斗的力量，将病魔赶出她的生命。

单采过程持续了几个小时，医护人员细心地监控着每一个步骤，确保采集到足够数量和质量的细胞。这些细胞的提取不仅是技术上的挑战，更是对医疗团队专业能力的严格考验。

完成单采后，Teresa感到轻松了一些。她知道，这只是漫长治疗过程中的第一步，但也是希望之光的重要起点。在单采室内，她感受到了医护团队的温暖和专业，这让她对未来的治疗充满信心和希望。

回到病房，Teresa在床上轻轻闭上了眼睛。她思考着接下来的日子将如何展开，希望这次单采能为她带来战胜疾病的力量，让她重获新生。

单采，作为治疗之旅的第一步，铸就了Teresa勇敢抗癌的新篇章，也为她未来的康复之路点燃了希望的火光。

#希望之路 #ThePathOfHope #与癌症抗争 #FightingCancer #CART治疗之旅 #JourneyOfCARTTherapy #携手同济 #TogetherWithTongji #全人源CART #FullyHumanCART #FUCASO希望 #HopeWithFUCASO #EquecelApproval #健康重生 #HealthReborn #共同祈愿 #UnitedInPrayer #MultipleMyeloma

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3 months ago CAR-T

2024 EHA | New Generation BCL-2 Inhibitor Sonrotoclax Expected to Be a New Treatment Option for RRMM

**2024 EHA | New Generation BCL-2 Inhibitor Sonrotoclax Expected to Be a New Treatment Option for RRMM**

RRMM

The 29th Annual Meeting of the European Hematology Association (EHA) was held from June 13-16, 2024, in Madrid, Spain. During this event, the results of the study on the new-generation BCL-2 inhibitor Sonrotoclax (BGB-11417) combined with dexamethasone for the treatment of relapsed/refractory multiple myeloma (RRMM) patients with t(11;14) were presented.

**Ib/II Phase Study of Sonrotoclax (BGB-11417) Combined with Dexamethasone for the Treatment of RRMM with t(11;14)**

**Study Background**

The B-cell lymphoma-2 (BCL-2) protein helps multiple myeloma (MM) tumor cells evade apoptosis and promote cell survival. Studies have found that MM cells with t(11;14) have significantly higher BCL-2 protein expression compared to other cells. BCL-2 inhibitors can block anti-apoptotic mechanisms and induce cell apoptosis. Currently, data have shown that BCL-2 inhibitors have significant anti-MM potential in RRMM patients with t(11;14) who have failed multiple lines of treatment. However, to date, no BCL-2 targeted therapy has been approved for MM treatment.

Sonrotoclax (BGB-11417) is a new-generation BCL-2 inhibitor. Preclinical studies have found that it has over ten times the BCL-2 inhibitory ability of the first-generation BCL-2 inhibitors, a shorter half-life, and no dose accumulation. BGB-11417-105 (NCT04973605) is an ongoing Ib/II phase trial aimed at evaluating the efficacy and safety of Sonrotoclax combined with dexamethasone ± carfilzomib/daratumumab/pomalidomide in treating RRMM patients with t(11;14). The latest data from this study were reported at this EHA meeting.

**Study Design**

The enrolled patients were all RRMM with t(11;14), who had failed at least three treatments, including proteasome inhibitors (PI), immunomodulatory drugs (IMIDs), and anti-CD38 monoclonal antibodies, and were refractory/relapsed to the most recent treatment. In the first part, dose escalation cohorts, patients took 80, 160, 320, or 640 mg of Sonrotoclax daily, combined with 40 mg of dexamethasone weekly until intolerance, disease progression, or death. The primary endpoints were safety/tolerability, determining the maximum tolerated dose (MTD)/maximum assessed dose (MAD), and recommending the dose for the expansion phase (RDFE). The second part, dose expansion, primarily evaluated the tolerability and antitumor activity of Sonrotoclax combined with dexamethasone ± carfilzomib/daratumumab/pomalidomide.

**Study Results**

The initial report at 2023 ASH showed that Sonrotoclax (640 mg) was well tolerated, with no dose-limiting toxicities (DLTs) observed in any patients, establishing 640 mg as the RDFE. The overall response rate (ORR) for this cohort was 70%, and the rate of very good partial response (≥VGPR) was 40%.

Updated in this report: as of March 25, 2024, 32 patients received the RDFE dose of 640 mg Sonrotoclax combined with dexamethasone (10 in the first part and 22 in the second part). The median follow-up time was 4.6 months (0.1-19 months).

The median age of patients was 69 years (48-80 years), with a median of 3 prior lines of treatment (1-12 lines), and 28.1% had high-risk cytogenetic abnormalities. All patients had been exposed to PI and IMiD treatments, and 72% had been exposed to anti-CD38 monoclonal antibody treatments. 56% were PI-refractory, 72% were IMiD-refractory, 56% were anti-CD38 monoclonal antibody-refractory, and 47% were triple-refractory.

**Safety**

No patients experienced DLTs. The most common treatment-emergent adverse events (TEAEs) were fatigue and insomnia (28% each), diarrhea (22%), constipation, and nausea (16% each). Only 4 patients (13%) experienced hematologic TEAEs (grade 3 thrombocytopenia, grade 1 and 3 platelet count decrease, and grade 3 neutropenia). Two patients died, both unrelated to treatment (one due to pancreatic cancer complications and one due to liver cancer and liver failure).

**Efficacy**

Among the 24 evaluable patients, the ORR was 75%, with a ≥VGPR rate of 50%. The complete response (≥CR) rate was 21% (CR, n=4; sCR, n=1), with two patients achieving minimal residual disease (MRD) negativity (10^-5). The median time to response was 0.7 months, and the median duration of response (DOR) was 8 months. As of the follow-up, the longest DOR was 18 months.

**Conclusion**

Sonrotoclax (640 mg) combined with dexamethasone was well tolerated in heavily pretreated RRMM patients with t(11;14), with low rates of hematologic toxicity and infection. It provided deep and durable responses: ORR was 75%, ≥VGPR rate was 50%, and ≥CR rate was 21%. This study will continue to explore Sonrotoclax in combination with other novel agents.

**Interpretation by Professor Lu Jin**

The t(11;14) translocation is a common genetic abnormality in MM patients, present in approximately 15%-20% of newly diagnosed MM cases. Before the era of novel drugs, many researchers believed that patients with t(11;14) had favorable treatment outcomes and were classified as a standard-risk group. However, recent studies have found that patients with t(11;14) are less sensitive to bortezomib regimens, and even with the VRd regimen, patients with t(11;14) have significantly lower deep response rates (≥VGPR) and PFS benefits compared to other standard-risk patients. This suggests that t(11;14) may be an influencing factor for poor efficacy of novel drugs, necessitating other therapies to improve prognosis.

Studies have found that tumor cells with t(11;14) often have high BCL-2 expression and high sensitivity to BCL-2 inhibitors. The phase III CANOVA study demonstrated that venetoclax combined with dexamethasone resulted in deeper response rates (ORR 62% vs. 35%, p<0.001; ≥VGPR rate 39% vs. 14%, p<0.001) and longer median PFS (9.1 months vs. 4.9 months, p=0.237) compared to pomalidomide combined with dexamethasone in treating RRMM patients with t(11;14), though without significant statistical difference. The failure to meet the primary endpoint might be due to more patients in the control group not reaching IMWG-defined disease progression and thus being treated with new regimens, resulting in censored data in the initial PFS analysis. In the latest post-hoc analysis, including new treatment as an event in PFS, the analysis showed a significant statistical difference in median PFS (9.4 months vs. 4.0 months, p=0.003).

Therefore, the benefits of BCL-2 inhibitors still warrant further exploration. Sonrotoclax is a second-generation highly selective and potent BCL-2 inhibitor. In preclinical trials, Sonrotoclax had an IC50 for BCL-2 protein over ten times lower than that of the first-generation BCL-2 inhibitors (0.014 nM vs. 0.2 nM). It also showed ≥2000 times selectivity over BCL-XL, BCL-W, MCL-1, and BCL2A1 and stronger cytotoxicity against MM cell lines. Additionally, Sonrotoclax has a shorter half-life (approximately 4.5 hours), allowing more flexible exploration of rapid dose escalation plans without the risk of off-target toxicity due to drug accumulation.

The Ib/II phase study reported at this EHA meeting demonstrated that Sonrotoclax combined with dexamethasone was well tolerated in RRMM patients previously treated with multiple lines of therapy. The 640 mg RDFE dose achieved a 75% ORR, ≥VGPR rate of 50%, and ≥CR rate of 21%. We look forward to the release of more results from Sonrotoclax combination therapies. Additionally, as the proportion of t(11;14) in systemic light chain amyloidosis and plasma cell leukemia is higher than in MM, the exploration of BCL-2 inhibitors in these plasma cell diseases is also ongoing.

**Professor Lu Jin**

Chief Physician, Professor, Ph.D. Supervisor

Peking University People’s Hospital, Peking University Institute of Hematology

Specializes in clinical and laboratory research on multiple myeloma, primary systemic amyloidosis, lymphoma, and cellular immunotherapy.

General Secretary and Standing Committee Member of the Hematology Physician Branch of the Chinese Medical Doctor Association

President of the Hematology Physician Branch of the Beijing Medical Doctor Association

Vice Chairman of the Multiple Myeloma Professional Committee and the Histiocyte Disease Professional Committee of the Chinese Medical Doctor Association

Vice President of the Hematology Branch of the Chinese Society of Geriatrics and Chairman of the Multiple Myeloma Academic Committee

Deputy Leader of the Plasma Cell Group of the Hematology Branch of the Chinese Medical Association

Deputy Leader of the Multiple Myeloma and Related Diseases Professional Group of the Hematology Professional Committee of the Chinese Women Physicians Association

Member of the Chinese and International Primary Systemic Amyloidosis Collaboration Group

Member of the International Myeloma Working Group and the Asia-Pacific Myeloma Working Group

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

#Sonrotoclax #RRMM #BCL2Inhibitor #MultipleMyeloma #EHA29 #Hematology #NewTreatment #CancerResearch #2024EHA

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3 months ago CAR-T

Sustained 7-Month CR, Liver Extramedullary Disease Disappearance: Equecabtagene Autoleucel Brings High-Quality Survival Hope to Ultra-High-Risk RRMM Patients with Extramedullary Disease

### Sustained 7-Month CR, Liver Extramedullary Disease Disappearance: Equecabtagene Autoleucel Brings High-Quality Survival Hope to Ultra-High-Risk RRMM Patients with Extramedullary Disease

RRMM Patients

In December 2019, a man in his 50s was diagnosed with multiple myeloma (MM) at a hospital in Shenzhen, China. The patient had high-risk cytogenetic abnormalities (17p deletion) and underwent various treatments over more than three years, including proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and CD38 monoclonal antibodies. Despite these treatments, the patient experienced a second relapse. This relapse was characterized by a P53 gene mutation and liver extramedullary invasion, classifying it as an ultra-high-risk situation. Although the patient initially refused an autologous stem cell transplant (ASCT), he was eventually persuaded to collect sufficient stem cells. However, due to concerns about the side effects of high-dose chemotherapy, he opted for CAR-T therapy.

### Personalized Treatment: From ASCT to CAR-T Therapy

Under the care of Professor Chen’s team at the hospital, the patient was evaluated for CAR-T therapy. Despite the risks, he underwent the treatment and showed significant improvement. As of March 2024, he has maintained a complete response (CR) for seven months, with PET/CT scans indicating the disappearance of liver extramedullary disease.

#### Patient Background

– **Age**: 54

– **Initial Symptoms**: Back pain after exercise

– **Diagnosis**: Multiple Myeloma (IgA κ type, DS I A stage, ISS I stage, R-ISS II stage, mSMART high-risk)

### Treatment Journey

– **2019**: Diagnosed with MM; high-risk cytogenetic abnormality (17p deletion)

– **2020-2022**: Treated with PIs, IMiDs, and CD38 monoclonal antibodies

– **Early 2023**: Second relapse with P53 mutation and liver extramedullary disease

– **July 2023**: Stem cell collection for ASCT

– **August 2023**: Initiated CAR-T cell (Equecabtagene Autoleucel) therapy

– **September 2023**: Discharged with strict complete response (sCR)

– **March 2024**: PET/CT scan confirms sustained complete response (CR) with no liver lesions

### Breakthrough Results and Future Prospects

CAR-T therapy has emerged as a promising treatment for relapsed and refractory multiple myeloma (RRMM), especially for patients resistant to conventional therapies. This case highlights the importance of personalized treatment plans, considering disease factors, previous treatment outcomes, and patient preferences. Equecabtagene Autoleucel (IKEA-Lunsay) CAR-T therapy has given this high-risk patient a new lease on life and holds the potential to offer hope to many more MM patients in China.

By showcasing such success stories, we aim to raise awareness about the advancements in CAR-T therapy and its significant impact on improving the quality of life for MM patients. This breakthrough not only marks a significant achievement for the hospital but also signals a new era of hope for countless MM patients.

🎉🎉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

#MedicalBreakthrough #CARTTherapy #MultipleMyeloma #CancerTreatment #PatientSuccess #HealthcareInnovation #CancerResearch #MMTreatment #LifeSavingTherapies #MedicalAdvancements #HealthcareHeroes #InnovativeMedicine #CancerCare #HopeForMM #CancerAwareness

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3 months ago Myeloma , CAR-T

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

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

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3 months ago Myeloma

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

**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

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3 months ago CAR-T , Myeloma

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

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4 months ago CAR-T

One Year After Approval: How Effective is China’s First BCMA-Targeted CAR-T Therapy in Treating Multiple Myeloma?

### One Year After Approval: How Effective is China’s First BCMA-Targeted CAR-T Therapy in Treating Multiple Myeloma?

Multiple Myeloma

“In the past 20 years, the treatment of multiple myeloma has advanced rapidly, thanks in large part to the swift progress in drug development. Over the past year, China’s first independently developed and the world’s first fully human BCMA-targeted chimeric antigen receptor T-cell (CAR-T) therapy was approved. In our real-world clinical applications, we have treated over 20 patients with an overall effectiveness rate of nearly 100%.”

On June 30, 2024, exactly one year after the approval of China’s first BCMA-targeted CAR-T therapy (Iquilonsen Injection), and also the world’s first fully human BCMA-targeted CAR-T therapy, how effective has the treatment been for patients? Professor Qiu Lugui, Director of the Lymphoma Treatment Center at the Chinese Academy of Medical Sciences Hematology Hospital, was interviewed by the People’s Daily Health Client.

“Multiple myeloma has a slow onset and early stages often show no obvious symptoms, making it easy to misdiagnose. To date, once diagnosed, the vast majority of patients experience one or more relapses, entering a refractory state, which is an incurable disease,” Professor Qiu Lugui told the People’s Daily Health Client.

Professor Qiu explained that current drugs for treating multiple myeloma fall into three categories: immunomodulators, proteasome inhibitors, and CD38 monoclonal antibodies. The indications for these drugs have gradually moved from refractory cases to frontline treatments, transforming multiple myeloma from a deadly disease with a median survival of around three years to a relatively controllable malignant hematological tumor with a median survival of 10 years or more after systematic multi-drug therapy.

CAR-T cell therapy is a cutting-edge technology for treating malignant hematological tumors. China’s independently developed fully human BCMA-targeted CAR-T drug (Iquilonsen Injection) is designed for multiple myeloma patients who have relapsed or whose disease remains uncontrolled despite traditional treatments including proteasome inhibitors and immunomodulators.

One particularly memorable case for Professor Qiu was a 70-year-old patient. “At that time, the patient was extremely weak and had already undergone all available treatments, including two types of immunomodulators, two types of proteasome inhibitors, CD38 monoclonal antibodies, and intensive chemotherapy, with no other effective options left,” recalled Professor Qiu. “However, the patient had a strong desire to live. Seeing his eager eyes, we couldn’t remain indifferent.”

“After confirming with the patient, we decided to proceed with the fully human BCMA-targeted CAR-T Iquilonsen therapy. One month after the treatment, the first evaluation showed complete remission. To date, the patient remains in complete remission,” said Professor Qiu.

“In real-world applications, we have treated over 20 patients with an overall effectiveness rate approaching 100%. However, due to the high cost of the drug and the fact that it is not covered by medical insurance, making the drug accessible remains a challenge,” Professor Qiu told the People’s Daily Health Client. “Currently, there are two methods to address this issue: one is to meet the needs of economically disadvantaged patients through commercial insurance; the other is to meet the needs of patients who meet the criteria for inclusion in CAR-T clinical research.”

“Additionally, in the year since the approval of China’s first CAR-T therapy for treating multiple myeloma, not only domestic patients but also patients from Europe, Asia-Pacific, Africa, and other regions have come to China for CAR-T treatment. Overall treatment driven by dynamic prognostic stratification will be the future path to cure for multiple myeloma patients both in China and globally,” said Professor Qiu.

#MultipleMyeloma #CARTTherapy #CancerTreatment #MedicalBreakthrough #BCMATargeted #ChinaHealthcare #InnovativeMedicine #PatientSuccess #GlobalHealth #Hematology #Immunotherapy

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4 months ago CAR-T

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

**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

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