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2 days ago Myeloma

Treatment for Multiple Myeloma: China’s BCMA×CD3 Bispecific Antibody Proposed for Breakthrough Therapy Designation

Multiple Myeloma

#MultipleMyeloma #BCMAxCD3 #BispecificAntibody #Immunotherapy #GR1803 #NMPA #RRMM

Recently, GR1803, an injectable solution developed by Genrix Bio, has been proposed for the “Breakthrough Therapy Designation” by the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA). This innovative drug targets relapsed and refractory multiple myeloma (RRMM), especially for patients who have undergone at least three lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

GR1803 is a novel bispecific antibody that simultaneously binds to BCMA and CD3 antigens. Its unique design allows for the effective activation of T-cells to attack tumor cells while minimizing non-specific T-cell activation, reducing potential side effects. In its Phase I clinical trial for RRMM, GR1803 demonstrated an overall objective response rate (ORR) of 85%, with an ORR of 100% in patients with extramedullary plasmacytoma (EMM).

The clinical performance of this product is remarkable, as evidenced by data presented at the 2024 European Hematology Association (EHA) annual meeting. As of January 2024, 40 trial participants have been enrolled, with an ORR of 85%. Notably, in the 180 ug/kg dose group, the median follow-up duration was 15 weeks, and 96% of the patients achieved a significant response.

What’s particularly noteworthy is the rapid response time; patients showed signs of improvement within a median of just 3 weeks. This suggests that GR1803 not only provides effective disease control in the short term but also continues to enhance patients’ conditions as treatment progresses.

The results from Genrix Bio’s research highlight that GR1803 offers new hope for RRMM patients, particularly for those who are unresponsive to conventional therapies. Its high response rate and favorable safety profile suggest that this drug could play a critical role in future cancer treatments.

The development of such groundbreaking drugs and the advancement of breakthrough therapies reflect China’s growing innovation in the global fight against cancer, offering new treatment options for patients 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

Https://wa.me/+8613717959070

Email: doctor.huang@globecancer.com

#MultipleMyeloma #CancerTreatment #BreakthroughTherapy #Immunotherapy #BiotechInnovation #GenrixBio #BCMAxCD3 #CancerResearch #OncologyNews #PharmaInnovation

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

3 weeks ago Myeloma

Redefining Hope for High-Risk RRMM Patients Worldwide: A Singaporean Patient`s Journey to China for Groundbreaking CAR-T Therapy

Multiple Myeloma

#MultipleMyeloma #CAR_Therapy #CancerTreatment #HRMM #MM #RRMM #CART

In the fight against multiple myeloma (MM), the last few decades have seen significant advancements, yet the disease remains notoriously difficult to cure, particularly in patients with relapsed/refractory multiple myeloma (RRMM). These patients face enormous challenges, as their options become increasingly limited after multiple lines of therapy have failed. However, hope has emerged in the form of BCMA CAR-T therapy, offering deep remission and long-term survival for those who had nearly lost hope.

One such case is a 58-year-old woman from Singapore, who after exhausting all available treatments in her home country, found new hope in China`s innovative CAR-T therapy. Diagnosed with MM in May 2021 following a month of severe back pain, she underwent a series of treatments including CD38 monoclonal antibodies, immunomodulatory drugs (IMiDs), proteasome inhibitors (PI), and XPO-1 inhibitors. Unfortunately, these therapies failed to halt the progression of her disease, which had become highly resistant to treatment.

In December 2023, she traveled to Beijing Chaoyang Hospital, Capital Medical University, where Professor Chen Wenming took charge of her case. The patient was diagnosed with high-risk MM (IgG-κ type) and admitted to the hospital on November 25, 2023, for CAR-T therapy.

#### The Treatment Journey: A Detailed Overview

Given the patient’s refractory nature and multiple prior treatments, Professor Chen devised a tailored treatment plan to improve her chances of survival and quality of life. In November 2023, her lymphocytes were collected to prepare the CAR-T cells. During this period, she received two cycles of D-PACE (dexamethasone, cisplatin, doxorubicin, cyclophosphamide, and etoposide) chemotherapy in Singapore to control the extramedullary plasmacytoma.

In February 2024, she returned to Beijing for further evaluation, where her condition was assessed as showing minimal response (MR). She was then administered a lymphodepletion regimen of fludarabine and cyclophosphamide on February 29. The following month, she received a transfusion of BCMA CAR-T cells.

Within five days post-transfusion, the patient developed a fever, which peaked at 39°C. Fortunately, her oxygen saturation and heart rate remained normal, and she was diagnosed with Grade 1 cytokine release syndrome (CRS). After symptomatic treatment, her blood counts recovered by day 15, and she was discharged in stable condition.

Two weeks post-CAR-T therapy, her response was evaluated as a very good partial response (VGPR), and by the two-month mark, her condition had improved to complete remission (CR) with minimal residual disease (MRD) negativity.

#### Insights from Leading Experts

Professor Wee Joo Chng, a specialist in high-risk MM, noted the aggressive nature of the patient’s disease, marked by genetic abnormalities like 1q21+ and t(4;14). Despite the use of multiple potent therapies, including KRd, XVd, and Isa-Pd, the patient’s disease continued to progress rapidly. The emergence of the del(17p) mutation further complicated her prognosis, indicating the need for a novel therapeutic approach.

The FUMANBA-1 study has highlighted the effectiveness of China`s indigenous CAR-T product, Equecabtagene Autoleucel, in achieving deep remission and prolonging survival in RRMM patients. This case demonstrated the therapy`s potential to overcome poor prognostic factors and extend the patient’s survival. Notably, the patient experienced only mild CRS and no immune effector cell-associated neurotoxicity syndrome (ICANS) or infections during treatment. At the two-month follow-up, the patient’s condition had improved to CR with MRD negativity, suggesting that Equecabtagene Autoleucel could be a game-changer for high-risk RRMM patients.

#### A New Frontier in CAR-T Therapy

RRMM patients with double-hit characteristics often experience early relapse and progression, leading to shortened survival times. Traditional therapies, including IMiDs, PIs, and monoclonal antibodies, have failed to overcome these poor prognostic factors, indicating the urgent need for novel treatments. Real-world studies have shown that CAR-T therapy offers comparable progression-free survival (PFS) and overall survival (OS) rates in RRMM patients, regardless of high-risk cytogenetic abnormalities.

The FUMANBA-1 study revealed impressive outcomes for Equecabtagene Autoleucel in RRMM patients, with an overall response rate (ORR) of 98.9% and an MRD negativity rate of 97.8% among CAR-T-naive patients. The CR rate was 82.4%, and 81.7% of patients maintained MRD negativity for over a year.

Globally, four CAR-T products are currently available, and a recent study presented at the 2024 European Society for Blood and Marrow Transplantation (EBMT) compared the short- and long-term efficacy of these therapies. The study’s matching-adjusted indirect comparison (MAIC) analysis revealed that Equecabtagene Autoleucel had a 12-month PFS rate of 94.2%, higher than the 75% observed with Ciltacabtagene autoleucel (CARTITUDE-1 study). Furthermore, the 12-month sustained MRD negativity rate for Equecabtagene Autoleucel was 100%, compared to 53.1% for Ciltacabtagene autoleucel.

These findings suggest that Equecabtagene Autoleucel, a Chinese-developed BCMA CAR-T therapy, offers superior long-term efficacy compared to its U.S. counterpart. As the global community celebrates the first anniversary of its approval, Equecabtagene Autoleucel continues to bring hope to RRMM patients worldwide, further solidifying China’s leading role in the field of cellular 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

#ChinaMedicalInnovation #GlobalHealth #MMResearch #PatientCare #InnovativeMedicine #CellTherapy #MedicalBreakthrough

1 month ago Myeloma

Overcoming Challenges and Embracing New Life! – Breakthrough Progress of Eque-cel in the Treatment of Refractory Multiple Myeloma

### Overcoming Challenges and Embracing New Life! – Breakthrough Progress of Eque-cel in the Treatment of Refractory Multiple Myeloma

Multiple Myeloma

In the treatment of multiple myeloma (MM), how do we find new breakthroughs for patients who have not achieved complete remission (CR) after multiple rounds of chemotherapy? Research by Chinese medical professors has provided an exciting answer: Eque-cel (BCMA CAR-T therapy).

Patient Background:

This 58-year-old female patient was initially admitted to the hospital due to numbness and pain in both lower limbs and was eventually diagnosed with multiple myeloma. Despite receiving various treatment regimens, including VRD and SVPD, the results were unsatisfactory, and complete remission was not achieved. Faced with refractory characteristics, the doctors decided to try a more innovative treatment plan—CAR-T cell therapy.

Treatment Process:

In September 2023, the patient began peripheral blood mononuclear cell collection, followed by bridging therapy, and in November 2023, she received the Eque-cel infusion. Remarkably, just one month later, the patient achieved hematologic complete remission (CR) with minimal residual disease (MRD) negativity. After six months of follow-up, the patient maintained this excellent therapeutic effect.

Professor’s Insights:

Chinese medical professors pointed out that the advent of Eque-cel has brought new hope to refractory MM patients. The drug demonstrated significant efficacy in the FUMANBA-1 study: the overall response rate was as high as 98.9%, with 82.4% achieving complete remission, and 97.8% of patients achieving MRD negativity. The 12-month sustained MRD negativity rate reached 81.7%, and the PFS rate was 85.5%.

This outstanding result proves the significant advantage of Eque-cel in improving the depth of remission for MM patients, bringing hope for long-term survival to many refractory patients.

Future Outlook:

As the application and research of Eque-cel continue, we look forward to it providing better treatment options and survival opportunities for more MM patients. This new treatment plan is bringing a ray of hope to this stubborn disease and providing valuable experience for clinical experts worldwide.

Stay Tuned:

We will continue to follow the latest developments and research progress of Eque-cel, looking forward to its greater role globally, bringing hope and blessings to more 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

#MultipleMyeloma #CARTTherapy #MedicalBreakthrough #EqueCel #CancerTreatment #MedicalResearch #Hematology #PatientCare #OncologyInnovation #HopeForPatients #BCMA #CART #MM #RRMM

1 month ago Myeloma

Chinese Medical Team: Long Survival and Significant Benefits with BCMA CAR-T Treatment for RRMM: A 5-Year Outlook

RRMM

Chimeric antigen receptor (CAR) T-cell therapy is one of the most promising new treatments for relapsed/refractory multiple myeloma (RRMM), but reports on its long-term efficacy and safety are limited. As early as 2022, Professor Du Juan’s team from the Department of Hematology at Shanghai Changzheng Hospital published a Phase I/II study demonstrating that patients with poor physical status could also benefit from CAR-T therapy. Recently, the team updated their findings with a five-year long-term follow-up, focusing on factors affecting long-term clinical benefits. The results were published in Clinical Cancer Research. The following summary of the study’s content is provided by Cancer Information for readers’ benefit.

### Evidence for Long-Term Efficacy and Safety of BCMA CAR-T Cell Therapy

#### Patient Characteristics

The study included 49 RRMM patients who had all received at least three prior lines of therapy before undergoing BCMA CAR-T cell treatment. At enrollment, 20 patients (40.82%) had poor physical status (ECOG performance status of 3-4), 42.86% had high-risk cytogenetic features, and 63.27% had received four or more lines of treatment. At the time of infusion, 79.59% had progressive disease. Among the patients with poor physical status, 30% had extramedullary disease (EMD), 45% had high-risk cytogenetic features, 70% had received four or more lines of treatment, and 80% had progressive disease after their last line of treatment.

#### Efficacy Evaluation of BCMA CAR-T Cell Therapy HDS269B

After a median follow-up of 59.0 months, the study showed an overall response rate (ORR) of 77.55%. The ORR was similar across patients with different ECOG scores. The median progression-free survival (PFS) was 9.5 months, and the median overall survival (OS) was 20.0 months. The five-year PFS and OS rates were 21.3% and 31.4%, respectively. For patients with ECOG scores of 0-2, the median PFS was 11.0 months, compared to 4.0 months for those with scores of 3-4 (P=0.18). The median OS was 41.8 months for ECOG 0-2 patients and 10.5 months for ECOG 3-4 patients (P=0.015).

Patients who had previously undergone four or more lines of therapy had significantly shorter PFS and OS compared to those who had received fewer than four lines (PFS: P=0.012; OS: P=0.0049). Among the 11 patients with EMD at enrollment, the ORR was 64% for those with EMD and 82% for those without EMD. However, median PFS and OS were notably shorter in patients with EMD (PFS: 3.0 months vs. 10.5 months, P=0.06; OS: 5.0 months vs. 24.0 months, P=0.03).

#### MRD-Negative Status and CAR-T Cell Persistence Indicate Better Long-Term Survival

Minimal residual disease (MRD) negativity was significantly associated with longer PFS and OS. In this study, MRD data were available for 22 patients on day 28 post-infusion, with 14 patients (63.64%) achieving MRD negativity (10^-4). These patients experienced significantly longer PFS and OS compared to MRD-positive patients. Similar associations were observed with MRD status at 3 and 6 months post-infusion.

The expansion of CAR-T cells was also closely related to clinical outcomes. Patients who achieved partial response (PR) or better had higher CAR-T cell peak levels. Patients without disease progression five years post-infusion had significantly higher CAR-T cell expansion peaks than those with progression. Additionally, the duration of CAR-T cell persistence correlated with longer PFS and OS, with patients having CAR-T cells persisting for ≥6 months, ≥12 months, ≥24 months, and ≥36 months showing significantly better PFS and OS than those without detectable CAR-T cells.

#### Controlled Safety Profile of BCMA CAR-T Cell Therapy HDS269B

No new CAR-T cell-related toxicities were observed during long-term follow-up. All patients experienced at least one adverse event (AE), with the most common long-term (≥28 days post-infusion) grade ≥3 AEs being hematologic in nature. No second primary malignancies or delayed immune effector cell-associated neurotoxicity syndrome (ICANS) were observed.

This study also included survival analysis, classifying patients by PFS and OS. The results indicated that ECOG 0-2 status, fewer than four prior therapies, and CAR-T cell persistence for ≥6 months were independently associated with longer survival.

### The Potential of BCMA CAR-T Therapy and the Need for Future Optimization

Through a five-year long-term follow-up of 49 RRMM patients, this study systematically evaluated the efficacy and safety of BCMA CAR-T cell therapy HDS269B. The findings suggest that poor physical status is not a contraindication for CAR-T therapy, thus broadening the indications for this treatment. While the results are encouraging, the study has some limitations, including its open-label, single-arm design and small sample size, which, combined with the long follow-up period, could lead to some patient attrition. Furthermore, despite the lack of new severe toxicities, long-term safety requires continued observation.

Overall, this study underscores the importance of BCMA CAR-T cell therapy in the treatment of RRMM and provides a crucial basis for exploring and applying CAR-T immunotherapy in the frontline treatment of multiple myeloma.

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

WhatsApp: +86137 1795 9070

Email: doctor.huang@globecancer.com

#CAR_Therapy #BCMACART #MultipleMyeloma #CancerResearch #LongTermSurvival #MedicalInnovation #Hematology #CancerTreatment #Immunotherapy #OncologyAdvances

2 months ago CAR-T

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

2 months ago Myeloma , CAR-T

What are the adverse reactions after CAR-T cell reinfusion?

Interpretation of Hot Topics Conerning Mutiple Myeloma Patients:

“What are the adverse reactions after CAR-T cell reinfusion?”

Process Diagram for Myeloma Patients Receiving CAR-T Therapy

RRMM(Relapsed/Refractory Multiple Myeloma)

Unveiling how the “million-dollar anti-cancer shot” saves patients with recurrent and refractory bone tumors! Taking you through the entire process of CAR-T therapy.

CAR-T细胞回输后有哪些不良反应?

骨髓瘤患者接受CAR-T治疗的流程图

权威专家解读之骨髓瘤全程管理

Expert Introduction

Jin Lu

Chief Phsician Professor Doctoral Supervisor

Peking University People’s Hospital,

Peking University Institute of Hematology

Director-General and Standing Committee of Hematolog Branch of Chinese Phsicians Association

Memer of the International Meloma oring Group Asia-Pacific Meloma oring Group

Associate Leader Plasma Ctolog Group Hematolog Branch Chinese Medical Association

Memer of the China and International Collaorative Group on Primar Sstemic Amloidosis

President of Hematologists Branch of Beiing Phsicians Association

Memer of International Research Group on Renal and Monoclonal lmmunogloulinopathies

Vice President of Hematolog Branch of Chinese Geriatrics Association and Chairman of Academic Commitee on Muliple Meloma

Associate Leader Multiple Meloma and Related Diseases Group Hematolog Committee Chinese Association of Female Phsicians

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 #Mutiplemyeloma #carttherapy #myeloma #leukemia #drug #RRMM #cancer #cancertreatment #tcell #cell #advancedmedical #AdvancedMedicineinChina

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

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

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

3 months ago Myeloma

Interpretation of Hot Topics Conerning Relapsed/Refractory Mutiple Myeloma Patients

Interpretation of Hot Topics Conerning Relapsed/Refractory Mutiple Myeloma Patients:

What other treatment options are available for patients with relapsed Multiple Myeloma?

How effective is the new drug treatment for the first relapse of Multiple Myeloma?

What treatment options are available for initial relapse of multiple myeloma?

What are the treatment goals for Relapsed/Refractory Multiple Myeloma (RRMM)?

What treatment strategy should be adopted for RRMM in order to achieve maximum relief?

For Relapsed/Refractory Multiple Myeloma, what are the Grades of Response?

Expert Introduction

👩‍🔬Zhuang Junling

Associate Chief Physician Department of Hematology

Peking Union Medical College Hospital

Published over 50 papers in journals such as Blood, Leukemia Research, and others.

🎉🎉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 #Mutiplemyeloma #CARTtherapy #myeloma #leukemia #drug #RRMM #cancer #cancersurvivor #cancerpatient #bloodcancer #tumor #cartcell #cartcelltherapy #cancertreatment #advancedmedicineinchina #hematology

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

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