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)**

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.

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.

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.

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).

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.

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.

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.

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

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4 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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4 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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4 months ago Solid tumor

Hope to Eradicate Lung Cancer, Colorectal Cancer, and Various Solid Tumors! China’s First Self-Replicating mRNA Vaccine JCXH-211 Successfully Launched~

Hope to Eradicate Lung Cancer, Colorectal Cancer, and Various Solid Tumors! China’s First Self-Replicating mRNA Vaccine JCXH-211 Successfully Launched~

mRNA Vaccine

Tumor immunotherapy, as an emerging method for diagnosing and treating tumors, has garnered widespread attention since its inception. Prior to the advent of tumor immunotherapy, the clinical treatment of solid tumors relied solely on traditional surgical removal, radiotherapy, and chemotherapy. Although these methods were effective, they came with significant drawbacks such as drug side effects and the risk of recurrence.

Since the 1990s, mRNA vaccines have been considered therapeutic vaccines. During the COVID-19 pandemic in 2020, mRNA vaccines were used in clinical treatments, saving countless lives. Today, as the advantages of mRNA vaccines are gradually being discovered, they are now applied in multiple fields.

The advent of China’s first self-replicating mRNA vaccine JCXH-211 undoubtedly marks a new breakthrough in the clinical diagnosis and treatment of various solid tumors in China.

**What is the mRNA Vaccine JCXH-211?**

JCXH-211 is the world’s first self-replicating RNA drug encoding human interleukin-12 (IL-12) to enter clinical trials. This srRNA vaccine delivers mRNA encoding IL-12 into the cytoplasm, continuously expressing IL-12 to enhance the body’s immune response against tumor cells.

In preclinical studies involving various mouse and PDX disease models, JCXH-211 has shown the ability to effectively kill tumor cells, eliminate distant tumors, and prevent tumor recurrence. Comprehensive GLP toxicology studies have also demonstrated good safety.

JCXH-211 has a broad range of indications and is expected to effectively treat multiple solid tumors. The anticipated prospects are as follows:

**1. Lung Cancer:**

As one of the leading causes of cancer death worldwide, lung cancer is often diagnosed at a late stage due to difficulties in early detection. JCXH-211, through continuous expression of IL-12 and activation of immune cells, is expected to effectively control the growth and spread of lung cancer cells.

**2. Colorectal Cancer:**

Current clinical treatments for colorectal cancer primarily involve surgery and radiotherapy/chemotherapy, which can remove visible tumors but have a high recurrence rate. Periodic administration of JCXH-211 may significantly reduce recurrence and improve patient survival.

**3. Soft Tissue/Chondrosarcoma:**

These tumors are highly invasive and cover a wide range of areas, often affecting surrounding soft tissues and progressing rapidly. Current treatments are limited to surgery and radiotherapy/chemotherapy, which, although somewhat effective, are not thorough, leading to high recurrence rates. JCXH-211 could become a new treatment method, enhancing the body’s immune response to combat these stubborn cancer cells.

**4. Skin Cancer:**

Clinical treatments for skin cancer mainly include surgery and radiotherapy. While most skin cancers have a good prognosis, the effects on intractable melanoma are poor. The expression of IL-12 can activate specific T cells, greatly aiding in the elimination of melanoma cells.

**High-Efficiency Activation and Safety of the mRNA Vaccine JCXH-211!**

mRNA vaccines not only encode antigens to induce specific immune responses against tumors but also possess inherent immunostimulatory properties. This dual mechanism allows JCXH-211 to activate the immune system more efficiently, enhancing the overall anti-tumor effect.

Moreover, the safety of mRNA vaccines is well-recognized. Since DNA is the genetic material of most species, including humans and viruses, and is transcribed into mRNA before being translated into proteins to perform functions in the body, injecting mRNA into the human body does not enter the cell nucleus, thereby eliminating the risk of genomic insertion mutations. Additionally, mRNA can be naturally degraded and excreted from the body, preventing accumulation. Thus, JCXH-211 presents lower potential risks and is safer.

Currently, clinical trials are progressing steadily. With the rapid advancement of tumor immunotherapy, JCXH-211 is expected to become a standard treatment for various solid tumors, offering hope to many cancer patients.

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

WhatsApp: +8613717959070

Email: doctor.huang@globecancer.com

#LungCancer #ColorectalCancer #SolidTumors #mRNAVaccine #JCXH211 #CancerTreatment #TumorImmunotherapy #MedicalBreakthrough #Biopharma #CancerResearch #HealthcareInnovation #CancerHope #MedicalScience #HealthTech #ClinicalTrials #CancerSurvivor #CancerAwareness #InnovativeMedicine #CancerVaccine #Vaccine #mRNA #JCXH

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5 months ago Solid tumor

Tumors Vanish After One Year of Treatment! The First Advanced Gastric Cancer Patient to Receive the New Cancer Vaccine Achieves Lasting Remission

**Tumors Vanish After One Year of Treatment! The First Advanced #GastricCancer Patient to Receive the New #Cancer Vaccine Achieves Lasting Remission**

Cancer Vaccine

Mrs. Liu, who was battling advanced gastric cancer, never imagined that one year ago, she was on the brink of death due to chemotherapy, with her disease progressing rapidly and cancer spreading throughout her body… Later, she won the “lottery” of her life. She received one of the world’s most advanced immunotherapies—cancer vaccines—in Fujian. One year later, all her cancer lesions have completely disappeared! Her successful case was even published in a prominent international journal, a Nature sub-journal, causing a huge sensation.

**First Advanced Gastric Cancer Patient to Receive the New Cancer Vaccine Achieves Lasting Remission! Tumors Vanish After One Year of Treatment**

In July 2017, 66-year-old Mrs. Liu was unfortunately diagnosed with stage IV gastric cancer. After surgery, she underwent FOLFOX chemotherapy to eliminate residual cancer cells, and everything seemed to be going well. Unfortunately, just eight months later, Mrs. Liu’s cancer recurred, and multiple lesions were found not only in her stomach but also in her peritoneum and lymph nodes, indicating that the cancer had rapidly spread throughout her body. Mrs. Liu had to undergo chemotherapy again. However, this time, her body could no longer withstand the side effects. After two cycles of Nab-paclitaxel, she was on the brink of death due to severe side effects and had to stop chemotherapy.

When she and her family were in despair, the doctors brought them good news. A nationally renowned cancer center was conducting a clinical trial of a cancer vaccine. Remarkably, this new type of cancer vaccine was a hot topic of research worldwide and had achieved significant breakthroughs.

The new cancer vaccine is a personalized, neoantigen-loaded monocyte-derived dendritic cell vaccine, known as Neo-MoDC. This vaccine fully mobilizes the immune system: dendritic cells (DCs) recognize cancer antigens, present antigens to activate T cells, promote T cell enrichment, and mobilize T cells to eliminate cancer cells, ultimately launching a series of precise and powerful attacks on cancer cells throughout the body.

Mrs. Liu decided to participate in the clinical trial of this new therapy.

This new therapy is actually much more complex than described above. Doctors first performed whole-exome sequencing on her tumor tissue samples, identifying 1,096 somatic non-synonymous mutations. They then determined her HLA (human leukocyte antigen) types as HLA-A02:07, HLA-A24:02, HLA-B40:01, HLA-B46:01, HLA-C01:02, and HLA-C03:04. Based on the binding affinity of these predicted mutant peptides with the patient’s HLA I class alleles, eight soluble mutant epitopes with the highest affinity were identified to prepare a personalized neoantigen dendritic cell cancer vaccine specifically targeting her cancer cells.

Mrs. Liu successfully received two months of subcutaneous Neo-MoDC vaccine injections to activate the T cell anti-tumor immune response. Researchers confirmed that the Neo-MoDC vaccine successfully induced a neoantigen-specific T cell response. For better therapeutic results, from day 65, Mrs. Liu received nivolumab (PD-1) treatment every 14 days.

An unexpected surprise occurred.

Five days later, Mrs. Liu’s CA-125 level rapidly dropped from 596 to 64 U/ml;

Two weeks later, malignant ascites disappeared, and clinical imaging showed a 30% reduction in the volume of metastatic supraclavicular lymph nodes;

Two months later, all metastatic lymph nodes reduced to less than 1 cm, and evaluations showed complete remission (CR) in the lymph nodes, with a 20% reduction in the longest diameter of ovarian metastatic lesions.

On the 231st day after the initial vaccination, imaging showed complete regression of all lesions;

On the 389th day of combined treatment, a CT scan showed that the ovarian metastatic lesions had also completely disappeared;

Subsequent CT scans confirmed that by the time of the paper’s publication (October 2021), complete regression had lasted for over 25 months.

This result indicates that the neoantigen vaccine Neo-MoDC and PD-1 in combination therapy may enhance each other’s efficacy, achieving better treatment outcomes, and providing a new immunotherapy combination for metastatic gastric cancer and other tumor types.

Mrs. Liu said that after the failure of chemotherapy, she was in despair, counting down the days of her life. She couldn’t imagine that she would have the opportunity to receive such cutting-edge therapy in China, let alone believe that she would become the fortunate one in this milestone research, successfully defeating cancer and returning to normal life!

In June 2022, this study was published in a prominent international journal, a Nature sub-journal, marking the first known case of complete and lasting tumor regression in gastric cancer through neoantigen-based DC vaccine and PD-1 therapy, which is of milestone significance!

**Cancer Vaccines Will Ultimately Become a Sword Against Cancer!**

Throughout the long history of humanity, various vaccines have been developed to combat devastating diseases, leading to the eradication of deadly diseases like smallpox and poliomyelitis. Similarly, the medical community is actively developing various vaccines to fight cancer, hoping to awaken our immune system to recognize and kill cancer cells upon injection, and to generate immune memory responses that protect us continuously, attacking any emerging cancer cells before they form tumors. This vision will eventually become a reality!

Immunotherapy is hailed as the hope for conquering cancer. Whether it’s the currently approved PD-1 immune checkpoint inhibitor therapy for various cancers, adoptive cell immunotherapy represented by CAR-T, or numerous cancer vaccines under development, they represent just the tip of the iceberg in immunology. Researchers are uncovering more information from this iceberg, learning how to control immune responses, and using these therapeutic approaches in clinical practice to benefit patients, giving us increasing hope for survival. The hope for conquering cancer may lie within these advances. We look forward to more breakthroughs in immunotherapy, bringing more miracles to cancer patients.

To assess whether the condition is suitable for New Cancer Vaccine or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!

WhatsApp: 137 1795 9070

Email: doctor.huang@globecancer.com

#CancerVaccine #StomachCancer #Immunotherapy #CancerResearch #MedicalBreakthrough #CancerTreatment #HealthcareInnovation #PatientSuccess #Oncology #MedicalAdvancements

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5 months ago Solid tumor

Breakthrough in mRNA Cancer Vaccine! Chinese Medical Team Brings New Hope to Advanced Cancer Patients Resistant to Traditional Treatments

Breakthrough in mRNA Cancer Vaccine! Chinese Medical Team Brings New Hope to Advanced Cancer Patients Resistant to Traditional Treatments

Cancer Vaccine

The rise of mRNA vaccines during the COVID-19 pandemic has inspired their use in cancer treatment. Recently, Professor Shen Baiyong’s team at Ruijin Hospital published a groundbreaking study in *Cell Research*. They reported the first therapeutic effects of an mRNA cancer vaccine targeting the KRAS G12V mutation in solid tumors globally, offering new hope to advanced cancer patients resistant to traditional treatments.

#### Research Highlights

Two patients with the KRAS G12V mutation and HLA-A*11:01 positivity were treated with the KRAS G12V mRNA vaccine and PD-1 inhibitors.

– **First Case**: An 86-year-old woman with pancreatic cancer showed significant lesion reduction and improved quality of life after treatment.

– **Second Case**: A 69-year-old man with advanced lung cancer experienced partial tumor regression and no notable side effects after treatment.

#### Significance

This study highlights the efficacy of mRNA cancer vaccines in treating advanced solid tumors. The KRAS G12V mutation has strong binding affinity with HLA-A11:01, common in Asians, suggesting many could benefit from this therapy.

Professor Shen, who leads the Pancreatic Disease Treatment Center at Ruijin Hospital, focuses on comprehensive pancreatic cancer care and has initiated clinical trials on mRNA vaccines for advanced patients.

#### Clinical Trials

Ruijin Hospital is conducting trials on fixed single-target, multi-target personalized, and postoperative preventive mRNA vaccines, promising new hope for patients. For more information, please contact us.

This innovative research could bring new treatment options to more 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

Email: doctor.huang@globecancer.com

#CancerResearch #mRNAVaccine #MedicalBreakthrough #AdvancedCancer #InnovativeTreatment #Healthcare #Oncology #ChineseMedicalTeam #NewHope #CancerTreatment #CellResearch

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5 months ago CAR-T

**2024 ASCO: National Institute’s New CAR-T Therapy CD7 CAR-T Cells, Multiple Blood Cancer Destroyers**

**2024 ASCO: National Institute’s New CAR-T Therapy CD7 CAR-T Cells, Multiple Blood Cancer Destroyers**

CAR-T Therapy

**2024 ASCO: Four Chinese-developed CAR-T therapies make a significant impact, targeting colorectal cancer, pancreatic cancer, and hematological tumors, with an overall response rate nearing 100.0%**

 

**CD7 CAR-T Cells: A Powerful Strike Against Hematological Tumors, Patients Achieve Complete Remission**

 

Patients with relapsed or refractory hematologic malignancies have limited treatment options and poor prognosis, with a 5-year overall survival rate of less than 20%. While allogeneic hematopoietic stem cell transplantation (HSCT) provides a critical strategy for treating aggressive hematologic cancers, HSCT treatment can also result in adverse reactions such as graft-versus-host disease (GVHD) and conditioning-related toxicities. Additionally, some patients with poor health cannot undergo this treatment. Therefore, new treatment methods are urgently needed, and the emergence of CAR-T therapy has brought new hope to patients with hematologic tumors.

 

The world-renowned journal, *The New England Journal of Medicine*, reported on a clinical study of “CD7 CAR-T cells for the treatment of relapsed or refractory CD7-positive hematologic tumors” (NCT04599556).

 

From November 2021 to September 2023, 10 patients with relapsed or refractory CD7-positive cancers were enrolled in the study, including 7 cases of acute myeloid leukemia (AML), 2 cases of T-cell acute lymphoblastic leukemia (ALL), and 1 case of T-cell lymphoblastic lymphoma (IVA stage). The median age was 56.5 years (range, 13.7–72.5 years). All patients had bone marrow involvement, with a median blast cell percentage of 36.0% (range, 2–87), and a median CD7 expression on blast cells of 93.0% (range, 80.7–97.7). All patients had received extensive prior treatments, with a median of 9.5 courses (range, 4–15 courses). After enrollment, patients first received an intensive lymphocyte-depleting regimen (cyclophosphamide, fludarabine, etoposide) and then CD7 CAR-T cell infusion therapy. After a median follow-up of 15.1 months, the results showed:

 

1. **Complete Remission (CR):** All patients (n=10) achieved complete remission (CR) after CAR-T cell therapy, though hematologic recovery was incomplete, with grade 4 pancytopenia. As of November 8, 2023 (data cutoff date), 6 patients had not received any further treatment and remained in minimal residual disease (MRD) negative complete remission.

 

2. **Overall Survival Rate:** The estimated 1-year overall survival rate was 68% [95% Confidence Interval (CI), 43–100].

 

3. **Disease-Free Survival Rate:** The estimated 1-year disease-free survival rate was 54% (95% CI, 29–100).

🎉🎉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

 

#ASCO2024 #CARTherapy #BloodCancer #CD7CART #CancerResearch #Hematology #MedicalInnovation #CART

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7 months ago patient story

Hope Rekindled: The Remarkable Journey of a Pakistani Multiple Myeloma Patient in China

Hope Rekindled: The Remarkable Journey of a Pakistani Multiple Myeloma Patient in China

Hope of patient

“When I first arrived, I couldn’t walk and had a lot of pain in my chest and back. Now, I don’t have these symptoms anymore, and I can walk for more than ten minutes every day.”

Meet Julian, a patient from Pakistan who faced the daunting challenge of a relapse in his battle against Multiple Myeloma. Despite undergoing various treatments, relief seemed elusive.

Julian’s wife stumbled upon groundbreaking research published by Xuzhou Medical University, highlighting innovative cell therapy for Multiple Myeloma developed by the Tumor Biotherapy Research Institute and affiliated hospitals.

Seeking further treatment, Julian and his wife embarked on a journey to Xuzhou Medical University Affiliated Hospital. Upon arrival, thorough examinations were conducted to assess his condition and formulate a tailored treatment plan.

Julian underwent T-cell collection at the Hematology Department’s Cell Collection Room, with the harvested cells processed into CAR-T cells by Xuzhou Medical University’s Cancer Research Institute. Two weeks later, he received an infusion of immune cells (CD19CAR-T cells, BCMACAR-T cells).

A month later, bone marrow cytology revealed complete remission of the primary disease. His attending physician continued medical observations, confirming positive treatment outcomes through comprehensive examinations.

“Previously, I couldn’t sit like this, and walking was very difficult. It was also very uncomfortable to lie down.”

”After receiving CAR-T treatment, you can see that I can now sit normally, walk normally, and my mobility is gradually increasing.

My improvement is very significant.”

From treatment initiation to Julian’s discharge and return home, the entire process took just one and a half months.

Julian’s journey stands as a beacon of hope, showcasing the transformative potential of innovative medical interventions in the fight against 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: +8613717959070

Email: doctor.huang@globecancer.com

#MiracleTreatment #CancerResearch #MedicalInnovation #Hopeofpatient #patientstory #XuzhouMedicalUniversity #MultipleMyelomaAwareness #MultipleMyeloma #Chinesemedical

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7 months ago CAR-T

2024 AACR | China’s Innovative Medicine Leads Globally! Dazzling International with Multi-Cancer Research Achievements

2024 AACR | China’s Innovative Medicine Leads Globally! Dazzling International with Multi-Cancer Research Achievements

AACR2024

#AACR

This month, the annual cancer research summit, #AACR, arrived in San Diego, USA! Focused on #tumor research and innovation, top global achievements were fully showcased. Under China’s Biopharmaceuticals, the new drug, Anlotinib from Zhongda Tianqing, shines brightly!

Latest Research Progress

ALTER-G-001, a diversified and cross-regional Phase II study, unveiled the latest results of Cohort C. Patients receiving Anlotinib + standard chemotherapy for 6 cycles showed remarkable efficacy. Anlotinib combined with chemotherapy, especially demonstrated significant effects in pancreatic cancer patients!

Key Data

Enrolled 41 patients, covering various cancer types including pancreatic, #gastric, #biliarytract, and #duodenal cancer,

ORR reached 42.3% in #pancreaticcancer patients

DCR soared to 88.5%

Median PFS reached 5.8 months

After efficacy assessment, tumors in 14 SD patients showed shrinkage

Treatment Outlook

Research results indicate that Anlotinib combined with chemotherapy as first-line treatment, particularly for digestive tract tumors with unresectable liver metastases, especially in pancreatic cancer patients, has significant efficacy. This may open up a completely new treatment path for such patients, bringing new hope!

Embark on an exploration of life from here!

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

#AACR2024 #OncologyResearch #InnovativeMedicine #cancerreseach #cart

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7 months ago CAR-T

AACR 2024/Breakthrough Chinese Research – Monotherapy for Late-stage #SolidTumors and #Lymphomas

AACR 2024/Breakthrough Chinese Research – Monotherapy for Late-stage #SolidTumors and #Lymphomas

AACR2024

#AACR2024

At the 2024 American Association for Cancer Research (#AACR) Annual Meeting, innovative drugs from China showed promising safety and preliminary efficacy in early clinical trials, attracting high interest from attending experts and researchers, showcasing the strength of #Chineseresearch teams in new drug development.

#TQB2916

A groundbreaking focus of cancer research is on #TQB2916, the latest #CD40 agonist antibody causing a stir in the medical field.

#CD40

 receptors, a member of the tumor necrosis factor receptor family, play a vital role in immune responses. TQB2916, a humanized IgG2 CD40 monoclonal antibody, has demonstrated CD40 activation and promising anti-tumor activity in preclinical studies. With its potential to revolutionize cancer treatment, TQB2916 is currently undergoing its first human study for late-stage solid tumors and lymphomas, led by the team at Tianjin Medical University Cancer Institute & Hospital.

#ECOG

Now, let’s delve into the details: Eligible patients, including those with an ECOG performance status of 0 or 1, adequate hematologic and organ function, and no response to standard treatments, are enrolled. TQB2916 is administered intravenously every 3 weeks until disease progression or unacceptable toxicity. The study utilizes a Bayesian Optimal Interval (BOIN) design to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TQB2916.

#Realcase

From April 2022 to November 2023, a total of 18 patients with solid tumors and 2 with lymphomas underwent TQB2916 monotherapy and were assigned to 7 dose cohorts. Adverse events were observed, with the most common including lipase increase, amylase increase, lymphocyte count decrease, ALT increase, ALP elevation, AST elevation, hypoalbuminemia, and anorexia. However, most adverse events were manageable, primarily Grade 1 or 2 severity.

#Lymphomas

Of the 16 evaluated patients, 3 achieved stable disease according to immune RECIST criteria for solid tumors and LYRIC criteria for lymphomas. Pharmacokinetic analyses showed favorable performance, with no drug accumulation upon repeat dosing. Additionally, dose-dependent occupancy of CD40 receptors was detected, alongside peripheral B cell reduction and increased cytokine secretion.

#Conclusion

TQB2916 achieves CD40 engagement and immune activation through cytokine modulation. With its promising safety and efficacy profile, 200mg has been identified as the preliminary expansion dose. Studies exploring TQB2916 in combination with immune checkpoint inhibitors and/or other anti-cancer therapies are currently underway.

Stay tuned for more updates on this groundbreaking treatment!

You can send electronic copies or photos of genetic testing reports and diagnostic reports to the email address:

doctor.huang@globecancer.com

WhatsApp +86137 1795 9070

The Medical Department will contact you as soon as they receive the reports.

#CancerResearch #Immunotherapy #MedicalBreakthrough #AACR22024 #chinesemedical

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7 months ago CAR-T

AACR 2024/Breakthrough in Treating Recurrent or Metastatic Nasopharyngeal Carcinoma by Chinese Medical Team

AACR 2024/Breakthrough in Treating Recurrent or Metastatic Nasopharyngeal Carcinoma by Chinese Medical Team

AACR 2024

We’re thrilled to share groundbreaking updates from the 2024 American Association for Cancer Research (AACR) Annual Meeting!

China’s innovative pharmaceuticals are making waves in early clinical trials, hinting at promising breakthroughs in cancer treatment!

At the forefront is the remarkable research on Treprilimumab, a monoclonal antibody, showcased by Prof. Ma Haiqiang and his team from Sun Yat-sen University Cancer Center.

Their pioneering work focuses on advancing treatments for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC), a challenging form of cancer.

Treprilimumab, administered subcutaneously, has shown remarkable safety and preliminary efficacy when combined with Gemcitabine and Cisplatin (GP), earning FDA approval in October 2023 for first-line therapy in RM-NPC.

The team initiated the first human clinical trial to assess Treprilimumab’s pharmacokinetics in RM-NPC, aiming to establish optimal subcutaneous dosing regimens for future trials.

The study enrolled RM-NPC patients, confirmed histologically, and previously untreated systemically. Patients received Treprilimumab SC at 240mg Q3W, 360mg Q3W, or 480mg Q6W, in combination with GP for up to 6 cycles, followed by Treprilimumab SC monotherapy until disease progression, intolerable toxicity, or completion of 2 years of treatment. Tumor response was assessed by RECISTv1.1 criteria, with primary endpoints focusing on pharmacokinetics and secondary endpoints including safety, efficacy, and immunogenicity.

From November 24, 2022, to November 20, 2023, 38 patients were enrolled, with a median follow-up of 6.8 months. The median age was 49, with 73.7% male. Pharmacokinetic analysis revealed comparable exposure between Treprilimumab 360mg Q3W SC and 240mg Q3W IV in the first cycle. Overall response rates (ORR) were 100%, 92.3%, and 92.3% for the 240mg, 360mg, and 480mg groups, respectively. By November 20, 2023, 71.1% of patients experienced sustained remission, with no new safety concerns. Grade ≥3 adverse events (AEs) occurred in 76.3% of patients, with no fatalities. Immune-related AEs were reported in 36.8% of patients, with one case of grade ≥3.

These groundbreaking findings demonstrate comparable safety and clinical efficacy between Treprilimumab SC and IV formulations when combined with GP in treating RM-NPC patients. The exposure of Treprilimumab 360mg Q3W SC mirrors that of 240mg Q3W IV. Excitingly, Treprilimumab SC formulations are slated for Phase III clinical development, promising hope for enhanced cancer therapies!

Stay tuned for more updates on this game-changing research!

To assess whether the condition is suitable for Chinese Top level therapy, you can submit pathology reports, treatment history, and discharge summaries to the Medical Department of <Advanced Medicine in China> for preliminary evaluation!

WhatsApp: 137 1795 9070

Email: doctor.huang@globecancer.com

#AACR2024 #CancerResearch #InnovationInMedicine

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