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

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.

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3 months ago Solid tumor , CAR-T

**Chinese Biopharmaceuticals: Ushering in a New Era in Nasopharyngeal Carcinoma Treatment, EBV-Specific CAR-T Injection Approved for Phase II Clinical Trials in the US and China**

**Chinese Biopharmaceuticals: Ushering in a New Era in Nasopharyngeal Carcinoma Treatment, EBV-Specific CAR-T Injection Approved for Phase II Clinical Trials in the US and China**

Nasopharyngeal Carcinoma

#Nasopharyngeal #Carcinoma #BRG01 #CART #EBVspecific

Biosyngen has announced a milestone achievement: the company’s independently developed BRG01 injection (EBV-specific CAR-T) has received formal written approval from the U.S. Food and Drug Administration (FDA) to conduct pivotal Phase II clinical trials for the treatment of relapsed/metastatic EBV-positive nasopharyngeal carcinoma patients. This is the world’s first original cell drug for solid tumors approved in both the US and China to enter Phase II trials, bringing hope and breakthroughs to the field of solid tumor treatment.

Previously reported, the Center for Drug Evaluation (CDE) of the National Medical Products Administration has agreed to conduct pivotal Phase II clinical trials of BRG01 injection (EBV-specific CAR-T). Patients for the BRG01 US-China Phase I clinical trials completed enrollment by the end of January this year, and all trial participants have received BRG01 reinfusion treatment. The Phase I registered clinical trial of BRG01 has successfully completed DLT (dose-limiting toxicity) observation and efficacy evaluation in 9 patients, all of whom were advanced nasopharyngeal carcinoma patients who had failed at least one treatment, including PD-1 antibody immune checkpoint inhibitors.

The data shows that BRG01 has demonstrated excellent safety and preliminary efficacy: in PET-CT scans, 75% of high-dose patients experienced a local reduction in tumor lesions and a decrease in metabolic activity, with some patients achieving 100% complete remission of tumor lesions. Additionally, BRG01 also demonstrated excellent anti-EB virus efficacy, with a significant reduction of EB virus load in the peripheral blood of patients after reinfusion to normal levels.

These data not only highlight the potential of BRG01 in tumor treatment but also demonstrate its dual advantages in antiviral therapy, laying a solid foundation for future clinical applications. This is believed to be the key reason for the FDA’s approval of BRG01 to enter Phase II clinical trials.

The FDA’s approval not only highly recognizes the preliminary research results of BRG01 injection but also fully affirms Biosyngen’s innovative capabilities and research and development strength in the field of cellular immunotherapy. Biosyngen will take this as an opportunity to accelerate the clinical research process of BRG01 injection, striving to achieve the commercialization of this therapy as soon as possible to bring benefits to nasopharyngeal carcinoma patients worldwide.

Biosyngen’s layout in the field of solid tumor cell therapy goes far beyond this. The company has become a biotech enterprise with three major cellular therapies for both solid and hematological tumors: CAR-T, TCR-T, and TIL. The product pipelines have completed dual submissions and approvals in both the US and China, and the indications for the latter two include a variety of solid tumors such as lung and liver cancer.

Looking to the future, with Biosyngen’s efficient execution and rapid R&D achievements, we have reason to expect more clinical breakthroughs in solid tumor cell drugs in a shorter time, bringing new treatment hopes to 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

#Biosyngen #CAR_T #CancerTreatment #NasopharyngealCarcinoma #FDAApproval #ClinicalTrials #MedicalBreakthrough #BiotechInnovation #CancerResearch #Immunotherapy #HealthcareInnovation #CancerHope #SolidTumors #GlobalHealth #CancerCare

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3 months ago Solid tumor

**A Groundbreaking ADC Drug for Cervical Cancer Approved in China Macau**

**A Groundbreaking ADC Drug for Cervical Cancer Approved in China Macau**

Cervical Cancer

On August 6, 2024, Zai Lab proudly announced the approval of TIVDAK® (tisotumab vedotin-tftv) in Macau, marking the world’s first ADC (antibody-drug conjugate) specifically for cervical cancer. This innovative treatment is intended for patients with recurrent or metastatic cervical cancer who have experienced disease progression during or after chemotherapy.

TIVDAK stands as a significant milestone, being the first ADC drug approved by the FDA for cervical cancer. Following its accelerated approval in 2021, the FDA granted full approval in April 2024, solidifying its use for patients needing treatment after chemotherapy failure.

The FDA’s full approval was backed by positive outcomes from the global Phase 3 clinical trial, innovaTV 301. This study demonstrated that patients treated with TIVDAK experienced an overall survival benefit compared to those receiving chemotherapy. This finding is particularly noteworthy, as TIVDAK is the first ADC drug globally to show clear survival benefits for patients with second and third-line metastatic or recurrent cervical cancer.

Cervical cancer remains a leading threat in women’s health. Despite advancements in prevention through vaccination and early diagnosis via screening, there remains a significant unmet need for effective treatments. In China alone, an estimated 150,000 new cases are diagnosed each year, with approximately 60,000 fatalities. At the time of diagnosis, around 15% of adult patients have metastatic disease. For those diagnosed early and receiving treatment, up to 61% experience recurrence.

Zai Lab is participating in the global innovaTV 301 study and anticipates submitting a marketing application in China by early 2025. This approval in Macau represents a significant step forward in providing new hope for cervical cancer 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

#CervicalCancer #ADCDrug #TIVDAK #ZaiLab #CancerTreatment #WomenHealth #MedicalAdvancement #FDAApproval #ClinicalTrial #Macau #GlobalHealth #InnovativeTherapy #PatientCare #Pharmaceuticals

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