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*For reference only for medical professionals, MRG002, as a new generation ADC drug, has a unique design and innovative mechanism, and has excellent performance in the treatment of advanced HER2-positive urothelial carcinoma
.
Urothelial cancer is a multi-source malignant tumor originating from urothelial cells, including bladder cancer, ureter cancer, and renal pelvis cancer.
It is the most common urinary system tumor, accounting for about 90.
0% of all bladder cancers, accounting for adults 10.
0%-15.
0% of kidney cancer, and the HER2 positive rate of urothelial cancer is about 36.
0%
.
The platinum-containing regimen is an effective first-line treatment regimen for patients with advanced urothelial cancer, but after a period of time, patients are prone to drug resistance to chemotherapy, leading to tumor recurrence and progression
.
At present, PD-1/PD-L1 immunotherapy is the second-line recommendation for second-line treatment in China, but the overall remission rate is only about 20%, and the first-level recommendation is still to participate in clinical research
.
Moreover, patients are prone to local and systemic complications during treatment
.
Local complications include chemical cystitis, which can lead to lower urinary tract symptoms such as urgency, frequent urination, pain, or hematuria
.
Systemic complications can lead to systemic symptoms such as bone marrow suppression and renal insufficiency
.
In general, the current second-line treatment of advanced metastatic urothelial carcinoma still lacks effective means
.
The clinical information registration platform for advanced metastatic urothelial cancer is mainly the clinical research of PD-1/PD-L1 products
.
Among them, an open, single-arm, multi-center phase II clinical trial of MRG002 for the treatment of HER2-positive unresectable locally advanced or metastatic urothelial carcinoma after at least first-line systemic chemotherapy was launched in February 2021
.
A subject admitted by Prof.
Han Weiqing’s team from Hunan Cancer Hospital, treated with MRG002 for only 6 weeks, the bladder mass disappeared (14.
2mm to 0mm), the retroperitoneal lymph nodes were greatly reduced (15.
5mm to 6.
5mm), and the total diameter of the target lesion Compared with the baseline, it is significantly reduced by nearly 78% (29.
3mm to 6.
5mm), and the effect is surprising
.
Brief introduction of medical records and trial enrollment The patient was a male who was diagnosed with urothelial carcinoma in September 2019.
After various treatment options such as surgery, chemotherapy and immunotherapy, the disease continued to progress and metastasize (Table 1)
.
Table 1.
After the summary of the previous diagnosis and treatment, the patients were enrolled in MRG002 to treat HER2-positive unresectable locally advanced or metastatic urothelial carcinoma after at least first-line systemic chemotherapy.
Open, single-arm, multi-center phase II clinical trial, accepting MRG002 Single-drug therapy, after 2 cycles of treatment, all non-target lesions disappeared, one target lesion disappeared, and the retroperitoneal lymph node of the other target lesion shrank to 6.
5 mm.
See the following figure for details: Figure 1.
Baseline of bladder mass (left) and first medication Bladder mass after 6 weeks (right) Figure 2.
Retroperitoneal lymph node baseline (left) and retroperitoneal lymph node 6 weeks after the first medication (right) Case review At present, platinum-based combination chemotherapy is recurrent and metastatic urinary tract The basic treatment for skin cancer, but the survival benefit of patients is limited
.
For treatment options after chemotherapy is invalid, immunotherapy and ADC are currently the most concerned
.
Before MRG002 treatment, this patient had been treated with chemotherapy and immunotherapy for up to six months, but the target lesions continued to increase
.
In the case of receiving MRG002 treatment for only 6 weeks, both the target and non-target lesions were significantly reduced, and the efficacy assessment reached a complete remission (CR), which is expected to translate into a longer survival benefit for patients, indicating that MRG002 treatment is local The preliminary curative effect of advanced or metastatic urothelial carcinoma, and suggests that MRG002 still performs well for HER2-positive advanced urothelial carcinoma that is ineffective in chemotherapy combined with immunotherapy
.
MRG002 can achieve such obvious curative effect is closely related to its unique structure and innovative mechanism of action.
MRG002 is currently a promising ADC drug in the field of tumors [the sugar-modified trastuzumab can be cleaved through the vc linker and auristatin E (MMAE) conjugated], through the unique design and innovative improvement of trastuzumab, it can improve the safety and tolerability of patients while ensuring the enhancement of anti-tumor efficacy
.
With the high affinity of trastuzumab, it specifically binds to the HER2 antigen on the surface of tumor cells, internalizes and releases the cytotoxic payload MMAE, effectively inhibits tubulin polymerization, thereby interfering with microtubule-related functions (such as mitosis), resulting in Tumor cells die
.
In addition, the innovative modified trastuzumab has a selective higher fucosylation level in the Fc region, resulting in reduced binding of Fc to effector immune cells, so as to minimize the potential killing of immune cells by MRG002, thereby reducing the risk to patients Potential adverse immune related effects
.
At present, no drugs for the treatment of HER2-positive urothelial cancer have been approved for marketing at home and abroad, and the HER2 positive rate of urothelial cancer is about 36.
0%, which shows that the development of urothelial cancer treatment drugs with HER2 as the target is very important.
The direction of potential exploration
.
MRG002 is a new-generation ADC drug targeting HER2, which combines the advantages of monoclonal antibody targeting, strong selectivity and high anti-tumor activity of cytotoxic drugs, and is more optimized in chemical design, compared with the targeted targeting on the market.
HER2 ADC drugs have shown certain competitive advantages in the field of solid tumor treatment
.
It is hoped that in the field of HER2-positive urothelial cancer treatment, MRG002 can continue to make progress, bring more excellent performance, and fill the treatment gap in this clinical field as soon as possible
.
At present, it is sponsored by Shanghai Miac Biotechnology Co.
, Ltd.
, a subsidiary of Lepu Biotech, and led by Professor Zhou Aiping from the Cancer Hospital of the Chinese Academy of Medical Sciences and Professor Zhou Fangjian from the Cancer Center of Sun Yat-sen University.
The open, single-arm, multi-center phase II clinical trial of locally advanced or metastatic urothelial cancer" was carried out in more than 20 centers across the country.
The selected patients can receive free ADC drug treatment.
"HER2-positive patients who are diagnosed as unable to Patients with locally advanced or metastatic urothelial carcinoma undergoing surgical resection are welcome to consult
.
If you are interested in this clinical research, you can contact 021-61637960; you can also check the outpatient time of each researcher on the Internet for consultation: *This article is only used to provide scientific information to medical professionals, and does not represent the views of this platform
.
Urothelial cancer is a multi-source malignant tumor originating from urothelial cells, including bladder cancer, ureter cancer, and renal pelvis cancer.
It is the most common urinary system tumor, accounting for about 90.
0% of all bladder cancers, accounting for adults 10.
0%-15.
0% of kidney cancer, and the HER2 positive rate of urothelial cancer is about 36.
0%
.
The platinum-containing regimen is an effective first-line treatment regimen for patients with advanced urothelial cancer, but after a period of time, patients are prone to drug resistance to chemotherapy, leading to tumor recurrence and progression
.
At present, PD-1/PD-L1 immunotherapy is the second-line recommendation for second-line treatment in China, but the overall remission rate is only about 20%, and the first-level recommendation is still to participate in clinical research
.
Moreover, patients are prone to local and systemic complications during treatment
.
Local complications include chemical cystitis, which can lead to lower urinary tract symptoms such as urgency, frequent urination, pain, or hematuria
.
Systemic complications can lead to systemic symptoms such as bone marrow suppression and renal insufficiency
.
In general, the current second-line treatment of advanced metastatic urothelial carcinoma still lacks effective means
.
The clinical information registration platform for advanced metastatic urothelial cancer is mainly the clinical research of PD-1/PD-L1 products
.
Among them, an open, single-arm, multi-center phase II clinical trial of MRG002 for the treatment of HER2-positive unresectable locally advanced or metastatic urothelial carcinoma after at least first-line systemic chemotherapy was launched in February 2021
.
A subject admitted by Prof.
Han Weiqing’s team from Hunan Cancer Hospital, treated with MRG002 for only 6 weeks, the bladder mass disappeared (14.
2mm to 0mm), the retroperitoneal lymph nodes were greatly reduced (15.
5mm to 6.
5mm), and the total diameter of the target lesion Compared with the baseline, it is significantly reduced by nearly 78% (29.
3mm to 6.
5mm), and the effect is surprising
.
Brief introduction of medical records and trial enrollment The patient was a male who was diagnosed with urothelial carcinoma in September 2019.
After various treatment options such as surgery, chemotherapy and immunotherapy, the disease continued to progress and metastasize (Table 1)
.
Table 1.
After the summary of the previous diagnosis and treatment, the patients were enrolled in MRG002 to treat HER2-positive unresectable locally advanced or metastatic urothelial carcinoma after at least first-line systemic chemotherapy.
Open, single-arm, multi-center phase II clinical trial, accepting MRG002 Single-drug therapy, after 2 cycles of treatment, all non-target lesions disappeared, one target lesion disappeared, and the retroperitoneal lymph node of the other target lesion shrank to 6.
5 mm.
See the following figure for details: Figure 1.
Baseline of bladder mass (left) and first medication Bladder mass after 6 weeks (right) Figure 2.
Retroperitoneal lymph node baseline (left) and retroperitoneal lymph node 6 weeks after the first medication (right) Case review At present, platinum-based combination chemotherapy is recurrent and metastatic urinary tract The basic treatment for skin cancer, but the survival benefit of patients is limited
.
For treatment options after chemotherapy is invalid, immunotherapy and ADC are currently the most concerned
.
Before MRG002 treatment, this patient had been treated with chemotherapy and immunotherapy for up to six months, but the target lesions continued to increase
.
In the case of receiving MRG002 treatment for only 6 weeks, both the target and non-target lesions were significantly reduced, and the efficacy assessment reached a complete remission (CR), which is expected to translate into a longer survival benefit for patients, indicating that MRG002 treatment is local The preliminary curative effect of advanced or metastatic urothelial carcinoma, and suggests that MRG002 still performs well for HER2-positive advanced urothelial carcinoma that is ineffective in chemotherapy combined with immunotherapy
.
MRG002 can achieve such obvious curative effect is closely related to its unique structure and innovative mechanism of action.
MRG002 is currently a promising ADC drug in the field of tumors [the sugar-modified trastuzumab can be cleaved through the vc linker and auristatin E (MMAE) conjugated], through the unique design and innovative improvement of trastuzumab, it can improve the safety and tolerability of patients while ensuring the enhancement of anti-tumor efficacy
.
With the high affinity of trastuzumab, it specifically binds to the HER2 antigen on the surface of tumor cells, internalizes and releases the cytotoxic payload MMAE, effectively inhibits tubulin polymerization, thereby interfering with microtubule-related functions (such as mitosis), resulting in Tumor cells die
.
In addition, the innovative modified trastuzumab has a selective higher fucosylation level in the Fc region, resulting in reduced binding of Fc to effector immune cells, so as to minimize the potential killing of immune cells by MRG002, thereby reducing the risk to patients Potential adverse immune related effects
.
At present, no drugs for the treatment of HER2-positive urothelial cancer have been approved for marketing at home and abroad, and the HER2 positive rate of urothelial cancer is about 36.
0%, which shows that the development of urothelial cancer treatment drugs with HER2 as the target is very important.
The direction of potential exploration
.
MRG002 is a new-generation ADC drug targeting HER2, which combines the advantages of monoclonal antibody targeting, strong selectivity and high anti-tumor activity of cytotoxic drugs, and is more optimized in chemical design, compared with the targeted targeting on the market.
HER2 ADC drugs have shown certain competitive advantages in the field of solid tumor treatment
.
It is hoped that in the field of HER2-positive urothelial cancer treatment, MRG002 can continue to make progress, bring more excellent performance, and fill the treatment gap in this clinical field as soon as possible
.
At present, it is sponsored by Shanghai Miac Biotechnology Co.
, Ltd.
, a subsidiary of Lepu Biotech, and led by Professor Zhou Aiping from the Cancer Hospital of the Chinese Academy of Medical Sciences and Professor Zhou Fangjian from the Cancer Center of Sun Yat-sen University.
The open, single-arm, multi-center phase II clinical trial of locally advanced or metastatic urothelial cancer" was carried out in more than 20 centers across the country.
The selected patients can receive free ADC drug treatment.
"HER2-positive patients who are diagnosed as unable to Patients with locally advanced or metastatic urothelial carcinoma undergoing surgical resection are welcome to consult
.
If you are interested in this clinical research, you can contact 021-61637960; you can also check the outpatient time of each researcher on the Internet for consultation: *This article is only used to provide scientific information to medical professionals, and does not represent the views of this platform
