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Urothelial carcinoma is a common type of bladder cancer, accounting for more than 90% of all bladder cancer cases.
Although it is not as high as lung cancer and breast cancer, it is easy to metastasize and relapse, and treatments are limited, which seriously threatens the survival time and quality of life of patients.
Fortunately, the National Medical Products Administration of China recently approved Tuoyi® (Treplimumab Injection) for the use of platinum-containing chemotherapy failures including neoadjuvant or adjuvant chemotherapy that progressed within 12 months of locally advanced or metastatic urothelium Cancer treatment.
As the first approved immunotherapy drug for the whole population of advanced urothelial cancer in China, Tuoyi® does not require PD-L1 expression detection before administration, and the price is lower, which will bring hope to more urothelial cancer patients.
The first domestic immunotherapy drug for the whole population of advanced urothelial cancer, benefiting more patients at the same time, the efficacy is more significant.
According to the clinical data released at the time of approval, Tuoyi® has shown good anti-tumor effectiveness and Safety: The approval of this new indication is based on the POLARIS-03 study, which is an open, multi-center, single-arm, phase II clinical study.
The results showed that among the 136 patients with locally advanced or metastatic urothelial cancer who had failed platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy, had progressed within 12 months, the overall objective response rate (ORR) of the population was 27.
2%, and the disease control rate (DCR) was 46.
3%, and the median overall survival (mOS) was 14.
6 months; among the people with high PD-L1 expression, mOS reached 35.
6 months! (Median overall survival data chart) The median duration of response (DoR) is not yet mature, and among the subjects who achieved an objective response, 67.
1% of subjects still had sustained response at 12 months.
It is worth noting that Tuoyi® is the first PD-1 immunotherapy drug in China that can be used for the entire population of advanced urothelial cancer that has failed the first-line standard treatment, without the need for PD-L1 expression detection.
Data from the POLARIS-03 study showed that Teriplimumab showed clear anti-tumor activity and sustained effectiveness in the overall population and subgroups: _ORR1 year overall survival rate of the overall population 27.
2% 51.
4% PD-L1 positive Population 42.
2% 54.
4% PD-L1 negative population 18.
8% 48.
5% As can be seen from the above table, patients with advanced urothelial cancer can benefit regardless of the PD-L1 expression status.
In addition, the safety and tolerability of teriprizumab in patients with advanced urothelial cancer are consistent with the results of previous studies.
According to the efficacy data of PD-1/PD-L1 second-line treatment of advanced urothelial cancer published abroad, the objective remission rate is generally about 20%, and the median overall survival is mostly about 10 months, while POLARIS-03 Studies have shown that the median overall survival of the overall population reaches 14.
6 months, and the patient's survival benefit has been significantly improved.
Lower prices, easier purchase, and more patients benefit.
The Tuoyi® advanced urothelial cancer indication has just been approved but has not entered the medical insurance.
Will the price of medication for patients with urothelial cancer be unaffordable? The answer is no! The economic burden caused by disease treatment is the first factor to be considered for patients.
It is understood that the current price of Tuoyi® (80mg) is 906.
08 yuan, and the patient's annual treatment cost is about 70,000 yuan.
Compared with the previous treatment cost of hundreds of thousands a year, the current treatment cost has been reduced a lot.
In addition to the urothelial cancer approved this time, Tuoyi® has been approved for melanoma and nasopharyngeal cancer, and can be purchased at more than 2,000 designated pharmacies across the country, covering provinces, cities, prefecture-level cities and even some counties.
It is more convenient for patients to purchase medicines.
Please see the end of the article for a detailed list.
Join forces to jointly advance the level of tumor diagnosis and treatment Junshi Biotech’s approved Tuoyi® urothelial cancer indication will be marketed by AstraZeneca China’s full agency.
This change originated from AstraZeneca China and Junshi Biotech’s In-depth strategic cooperation announced in February this year. It is understood that Junshi Biology has carried out more than 30 clinical studies around the world, and actively explores Tuoyi® in melanoma, nasopharyngeal cancer, urothelial cancer, lung cancer, gastric cancer, esophageal cancer, liver cancer, cholangiocarcinoma, and breast cancer.
The efficacy and safety of indications such as, kidney cancer, etc.
, more indications may be approved in the future.
The approval of the new indications of Tuoyi® hopes that more patients with advanced urothelial cancer can benefit, while surviving with the tumor, and obtain a better quality of life.
Although it is not as high as lung cancer and breast cancer, it is easy to metastasize and relapse, and treatments are limited, which seriously threatens the survival time and quality of life of patients.
Fortunately, the National Medical Products Administration of China recently approved Tuoyi® (Treplimumab Injection) for the use of platinum-containing chemotherapy failures including neoadjuvant or adjuvant chemotherapy that progressed within 12 months of locally advanced or metastatic urothelium Cancer treatment.
As the first approved immunotherapy drug for the whole population of advanced urothelial cancer in China, Tuoyi® does not require PD-L1 expression detection before administration, and the price is lower, which will bring hope to more urothelial cancer patients.
The first domestic immunotherapy drug for the whole population of advanced urothelial cancer, benefiting more patients at the same time, the efficacy is more significant.
According to the clinical data released at the time of approval, Tuoyi® has shown good anti-tumor effectiveness and Safety: The approval of this new indication is based on the POLARIS-03 study, which is an open, multi-center, single-arm, phase II clinical study.
The results showed that among the 136 patients with locally advanced or metastatic urothelial cancer who had failed platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy, had progressed within 12 months, the overall objective response rate (ORR) of the population was 27.
2%, and the disease control rate (DCR) was 46.
3%, and the median overall survival (mOS) was 14.
6 months; among the people with high PD-L1 expression, mOS reached 35.
6 months! (Median overall survival data chart) The median duration of response (DoR) is not yet mature, and among the subjects who achieved an objective response, 67.
1% of subjects still had sustained response at 12 months.
It is worth noting that Tuoyi® is the first PD-1 immunotherapy drug in China that can be used for the entire population of advanced urothelial cancer that has failed the first-line standard treatment, without the need for PD-L1 expression detection.
Data from the POLARIS-03 study showed that Teriplimumab showed clear anti-tumor activity and sustained effectiveness in the overall population and subgroups: _ORR1 year overall survival rate of the overall population 27.
2% 51.
4% PD-L1 positive Population 42.
2% 54.
4% PD-L1 negative population 18.
8% 48.
5% As can be seen from the above table, patients with advanced urothelial cancer can benefit regardless of the PD-L1 expression status.
In addition, the safety and tolerability of teriprizumab in patients with advanced urothelial cancer are consistent with the results of previous studies.
According to the efficacy data of PD-1/PD-L1 second-line treatment of advanced urothelial cancer published abroad, the objective remission rate is generally about 20%, and the median overall survival is mostly about 10 months, while POLARIS-03 Studies have shown that the median overall survival of the overall population reaches 14.
6 months, and the patient's survival benefit has been significantly improved.
Lower prices, easier purchase, and more patients benefit.
The Tuoyi® advanced urothelial cancer indication has just been approved but has not entered the medical insurance.
Will the price of medication for patients with urothelial cancer be unaffordable? The answer is no! The economic burden caused by disease treatment is the first factor to be considered for patients.
It is understood that the current price of Tuoyi® (80mg) is 906.
08 yuan, and the patient's annual treatment cost is about 70,000 yuan.
Compared with the previous treatment cost of hundreds of thousands a year, the current treatment cost has been reduced a lot.
In addition to the urothelial cancer approved this time, Tuoyi® has been approved for melanoma and nasopharyngeal cancer, and can be purchased at more than 2,000 designated pharmacies across the country, covering provinces, cities, prefecture-level cities and even some counties.
It is more convenient for patients to purchase medicines.
Please see the end of the article for a detailed list.
Join forces to jointly advance the level of tumor diagnosis and treatment Junshi Biotech’s approved Tuoyi® urothelial cancer indication will be marketed by AstraZeneca China’s full agency.
This change originated from AstraZeneca China and Junshi Biotech’s In-depth strategic cooperation announced in February this year. It is understood that Junshi Biology has carried out more than 30 clinical studies around the world, and actively explores Tuoyi® in melanoma, nasopharyngeal cancer, urothelial cancer, lung cancer, gastric cancer, esophageal cancer, liver cancer, cholangiocarcinoma, and breast cancer.
The efficacy and safety of indications such as, kidney cancer, etc.
, more indications may be approved in the future.
The approval of the new indications of Tuoyi® hopes that more patients with advanced urothelial cancer can benefit, while surviving with the tumor, and obtain a better quality of life.
