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Recently, the "2021 Beijing Urinary Oncology Youth Forum and Year-end Inventory of Urinary Oncology" hosted by the Beijing Anti-Cancer Association and Beijing Medical Awards Foundation was held on January 10, 2021 in the form of a network + on-site meeting and ended successfully.
During the conference, Professor Wang Dong from the Cancer Hospital of the Chinese Academy of Medical Sciences introduced the important progress of advanced urothelial cancer immunotherapy and immunotherapy with the title of "Advances in immunotherapy of advanced urothelial cancer".
Expert profile Prof.
Dong Wang, Associate Chief Physician, Department of Urology, Cancer Hospital, Chinese Academy of Medical Sciences, Member of the Committee of Urinary and Male Reproductive System Tumors, Beijing Anti-Cancer Association, Deputy Chairman of the Youth Committee of the Department of Urinary and Male Reproductive System Tumors, Beijing Anti-Cancer Association Committee member Chinese Anti-Cancer Association Photodynamic Professional Committee Member important research progress in second-line treatment At present, foreign guidelines recommend a total of five immune checkpoint inhibitors for the second-line treatment of advanced urothelial cancer.
The objective response rate (ORR) of these five drugs is 20% to 30%, and the median overall survival (OS) is about 10 months.
In China, some progress has also been made in research related to the second-line treatment of advanced urothelial cancer.
Summary of five drug-related research data Second-line monotherapy: BGB-A317 204 study, POLARIS-03 study At the 2019 ESMO conference, the investigator announced the phase II BGB-A317 204 study of tislelizumab in the treatment of advanced urinary tract Research data on skin cancer.
The results showed that the patient’s ORR was 24.
1%, the complete response rate (CR) was as high as 9.
9%, and the median OS was 9.
8 months.
At present, tislelizumab has been approved by the CDE for locally advanced or metastatic urothelial cancer patients who have previously received treatment.
It is the first immune checkpoint inhibitor in China to obtain an indication for urothelial cancer.The POLARIS-03 study is a phase II single-arm, multi-center clinical study, which aims to evaluate the efficacy and safety of teriprizumab as a single agent in the treatment of advanced urothelial cancer.
Subgroup analysis showed that among PD-L1 positive patients, ORR was as high as 41.
3%, which is currently the highest value of ORR for single-agent second-line therapy.
The ORR of PD-L1 negative patients was 16.
8%.
Second-line combination therapy: PEANUT study The PEANUT study aims to explore the efficacy and safety of pembrolizumab combined with albumin paclitaxel in patients with advanced urothelial cancer who have failed chemotherapy.
The results showed that the patient's ORR was 38.
6%.
Important research progress in first-line treatment Professor Wang said that in the field of first-line treatment of advanced urothelial cancer, combination therapy is the inevitable direction of future development.
There are many phase III clinical studies on the first-line combination therapy currently underway, including chemotherapy combined with immunotherapy, dual immune combined therapy, etc.
However, the available data did not yield significant results.
A summary of domestic and foreign first-line treatment related studies: Imvigor130 study IMVIGOR130 study is divided into three experimental groups: platinum-containing chemotherapy combined with atilizumab, chemotherapy combined with placebo, and atilizumab single agent, aiming to compare The efficacy and safety of each group of drugs in the first-line treatment of locally advanced or metastatic urothelial carcinoma.
The data showed that compared with the placebo group, the median OS and median progression-free survival (PFS) of patients in the chemotherapy plus atilizumab group were prolonged to 16 months and 8.
2 months, respectively.
Regrettably, it did not reach the result that the researcher initially presupposed.
Immune combined antibody conjugate drugs: The EV-103 study phase II EV-103 study evaluated the effectiveness and safety of Enfortumab Vedotin+pembrolizumab in the treatment of locally advanced or metastatic urothelial cancer.
The results showed that the ORR of patients with high PD-L1 expression and low PD-L1 expression were 78.
6% and 63.
2%, respectively, and the curative effect was better. However, the sample size of the study is relatively small.
Therefore, the efficacy of antibody-conjugated drugs combined with immunosuppressive agents needs further study.
Immune single-agent maintenance after first-line treatment: JAVELIN Bladder100 study Professor Wang said that the JAVELIN Bladder100 study is a heavyweight study in 2020.
The study included patients who had stable or remission after standard first-line chemotherapy and were given Avelumab maintenance treatment.
The study found that compared with the placebo group, patients in the experimental group had significantly longer OS.
Among PD-L1 positive patients, the trial group can reduce the risk of death by 44% compared with the placebo group.
The JAVELIN Bladder100 study shows that immune maintenance therapy after first-line chemotherapy can prolong the OS of patients with bladder cancer.
Therefore, for patients with locally advanced or metastatic urothelial cancer without disease progression after first-line chemotherapy, Avelumab first-line maintenance therapy can become a new standard treatment option.
Summary Professor Wang said that whether it is the first-line or second-line treatment of advanced urothelial cancer, immune monotherapy and combination therapy have significantly improved the efficacy and have gradually become the mainstream of current research and clinical treatment.
In 2020, the clinical trial data of domestic research is exciting.
For first-line treatment, combination therapy is the future development trend.
Appropriate combination strategies and subdivided populations may maximize the benefits of patients, and the emergence of antibody-conjugated drugs and targeted drugs may shake the status of first-line platinum drugs.
In addition, single-agent immune maintenance therapy after first-line treatment can bring significant survival benefits to patients and provide new treatment ideas for maintenance therapy.
During the conference, Professor Wang Dong from the Cancer Hospital of the Chinese Academy of Medical Sciences introduced the important progress of advanced urothelial cancer immunotherapy and immunotherapy with the title of "Advances in immunotherapy of advanced urothelial cancer".
Expert profile Prof.
Dong Wang, Associate Chief Physician, Department of Urology, Cancer Hospital, Chinese Academy of Medical Sciences, Member of the Committee of Urinary and Male Reproductive System Tumors, Beijing Anti-Cancer Association, Deputy Chairman of the Youth Committee of the Department of Urinary and Male Reproductive System Tumors, Beijing Anti-Cancer Association Committee member Chinese Anti-Cancer Association Photodynamic Professional Committee Member important research progress in second-line treatment At present, foreign guidelines recommend a total of five immune checkpoint inhibitors for the second-line treatment of advanced urothelial cancer.
The objective response rate (ORR) of these five drugs is 20% to 30%, and the median overall survival (OS) is about 10 months.
In China, some progress has also been made in research related to the second-line treatment of advanced urothelial cancer.
Summary of five drug-related research data Second-line monotherapy: BGB-A317 204 study, POLARIS-03 study At the 2019 ESMO conference, the investigator announced the phase II BGB-A317 204 study of tislelizumab in the treatment of advanced urinary tract Research data on skin cancer.
The results showed that the patient’s ORR was 24.
1%, the complete response rate (CR) was as high as 9.
9%, and the median OS was 9.
8 months.
At present, tislelizumab has been approved by the CDE for locally advanced or metastatic urothelial cancer patients who have previously received treatment.
It is the first immune checkpoint inhibitor in China to obtain an indication for urothelial cancer.The POLARIS-03 study is a phase II single-arm, multi-center clinical study, which aims to evaluate the efficacy and safety of teriprizumab as a single agent in the treatment of advanced urothelial cancer.
Subgroup analysis showed that among PD-L1 positive patients, ORR was as high as 41.
3%, which is currently the highest value of ORR for single-agent second-line therapy.
The ORR of PD-L1 negative patients was 16.
8%.
Second-line combination therapy: PEANUT study The PEANUT study aims to explore the efficacy and safety of pembrolizumab combined with albumin paclitaxel in patients with advanced urothelial cancer who have failed chemotherapy.
The results showed that the patient's ORR was 38.
6%.
Important research progress in first-line treatment Professor Wang said that in the field of first-line treatment of advanced urothelial cancer, combination therapy is the inevitable direction of future development.
There are many phase III clinical studies on the first-line combination therapy currently underway, including chemotherapy combined with immunotherapy, dual immune combined therapy, etc.
However, the available data did not yield significant results.
A summary of domestic and foreign first-line treatment related studies: Imvigor130 study IMVIGOR130 study is divided into three experimental groups: platinum-containing chemotherapy combined with atilizumab, chemotherapy combined with placebo, and atilizumab single agent, aiming to compare The efficacy and safety of each group of drugs in the first-line treatment of locally advanced or metastatic urothelial carcinoma.
The data showed that compared with the placebo group, the median OS and median progression-free survival (PFS) of patients in the chemotherapy plus atilizumab group were prolonged to 16 months and 8.
2 months, respectively.
Regrettably, it did not reach the result that the researcher initially presupposed.
Immune combined antibody conjugate drugs: The EV-103 study phase II EV-103 study evaluated the effectiveness and safety of Enfortumab Vedotin+pembrolizumab in the treatment of locally advanced or metastatic urothelial cancer.
The results showed that the ORR of patients with high PD-L1 expression and low PD-L1 expression were 78.
6% and 63.
2%, respectively, and the curative effect was better. However, the sample size of the study is relatively small.
Therefore, the efficacy of antibody-conjugated drugs combined with immunosuppressive agents needs further study.
Immune single-agent maintenance after first-line treatment: JAVELIN Bladder100 study Professor Wang said that the JAVELIN Bladder100 study is a heavyweight study in 2020.
The study included patients who had stable or remission after standard first-line chemotherapy and were given Avelumab maintenance treatment.
The study found that compared with the placebo group, patients in the experimental group had significantly longer OS.
Among PD-L1 positive patients, the trial group can reduce the risk of death by 44% compared with the placebo group.
The JAVELIN Bladder100 study shows that immune maintenance therapy after first-line chemotherapy can prolong the OS of patients with bladder cancer.
Therefore, for patients with locally advanced or metastatic urothelial cancer without disease progression after first-line chemotherapy, Avelumab first-line maintenance therapy can become a new standard treatment option.
Summary Professor Wang said that whether it is the first-line or second-line treatment of advanced urothelial cancer, immune monotherapy and combination therapy have significantly improved the efficacy and have gradually become the mainstream of current research and clinical treatment.
In 2020, the clinical trial data of domestic research is exciting.
For first-line treatment, combination therapy is the future development trend.
Appropriate combination strategies and subdivided populations may maximize the benefits of patients, and the emergence of antibody-conjugated drugs and targeted drugs may shake the status of first-line platinum drugs.
In addition, single-agent immune maintenance therapy after first-line treatment can bring significant survival benefits to patients and provide new treatment ideas for maintenance therapy.
