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February 22, 2022 / eMedClub News / -- Urothelial carcinoma (UC) is a relatively common type of advanced urinary tumors
.
The mortality rate of UC in China remains high.
Therefore, the diagnosis and treatment of UC and the problems it faces are still very serious
.
Recently, Merck KGaA announced positive long-term efficacy data from the Phase 3 JAVELIN Bladder 100 trial of its co-developed PD-L1 inhibitor BAVENCIO with Pfizer
.
These results were presented at the 2022 American Society of Clinical Oncology Annual Genitourinary Cancers Symposium (ASCO-GU), held February 17-19, 2022
.
Data show that in patients with locally advanced or mUC, BAVENCIO as first-line maintenance therapy and best supportive care (BSC) combined with BSC alone improved median overall survival (OS) by 8.
8 months, compared with 2020 Compared with the trial data published at ASCO, the OS benefit continued to improve
.
BAVENCIO remains the first immunotherapy to successfully improve first-line survival in patients with locally advanced or metastatic urothelial carcinoma (mUC)
.
Specific data Median OS was 23.
8 months (95%CI, 19.
9 to 28.
8) in the Bavencio/BSC arm; 15.
0 months (95%CI, 13.
5 to 18.
2) in the control arm (HR 0.
76; 95%CI, 0.
631 to 0.
915)
.
At 30 months, survival was 43.
7% (95% CI, 38.
2% to 49.
0%) in the Bavencio/BSC group and 33.
5% (95% CI, 28.
4% to 38.
7%) in the control group
.
In the PD-L1-positive tumor patient population (n = 358): median OS was 30.
9 months (95% CI, 24.
0-39.
8) in the Bavencio/BSC group and 18.
5 months in the control group (95% CI, 14.
1-24.
2) ) (HR=0.
69; 95% CI, 0.
521-0.
901)
.
At 30 months, more than half (51.
3%; 95% CI, 43.
7%-58.
4%) of patients in the Bavencio/BSC group were alive compared with 38.
5% (95% CI, 30.
9%-46.
1%) in the control group
.
In addition, the safety profile of BAVENCIO was consistent with the entire JAVELIN monotherapy clinical development program, with no new safety signals
.
About BAVENCIO BAVENCIO is a humanized anti-PD-L1 IgG1 monoclonal antibody
.
In preclinical models, BAVENCIO has been shown to have both adaptive and innate immune functions
.
Preclinical studies have shown that by blocking the interaction between PD-L1 and PD-1 receptors, BAVENCIO can release inhibition of T cell-mediated anti-tumor immune responses; by retaining the native Fc region, BAVENCIO can bind to the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC)
.
"Locally advanced and mUC have low five-year survival rates and high recurrence rates, so additional agents are needed to maintain the benefits of chemotherapy and improve survival," said Dr.
Victoria Zazulina, Head of Oncology Development at Merck, Germany
.
In the
JAVELIN Bladder 100 trial The continued improvement in overall survival further supports the use of BAVENCIO as first-line maintenance therapy in patients whose disease has not progressed on platinum-based chemotherapy and reinforces our commitment to further evaluate BAVENCIO in advanced bladder cancer
.
"Exploration of the treatment of urothelial carcinoma Urothelial carcinoma (UC) is the most common malignant tumor of the genitourinary system, and is divided into upper urothelial carcinoma and bladder cancer
.
According to statistics, about 90% of UC occurs in the bladder,8 % occurred in the renal pelvis, and 2% occurred in the ureter or urethra
.
Surgery is the main treatment for early UC, and platinum-based chemotherapy is the standard first-line treatment for patients with inoperable locally advanced or mUC.
Decrease, which will lead to tumor recurrence and disease progression.
For such advanced UC patients with disease progression after standard treatment, treatment options are limited
.
In recent years, immunotherapy has gradually received attention in the treatment of genitourinary tumors, with PD-1/PD -L1 monoclonal antibody as the representative of immunotherapy drugs, antibody-conjugated drugs (ADC), targeted therapy and other new treatments have made breakthroughs one after another, bringing new hope to UC patients
.
ADC drug therapy: ADC drugs are undoubtedly the field of UC.
There are many ADC drugs at home and abroad that have shown good efficacy in patients with advanced UC after failure of conventional treatment, and have become the treatment recommendation of domestic and foreign guidelines and the routine choice of clinical practice
.
➤ February 2020, Seattle Genetics/Astellas Pharma and Merck have reached a cooperation agreement to conduct a clinical trial of Padcev in combination with Keytruda (pembrolizumab) for the first-line treatment of locally advanced or mUC
.
In March 2021, Seattle Genetics (Seattle Genetics) and Astellas (Astellas) ) jointly announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for the ADC drug Padcev for the treatment of adult patients with locally advanced or mUC
.
In July 2021, the U.
S.
Food and Drug Administration granted Padcev conventional approval and expanded indication for the treatment of adult patients with locally advanced or mUC who are ineligible for cisplatin-based chemotherapy and have previously received first or multiple lines of therapy
.
In fact, as early as December 2019, Padcev has received accelerated approval from the US FDA for the treatment of patients with locally advanced or mUC
.
It is worth mentioning that Padcev is the world's first ADC drug approved for the treatment of UC, and the first approved for locally advanced or mUC patients who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
of drugs
.
Recommended reading: US FDA grants routine approval and expanded indications for new ADC drug PadcevYimai Meng broke the news ➤ In July 2021, Rongchang Bio’s marketing application for HER2-targeting ADC drug vedicetumab was accepted by the China Food and Drug Administration , for the treatment of HER2-overexpressing locally advanced or mUC
.
At the ASCO in 2021, Rongchang Bio announced the relevant data of the phase 1b/2 study of vildicotumab
.
Preliminary results showed that the objective response rate (ORR) reached 100% in 16 patients with HER2 overexpression in 16 patients with varying degrees of HER2 overexpression
.
In addition, for UC patients who have undergone second-line or above systemic chemotherapy, vellicitumab monotherapy has also shown good efficacy and survival benefits
.
The objective response rate by independent imaging assessment was 50%, the median progression-free survival was 5.
1 months, and the median survival was 14.
2 months
.
As early as September and December 2020, the drug for the treatment of UC indications has successively obtained breakthrough therapy certifications from the US FDA and the China Food and Drug Administration, becoming the first ADC to receive dual breakthrough therapy certifications in China and the United States.
drug
.
Recommended reading: Domestic ADC new drug submits a second indication (NMPA) approved for the treatment of patients with locally advanced or mPD-L1-high UC who have failed platinum-based chemotherapy
.
Domestic UC has officially entered the era of immunotherapy
.
The approval of this indication is based on the results of the Phase II clinical study of tislelizumab
.
A total of 113 patients with advanced UC who had failed at least first-line chemotherapy were included in the trial
.
The results showed that among the 101 patients with evaluable efficacy, the ORR reached 24.
8%, of which 9.
9% achieved complete remission (CR)
.
➤ In April 2021, Junshi Bio-Toripalimab injection was approved by China's NMPA for the treatment of locally advanced or m-urothelial urothelium who have failed platinum-based chemotherapy, including neoadjuvant or adjuvant chemotherapy that progressed within 12 months cancer treatment
.
Toripalimab injection is the first domestically produced monoclonal antibody targeting PD-1 approved for marketing in China
.
In addition, on April 12, 2019, Janssen's Balversa (erdafitinib) was approved by the FDA, becoming the first FDA-approved targeted therapy for bladder cancer for the treatment of FGFR3 or FGFR2 mutations that progress after platinum-based chemotherapy.
locally advanced disease or mUC, which provides an additional option for the extremely limited second-line treatment options for patients with mUC
.
However, it is worth noting that FGFR mutations only account for about 20% of patients with relapsed advanced UC
.
Therefore, most UC patients who need second-line treatment are still in the predicament of no cure for a long time, and it is particularly urgent to develop effective treatment methods for such patients
.
With the continuous application of more and more new drugs, the precise era of UC treatment is coming
.
Reference: 1.
http:// -patients-with-advanced-urothelial-carcinoma/2.
https://
.
The mortality rate of UC in China remains high.
Therefore, the diagnosis and treatment of UC and the problems it faces are still very serious
.
Recently, Merck KGaA announced positive long-term efficacy data from the Phase 3 JAVELIN Bladder 100 trial of its co-developed PD-L1 inhibitor BAVENCIO with Pfizer
.
These results were presented at the 2022 American Society of Clinical Oncology Annual Genitourinary Cancers Symposium (ASCO-GU), held February 17-19, 2022
.
Data show that in patients with locally advanced or mUC, BAVENCIO as first-line maintenance therapy and best supportive care (BSC) combined with BSC alone improved median overall survival (OS) by 8.
8 months, compared with 2020 Compared with the trial data published at ASCO, the OS benefit continued to improve
.
BAVENCIO remains the first immunotherapy to successfully improve first-line survival in patients with locally advanced or metastatic urothelial carcinoma (mUC)
.
Specific data Median OS was 23.
8 months (95%CI, 19.
9 to 28.
8) in the Bavencio/BSC arm; 15.
0 months (95%CI, 13.
5 to 18.
2) in the control arm (HR 0.
76; 95%CI, 0.
631 to 0.
915)
.
At 30 months, survival was 43.
7% (95% CI, 38.
2% to 49.
0%) in the Bavencio/BSC group and 33.
5% (95% CI, 28.
4% to 38.
7%) in the control group
.
In the PD-L1-positive tumor patient population (n = 358): median OS was 30.
9 months (95% CI, 24.
0-39.
8) in the Bavencio/BSC group and 18.
5 months in the control group (95% CI, 14.
1-24.
2) ) (HR=0.
69; 95% CI, 0.
521-0.
901)
.
At 30 months, more than half (51.
3%; 95% CI, 43.
7%-58.
4%) of patients in the Bavencio/BSC group were alive compared with 38.
5% (95% CI, 30.
9%-46.
1%) in the control group
.
In addition, the safety profile of BAVENCIO was consistent with the entire JAVELIN monotherapy clinical development program, with no new safety signals
.
About BAVENCIO BAVENCIO is a humanized anti-PD-L1 IgG1 monoclonal antibody
.
In preclinical models, BAVENCIO has been shown to have both adaptive and innate immune functions
.
Preclinical studies have shown that by blocking the interaction between PD-L1 and PD-1 receptors, BAVENCIO can release inhibition of T cell-mediated anti-tumor immune responses; by retaining the native Fc region, BAVENCIO can bind to the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC)
.
"Locally advanced and mUC have low five-year survival rates and high recurrence rates, so additional agents are needed to maintain the benefits of chemotherapy and improve survival," said Dr.
Victoria Zazulina, Head of Oncology Development at Merck, Germany
.
In the
JAVELIN Bladder 100 trial The continued improvement in overall survival further supports the use of BAVENCIO as first-line maintenance therapy in patients whose disease has not progressed on platinum-based chemotherapy and reinforces our commitment to further evaluate BAVENCIO in advanced bladder cancer
.
"Exploration of the treatment of urothelial carcinoma Urothelial carcinoma (UC) is the most common malignant tumor of the genitourinary system, and is divided into upper urothelial carcinoma and bladder cancer
.
According to statistics, about 90% of UC occurs in the bladder,8 % occurred in the renal pelvis, and 2% occurred in the ureter or urethra
.
Surgery is the main treatment for early UC, and platinum-based chemotherapy is the standard first-line treatment for patients with inoperable locally advanced or mUC.
Decrease, which will lead to tumor recurrence and disease progression.
For such advanced UC patients with disease progression after standard treatment, treatment options are limited
.
In recent years, immunotherapy has gradually received attention in the treatment of genitourinary tumors, with PD-1/PD -L1 monoclonal antibody as the representative of immunotherapy drugs, antibody-conjugated drugs (ADC), targeted therapy and other new treatments have made breakthroughs one after another, bringing new hope to UC patients
.
ADC drug therapy: ADC drugs are undoubtedly the field of UC.
There are many ADC drugs at home and abroad that have shown good efficacy in patients with advanced UC after failure of conventional treatment, and have become the treatment recommendation of domestic and foreign guidelines and the routine choice of clinical practice
.
➤ February 2020, Seattle Genetics/Astellas Pharma and Merck have reached a cooperation agreement to conduct a clinical trial of Padcev in combination with Keytruda (pembrolizumab) for the first-line treatment of locally advanced or mUC
.
In March 2021, Seattle Genetics (Seattle Genetics) and Astellas (Astellas) ) jointly announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for the ADC drug Padcev for the treatment of adult patients with locally advanced or mUC
.
In July 2021, the U.
S.
Food and Drug Administration granted Padcev conventional approval and expanded indication for the treatment of adult patients with locally advanced or mUC who are ineligible for cisplatin-based chemotherapy and have previously received first or multiple lines of therapy
.
In fact, as early as December 2019, Padcev has received accelerated approval from the US FDA for the treatment of patients with locally advanced or mUC
.
It is worth mentioning that Padcev is the world's first ADC drug approved for the treatment of UC, and the first approved for locally advanced or mUC patients who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
of drugs
.
Recommended reading: US FDA grants routine approval and expanded indications for new ADC drug PadcevYimai Meng broke the news ➤ In July 2021, Rongchang Bio’s marketing application for HER2-targeting ADC drug vedicetumab was accepted by the China Food and Drug Administration , for the treatment of HER2-overexpressing locally advanced or mUC
.
At the ASCO in 2021, Rongchang Bio announced the relevant data of the phase 1b/2 study of vildicotumab
.
Preliminary results showed that the objective response rate (ORR) reached 100% in 16 patients with HER2 overexpression in 16 patients with varying degrees of HER2 overexpression
.
In addition, for UC patients who have undergone second-line or above systemic chemotherapy, vellicitumab monotherapy has also shown good efficacy and survival benefits
.
The objective response rate by independent imaging assessment was 50%, the median progression-free survival was 5.
1 months, and the median survival was 14.
2 months
.
As early as September and December 2020, the drug for the treatment of UC indications has successively obtained breakthrough therapy certifications from the US FDA and the China Food and Drug Administration, becoming the first ADC to receive dual breakthrough therapy certifications in China and the United States.
drug
.
Recommended reading: Domestic ADC new drug submits a second indication (NMPA) approved for the treatment of patients with locally advanced or mPD-L1-high UC who have failed platinum-based chemotherapy
.
Domestic UC has officially entered the era of immunotherapy
.
The approval of this indication is based on the results of the Phase II clinical study of tislelizumab
.
A total of 113 patients with advanced UC who had failed at least first-line chemotherapy were included in the trial
.
The results showed that among the 101 patients with evaluable efficacy, the ORR reached 24.
8%, of which 9.
9% achieved complete remission (CR)
.
➤ In April 2021, Junshi Bio-Toripalimab injection was approved by China's NMPA for the treatment of locally advanced or m-urothelial urothelium who have failed platinum-based chemotherapy, including neoadjuvant or adjuvant chemotherapy that progressed within 12 months cancer treatment
.
Toripalimab injection is the first domestically produced monoclonal antibody targeting PD-1 approved for marketing in China
.
In addition, on April 12, 2019, Janssen's Balversa (erdafitinib) was approved by the FDA, becoming the first FDA-approved targeted therapy for bladder cancer for the treatment of FGFR3 or FGFR2 mutations that progress after platinum-based chemotherapy.
locally advanced disease or mUC, which provides an additional option for the extremely limited second-line treatment options for patients with mUC
.
However, it is worth noting that FGFR mutations only account for about 20% of patients with relapsed advanced UC
.
Therefore, most UC patients who need second-line treatment are still in the predicament of no cure for a long time, and it is particularly urgent to develop effective treatment methods for such patients
.
With the continuous application of more and more new drugs, the precise era of UC treatment is coming
.
Reference: 1.
http:// -patients-with-advanced-urothelial-carcinoma/2.
https://
