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*Only for medical professionals to read for reference, 1 minute a day, to give you professional "talking information" in the tumor circle! (If you need the original text of the literature, you can add to the editor WeChat yxj_oncology to obtain) Key points remind Liver Cancer: A+T regimen can change the treatment practice of Chinese patients with unresectable liver cancer Eur Urol: Atelizumab can make the local area that has received platinum-containing treatment New drug for long-term remission for patients with advanced or metastatic urothelial cancer: Teriplizumab as the first-line treatment for esophageal squamous cell carcinoma Phase III successful new drug: FDA accelerated approval of the first CD19 ADC targeted, and has been approved for clinical trials in China 01Liver Cancer: The A+T regimen can change the treatment practice of patients with unresectable liver cancer in China.
On April 23, Liver Cancer reported IMbrave150 study Chinese subgroup data showed that for patients with unresectable hepatocellular carcinoma (HCC) who have not received systemic treatment, Compared with sorafenib, atelizumab + bevacizumab (hereinafter referred to as A+T) has clinically significant improvements in overall survival (OS) and progression-free survival (PFS).
This indicates that A+T may become a plan to change the treatment practice of patients with unresectable HCC in China.
The article cover screenshot IMbrave150 is a global, randomized, open-label, phase III study in unresectable HCC patients who have not received systemic treatment, including an extended study in mainland China.
In the study, patients were randomly assigned (2:1) to receive intravenous infusion of atilizumab 1200 mg + bevacizumab 15 mg/kg (every 3 weeks) or sorafenib 400 mg (every 3 weeks).
2 times a day).
Global research results show that compared with sorafenib, A+T significantly improves OS and PFS in patients with unresectable HCC.
The efficacy and safety results of the Chinese subgroup population in this report show that of the 194 Chinese patients included (137 in the global study and 57 in the China Extended Study), 133 received A+T treatment, and 61 received Sorafenib treatment.
At the time of the data cutoff, the stratified hazard ratio for OS was 0.
44 (95% CI 0.
25-0.
76), and PFS was 0.
60 (95% CI 0.
40-0.
90).
The median OS of the A+T group and the sorafenib group were unreached (NR; 95% CI 13.
5 months-NR) and 11.
4 months (95% CI 6.
7-NR), respectively, and the median PFS was 5.
7 Months (95% CI 4.
2-8.
3) and 3.
2 months (95% CI 2.
6-4.
8).
In terms of safety, the incidence of grade 3-4 adverse events in the A+T group was 59.
1% (78/132), and that in the sorafenib group was 46.
6% (27/58).
The most common grade 3-4 adverse event in the A+T group was hypertension (15.
2%), but other high-grade adverse events were rare.
The researchers pointed out that compared with sorafenib, A+T achieved clinically significant improvements in OS and PFS.
Therefore, for Chinese patients with unresectable HCC, A+T should be regarded as a treatment that changes practice.
02Eur Urol: Atelizumab can provide long-term remission for patients with locally advanced or metastatic urothelial cancer who have received platinum-containing treatment.
On April 23, European Urology reported the OS and safety update data of the phase III IMvigor211 study .
The results show that for patients with locally advanced or metastatic urothelial carcinoma (mUC) who have received platinum-containing treatment, atelizumab treatment can achieve long-term and lasting remission with controllable safety.
Article cover screenshot IMvigor211 study enrolled mUC patients who had previously undergone platinum-containing chemotherapy during or after their disease progression, and were randomly assigned at a 1:1 ratio to receive intravenous infusion of atilizumab (1200 mg) or the chemotherapy regimen selected by the investigator (Changchun) Flunin 320 mg/m2, paclitaxel 175 mg/m2 or docetaxel 75 mg/m2), once every 3 weeks.
The previous main analysis showed that the OS of patients in the atelizumab group was not better than that of the chemotherapy group.
Based on this, the researchers conducted a long-term follow-up on the OS and safety of the intent-to-treat (ITT) population in the IMvigor211 study, and compared the therapeutic effects of atelizumab and chemotherapy over 2.
5 years after the start of treatment.
With a median follow-up of 33 months, the 24-month OS rate of the atelizumab group was 23%, while that of the chemotherapy group was only 13%.
In terms of safety, more patients in the chemotherapy group had grade 3/4 treatment-related adverse events (43% vs 22%) and adverse events leading to discontinuation (18% vs 9%).
More patients in the atilizumab group had adverse events of special concern (35% vs 20%), and most of these adverse events were grade 1-2.
In general, the safety results were consistent with the main analysis results, and no new safety signals were found.
03 New drug: Teriplizumab in the first-line treatment of esophageal squamous cell carcinoma phase III study was successful.
On April 22, Junshi issued an announcement stating that teriprizumab combined with paclitaxel/cisplatin was used to treat patients with advanced or metastatic esophageal squamous cell carcinoma The primary endpoint of the randomized, double-blind, placebo-controlled, multi-center Phase III clinical study (JUPITER-06) of JUPITER-06 meets the pre-specified superiority standard.
The JUPITER-06 study is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study, which aims to compare teriprizumab combined with paclitaxel/cisplatin and placebo combined with paclitaxel/cisplatin in advanced or metastatic Efficacy and safety of first-line treatment of esophageal squamous cell carcinoma.
The research was led by Professor Xu Ruihua from Sun Yat-sen University Cancer Hospital as the main investigator.
04 New drug: FDA has accelerated the approval of the first antibody conjugate drug targeting CD19 and has been approved for clinical trials in China.
ADC Therapeutics recently announced that the U.
S.
Food and Drug Administration (FDA) has accelerated the approval of CD19-targeted antibody couples.
The drug combination (ADC) Zynlonta (loncastuximab tesirine-lpyl) was launched as a single-drug treatment for adult patients with relapsed/refractory large B-cell lymphoma, and these patients have received at least two systemic therapies.
The press release stated that this is the first ADC that has been approved by the FDA to target CD19.
In China, according to the information on the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, the loncastuximab tesirine for injection jointly declared by ADC Therapeutics and Linglu Pharmaceuticals has obtained an implied license for a clinical trial and is expected to be linked with BTK inhibitors.
Used in Chinese patients to carry out clinical trials. References: [1]Qin S,Ren Z,Feng YH,et al.
Atezolizumab plus Bevacizumab versus Sorafenib in the Chinese Subpopulation with Unresectable Hepatocellular Carcinoma:Phase 3 Randomized,Open-Label IMbrave150 Study[J].
Liver Cancer.
Published online :April 23,2021.
[2]van der Heijden MS,Loriot Y,Durán I,et al.
Atezolizumab Versus Chemotherapy in Patients with Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma:A Long-term Overall Survival and Safety Update from the Phase 3 IMvigor211 Clinical Trial[J].
Eur Urol.
Published:April 23,2021.
DOI:https://doi.
org/10.
1016/j.
eururo.
2021.
03.
024[3]https://mp.
weixin.
qq .
com/s/Ps3UI286HGOSqUfDLvZuag[4]https://mp.
weixin.
qq.
com/s/fLsxjkt6JCNAiLyEAr35mA
On April 23, Liver Cancer reported IMbrave150 study Chinese subgroup data showed that for patients with unresectable hepatocellular carcinoma (HCC) who have not received systemic treatment, Compared with sorafenib, atelizumab + bevacizumab (hereinafter referred to as A+T) has clinically significant improvements in overall survival (OS) and progression-free survival (PFS).
This indicates that A+T may become a plan to change the treatment practice of patients with unresectable HCC in China.
The article cover screenshot IMbrave150 is a global, randomized, open-label, phase III study in unresectable HCC patients who have not received systemic treatment, including an extended study in mainland China.
In the study, patients were randomly assigned (2:1) to receive intravenous infusion of atilizumab 1200 mg + bevacizumab 15 mg/kg (every 3 weeks) or sorafenib 400 mg (every 3 weeks).
2 times a day).
Global research results show that compared with sorafenib, A+T significantly improves OS and PFS in patients with unresectable HCC.
The efficacy and safety results of the Chinese subgroup population in this report show that of the 194 Chinese patients included (137 in the global study and 57 in the China Extended Study), 133 received A+T treatment, and 61 received Sorafenib treatment.
At the time of the data cutoff, the stratified hazard ratio for OS was 0.
44 (95% CI 0.
25-0.
76), and PFS was 0.
60 (95% CI 0.
40-0.
90).
The median OS of the A+T group and the sorafenib group were unreached (NR; 95% CI 13.
5 months-NR) and 11.
4 months (95% CI 6.
7-NR), respectively, and the median PFS was 5.
7 Months (95% CI 4.
2-8.
3) and 3.
2 months (95% CI 2.
6-4.
8).
In terms of safety, the incidence of grade 3-4 adverse events in the A+T group was 59.
1% (78/132), and that in the sorafenib group was 46.
6% (27/58).
The most common grade 3-4 adverse event in the A+T group was hypertension (15.
2%), but other high-grade adverse events were rare.
The researchers pointed out that compared with sorafenib, A+T achieved clinically significant improvements in OS and PFS.
Therefore, for Chinese patients with unresectable HCC, A+T should be regarded as a treatment that changes practice.
02Eur Urol: Atelizumab can provide long-term remission for patients with locally advanced or metastatic urothelial cancer who have received platinum-containing treatment.
On April 23, European Urology reported the OS and safety update data of the phase III IMvigor211 study .
The results show that for patients with locally advanced or metastatic urothelial carcinoma (mUC) who have received platinum-containing treatment, atelizumab treatment can achieve long-term and lasting remission with controllable safety.
Article cover screenshot IMvigor211 study enrolled mUC patients who had previously undergone platinum-containing chemotherapy during or after their disease progression, and were randomly assigned at a 1:1 ratio to receive intravenous infusion of atilizumab (1200 mg) or the chemotherapy regimen selected by the investigator (Changchun) Flunin 320 mg/m2, paclitaxel 175 mg/m2 or docetaxel 75 mg/m2), once every 3 weeks.
The previous main analysis showed that the OS of patients in the atelizumab group was not better than that of the chemotherapy group.
Based on this, the researchers conducted a long-term follow-up on the OS and safety of the intent-to-treat (ITT) population in the IMvigor211 study, and compared the therapeutic effects of atelizumab and chemotherapy over 2.
5 years after the start of treatment.
With a median follow-up of 33 months, the 24-month OS rate of the atelizumab group was 23%, while that of the chemotherapy group was only 13%.
In terms of safety, more patients in the chemotherapy group had grade 3/4 treatment-related adverse events (43% vs 22%) and adverse events leading to discontinuation (18% vs 9%).
More patients in the atilizumab group had adverse events of special concern (35% vs 20%), and most of these adverse events were grade 1-2.
In general, the safety results were consistent with the main analysis results, and no new safety signals were found.
03 New drug: Teriplizumab in the first-line treatment of esophageal squamous cell carcinoma phase III study was successful.
On April 22, Junshi issued an announcement stating that teriprizumab combined with paclitaxel/cisplatin was used to treat patients with advanced or metastatic esophageal squamous cell carcinoma The primary endpoint of the randomized, double-blind, placebo-controlled, multi-center Phase III clinical study (JUPITER-06) of JUPITER-06 meets the pre-specified superiority standard.
The JUPITER-06 study is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study, which aims to compare teriprizumab combined with paclitaxel/cisplatin and placebo combined with paclitaxel/cisplatin in advanced or metastatic Efficacy and safety of first-line treatment of esophageal squamous cell carcinoma.
The research was led by Professor Xu Ruihua from Sun Yat-sen University Cancer Hospital as the main investigator.
04 New drug: FDA has accelerated the approval of the first antibody conjugate drug targeting CD19 and has been approved for clinical trials in China.
ADC Therapeutics recently announced that the U.
S.
Food and Drug Administration (FDA) has accelerated the approval of CD19-targeted antibody couples.
The drug combination (ADC) Zynlonta (loncastuximab tesirine-lpyl) was launched as a single-drug treatment for adult patients with relapsed/refractory large B-cell lymphoma, and these patients have received at least two systemic therapies.
The press release stated that this is the first ADC that has been approved by the FDA to target CD19.
In China, according to the information on the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, the loncastuximab tesirine for injection jointly declared by ADC Therapeutics and Linglu Pharmaceuticals has obtained an implied license for a clinical trial and is expected to be linked with BTK inhibitors.
Used in Chinese patients to carry out clinical trials. References: [1]Qin S,Ren Z,Feng YH,et al.
Atezolizumab plus Bevacizumab versus Sorafenib in the Chinese Subpopulation with Unresectable Hepatocellular Carcinoma:Phase 3 Randomized,Open-Label IMbrave150 Study[J].
Liver Cancer.
Published online :April 23,2021.
[2]van der Heijden MS,Loriot Y,Durán I,et al.
Atezolizumab Versus Chemotherapy in Patients with Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma:A Long-term Overall Survival and Safety Update from the Phase 3 IMvigor211 Clinical Trial[J].
Eur Urol.
Published:April 23,2021.
DOI:https://doi.
org/10.
1016/j.
eururo.
2021.
03.
024[3]https://mp.
weixin.
qq .
com/s/Ps3UI286HGOSqUfDLvZuag[4]https://mp.
weixin.
qq.
com/s/fLsxjkt6JCNAiLyEAr35mA
