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*Only for medical professionals to read and reference for 1 minute a day, to give you professional "talks" in the tumor circle! (If you want the original text of the document, you can add Xiaobian WeChat yxj_oncology to get it) Key tips Lancet Oncol: O drug + chemotherapy significantly improves progression-free survival in patients with gastric or gastroesophageal junction cancer Lancet Oncol: FGFR-TKI in patients with advanced urothelial cancer New drug showing activity and controllable safety in China: The domestic multi-target TKI voronib has been accepted for marketing.
Progression-free survival of patients with gastroesophageal junction cancer The antitumor effect of immune checkpoint inhibitors combined with oxaliplatin-based chemotherapy has been reported
.
On January 11, a study investigating the efficacy of nivolumab + chemotherapy (oxaliplatin-based) versus placebo + chemotherapy in first-line treatment of patients with HER2-negative, unresectable advanced or recurrent gastric or gastroesophageal junction cancer Published in Lancet Oncol
.
The results showed that combination therapy significantly improved PFS in treatment-naïve patients, but not overall survival (OS)
.
Screenshot of the journal's official website The ATTRACTION-4 study is a randomized, double-blind, controlled Phase II-III trial conducted at 130 centers in Japan, South Korea, and Taiwan, recruiting treatment-naïve, HER2-negative, unresectable patients aged 20 and older.
Advanced or recurrent gastric or gastroesophageal junction cancer (any PD-L1 expression level) with at least one measurable lesion as assessed by RECIST v1.
1 and a baseline ECOG of 0 or 1
.
Patients were randomly assigned (1:1) to receive chemotherapy (every 3 weeks, oxaliplatin 130 mg/m2 on day 1 plus oral S-1 40 mg/m2 or capecitabine 1000 mg/m2 on days 1-14 twice daily) in combination with nivolumab (360 mg IV every 3 weeks) or placebo
.
The primary endpoints were PFS and OS in the intent-to-treat population, and safety was assessed in all patients who received at least one dose of the indicated treatment
.
724 patients were randomly assigned to receive nivolumab plus chemotherapy (n=362) or placebo plus chemotherapy (n=362)
.
At the interim analysis (median follow-up, 11.
6 months), median PFS was 10.
45 months (95% CI 8.
44–14.
75 months) in the combination arm and 8.
34 months (95% CI 6.
97–9.
40 months) in the placebo arm month) (HR 0.
68; 98.
51%CI 0.
51–0.
90; p=0.
0007)
.
At the final analysis (median follow-up 26.
6 months), median OS was 17.
45 months (95% CI 15.
67–20.
83 months) in the combination arm and 17.
15 months (95% CI 15.
18–19.
65 months) in the placebo arm month) (HR 0.
90; 95%CI 0.
75–1.
08; p=0.
26)
.
The most common treatment-related grade 3-4 adverse events were neutropenia (71, 20% vs 57, 16%) and platelet count (34, 9% vs 33, 9%)
.
Treatment-related serious adverse events of any grade were observed in 88 (25%) patients in the combination group and 51 (14%) in the placebo group, the most common of which was decreased appetite (18, 5% vs 10, 3%).
)
.
Six treatment-related deaths occurred: 3 in the nivolumab plus chemotherapy group (1 each for febrile neutropenia, liver failure, and sudden death) and 3 in the placebo group (sepsis, hemolytic anemia, and interstitial Lancet Oncol: FGFR-TKI Shows Activity and Controllable Safety in Patients with Advanced Urothelial Carcinoma Erdafitinib is a pan-fibroblast growth factor receptor tyrosine kinase inhibitor (FGFR-TKI) ), a preliminary analysis of the previous BLC2001 study found that erdafitinib was clinically active and tolerable in patients with advanced urothelial carcinoma and FGFR mutations
.
The final analysis of the BLC2001 study was recently published in Lancet Oncol
.
The results showed that erdafitinib showed consistent activity and manageable safety profile in patients with locally advanced or metastatic urothelial carcinoma and FGFR mutations with extended follow-up
.
The BLC2001 phase II study was conducted at 126 medical centers in 14 countries in Asia, Europe, and North America, and enrolled patients 18 years of age and older with unresectable locally advanced or metastatic urothelial carcinoma with at least one prespecified FGFR mutation, ECOG score 0-2, and progression after at least one systemic chemotherapy or within 12 months of neoadjuvant/adjuvant chemotherapy, or ineligible for cisplatin
.
The primary endpoint was investigator-assessed objective response rate (ORR) according to RECIST v1.
1, and efficacy and safety were analyzed in all patients who had received at least one dose of erdafitinib
.
Between May 25, 2015, and August 9, 2018, 212 patients were enrolled, of whom 101 received erdafitinib 8 mg/day UpT, with a median follow-up of 24.
0 months (IQR 22.
7–26.
6)
.
The results showed that the objective response rate of erdafitinib treatment was 40% (95% CI 30%-49%)
.
The safety profile was similar to the initial analysis, with no new safety signals reported
.
Grade 3-4 treatment-related adverse events occurred in 72 of 101 patients (71%), the most common of which were stomatitis (14, 14%) and hyponatremia (11, 11%), no Treatment-related deaths
.
03The domestic multi-target TKI voronib marketing application was accepted Recently, the official website of the Center for Drug Evaluation (CDE) of the State Drug Administration of China shows that Betta Pharmaceuticals has submitted a marketing application for a class 1 new drug, voronib tablets.
Get accepted
.
The indication for its NDA submission this time is presumed to be combined with everolimus for the treatment of patients with advanced renal cancer
.
Voronib is a new generation of multi-target TKI, which simultaneously targets VEGFR, PDGFR, c-Kit, Flt-3, CSF1R and other multi-targets, and has anti-angiogenic effects
.
04The first domestic anti-CD20 monoclonal antibody zebetuzumab applied for listing On January 11, the CDE official website showed that the application for listing of the first-class innovative CD20 monoclonal antibody zebetuzumab independently developed by Borui Bio/Hisun Bio was accepted.
.
Indications: for the initial treatment of CD20 positive diffuse large B-cell lymphoma (DLBCL)
.
References: 1.
Kang YK, et al.
The Lancet Oncology.
2022 Jan 11.
DOI: https://doi.
org/10.
1016/S1470-2045(21)00692-6 https:// /lanonc/article/PIIS1470-2045(21)00692-6/fulltext2.
Siefker-Radtke AO, et al.
The Lancet Oncology.
2022 Jan 11.
DOI: https://doi.
org/10.
1016/S1470-2045(21 )00660-4.
https:// .
https://mp.
weixin.
qq.
com/s/N35Q9EVWtSPQKWfWjihyHQ
Progression-free survival of patients with gastroesophageal junction cancer The antitumor effect of immune checkpoint inhibitors combined with oxaliplatin-based chemotherapy has been reported
.
On January 11, a study investigating the efficacy of nivolumab + chemotherapy (oxaliplatin-based) versus placebo + chemotherapy in first-line treatment of patients with HER2-negative, unresectable advanced or recurrent gastric or gastroesophageal junction cancer Published in Lancet Oncol
.
The results showed that combination therapy significantly improved PFS in treatment-naïve patients, but not overall survival (OS)
.
Screenshot of the journal's official website The ATTRACTION-4 study is a randomized, double-blind, controlled Phase II-III trial conducted at 130 centers in Japan, South Korea, and Taiwan, recruiting treatment-naïve, HER2-negative, unresectable patients aged 20 and older.
Advanced or recurrent gastric or gastroesophageal junction cancer (any PD-L1 expression level) with at least one measurable lesion as assessed by RECIST v1.
1 and a baseline ECOG of 0 or 1
.
Patients were randomly assigned (1:1) to receive chemotherapy (every 3 weeks, oxaliplatin 130 mg/m2 on day 1 plus oral S-1 40 mg/m2 or capecitabine 1000 mg/m2 on days 1-14 twice daily) in combination with nivolumab (360 mg IV every 3 weeks) or placebo
.
The primary endpoints were PFS and OS in the intent-to-treat population, and safety was assessed in all patients who received at least one dose of the indicated treatment
.
724 patients were randomly assigned to receive nivolumab plus chemotherapy (n=362) or placebo plus chemotherapy (n=362)
.
At the interim analysis (median follow-up, 11.
6 months), median PFS was 10.
45 months (95% CI 8.
44–14.
75 months) in the combination arm and 8.
34 months (95% CI 6.
97–9.
40 months) in the placebo arm month) (HR 0.
68; 98.
51%CI 0.
51–0.
90; p=0.
0007)
.
At the final analysis (median follow-up 26.
6 months), median OS was 17.
45 months (95% CI 15.
67–20.
83 months) in the combination arm and 17.
15 months (95% CI 15.
18–19.
65 months) in the placebo arm month) (HR 0.
90; 95%CI 0.
75–1.
08; p=0.
26)
.
The most common treatment-related grade 3-4 adverse events were neutropenia (71, 20% vs 57, 16%) and platelet count (34, 9% vs 33, 9%)
.
Treatment-related serious adverse events of any grade were observed in 88 (25%) patients in the combination group and 51 (14%) in the placebo group, the most common of which was decreased appetite (18, 5% vs 10, 3%).
)
.
Six treatment-related deaths occurred: 3 in the nivolumab plus chemotherapy group (1 each for febrile neutropenia, liver failure, and sudden death) and 3 in the placebo group (sepsis, hemolytic anemia, and interstitial Lancet Oncol: FGFR-TKI Shows Activity and Controllable Safety in Patients with Advanced Urothelial Carcinoma Erdafitinib is a pan-fibroblast growth factor receptor tyrosine kinase inhibitor (FGFR-TKI) ), a preliminary analysis of the previous BLC2001 study found that erdafitinib was clinically active and tolerable in patients with advanced urothelial carcinoma and FGFR mutations
.
The final analysis of the BLC2001 study was recently published in Lancet Oncol
.
The results showed that erdafitinib showed consistent activity and manageable safety profile in patients with locally advanced or metastatic urothelial carcinoma and FGFR mutations with extended follow-up
.
The BLC2001 phase II study was conducted at 126 medical centers in 14 countries in Asia, Europe, and North America, and enrolled patients 18 years of age and older with unresectable locally advanced or metastatic urothelial carcinoma with at least one prespecified FGFR mutation, ECOG score 0-2, and progression after at least one systemic chemotherapy or within 12 months of neoadjuvant/adjuvant chemotherapy, or ineligible for cisplatin
.
The primary endpoint was investigator-assessed objective response rate (ORR) according to RECIST v1.
1, and efficacy and safety were analyzed in all patients who had received at least one dose of erdafitinib
.
Between May 25, 2015, and August 9, 2018, 212 patients were enrolled, of whom 101 received erdafitinib 8 mg/day UpT, with a median follow-up of 24.
0 months (IQR 22.
7–26.
6)
.
The results showed that the objective response rate of erdafitinib treatment was 40% (95% CI 30%-49%)
.
The safety profile was similar to the initial analysis, with no new safety signals reported
.
Grade 3-4 treatment-related adverse events occurred in 72 of 101 patients (71%), the most common of which were stomatitis (14, 14%) and hyponatremia (11, 11%), no Treatment-related deaths
.
03The domestic multi-target TKI voronib marketing application was accepted Recently, the official website of the Center for Drug Evaluation (CDE) of the State Drug Administration of China shows that Betta Pharmaceuticals has submitted a marketing application for a class 1 new drug, voronib tablets.
Get accepted
.
The indication for its NDA submission this time is presumed to be combined with everolimus for the treatment of patients with advanced renal cancer
.
Voronib is a new generation of multi-target TKI, which simultaneously targets VEGFR, PDGFR, c-Kit, Flt-3, CSF1R and other multi-targets, and has anti-angiogenic effects
.
04The first domestic anti-CD20 monoclonal antibody zebetuzumab applied for listing On January 11, the CDE official website showed that the application for listing of the first-class innovative CD20 monoclonal antibody zebetuzumab independently developed by Borui Bio/Hisun Bio was accepted.
.
Indications: for the initial treatment of CD20 positive diffuse large B-cell lymphoma (DLBCL)
.
References: 1.
Kang YK, et al.
The Lancet Oncology.
2022 Jan 11.
DOI: https://doi.
org/10.
1016/S1470-2045(21)00692-6 https:// /lanonc/article/PIIS1470-2045(21)00692-6/fulltext2.
Siefker-Radtke AO, et al.
The Lancet Oncology.
2022 Jan 11.
DOI: https://doi.
org/10.
1016/S1470-2045(21 )00660-4.
https:// .
https://mp.
weixin.
qq.
com/s/N35Q9EVWtSPQKWfWjihyHQ
