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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 document, you can add the editor WeChat yxj_oncology to get it) Key points: Naturemedicine: The results of the interim analysis of domestic CDK4/6 inhibitors are released! JAMAOncology: As elderly cancer patients get older, it will be more common to stop the drug due to adverse immune reactions.
New drugs: PD-L1 inhibitors that can be injected subcutaneously are about to be approved! New drug: Roche CD20/CD3 bispecific antibody starts clinical trial in China 01 Naturemedicine: Interim analysis results of domestic CDK4/6 inhibitors are released! Blocking the cyclin-dependent kinase 4 and 6 pathways has been shown to be effective in treating hormone receptor-positive advanced breast cancer (ABC)
.
This study reports the interim results of DAWNA-1 (NCT03927456), a double-blind, randomized, phase III trial that evaluated dapicillide in hormone receptor-positive and HER2-negative ABC patients with disease progression after endocrine therapy ( The efficacy and safety of a CDK4/6 inhibitor) combined with Fulvestrant
.
The results of the study support Dapiciride combined with Fulvestrant as a new treatment option for pre-treatment of hormone receptor-positive and HER2-negative ABC
.
Screenshot of the official website.
The study reached the primary endpoint, showing that compared with placebo and fulvestrant, the researcher-assessed progression-free survival (PFS) significantly prolonged (HR0.
42, 95%CI0).
.
31-0.
58; one-sided P<0.
0001)
.
The most common grade 3 or 4 adverse events of dapiciride + fulvestrant were neutropenia (84.
2%) and leukopenia (62.
1%)
.
The incidence of serious adverse events for dapicilide + fulvestrant and placebo + fulvestrant were 5.
8% and 6.
7%, respectively
.
02JAMAOncology: As elderly cancer patients age, it is more common to discontinue the drug due to adverse immune reactions.
The representation of middle-aged and elderly patients (age ≥80 years old) in cancer clinical trials has historically been low.
Regarding immune checkpoint inhibitors (ICI) in elderly patients Little is known about the efficacy of it
.
These drugs are associated with immune-related adverse events (irAE) and may be particularly relevant to the incidence of this population
.
This study aims to understand the clinical outcome and safety of ICI in elderly cancer patients (age ≥ 80 years)
.
The results of the study show that ICI therapy may be effective and is generally well tolerated in elderly cancer patients, although ICI withdrawal due to irAE is more common with increasing age
.
Screenshot from the official website This study conducted a retrospective study of 928 elderly patients with different tumors who received single-agent ICI treatment at 18 academic centers in the United States and Europe from 2010 to 2019
.
The main outcome and indicators are the clinical outcome and irAE pattern of elderly patients receiving single-agent ICI therapy
.
The results of the study showed that in the entire cohort, the three most common tumors were non-small cell lung cancer (NSCLC, 37.
2%), melanoma (35.
5%) and genitourinary system (GU) tumors (16.
5%)
.
The objective response rates of patients with NSCLC, melanoma, and GU tumors were 32.
2%, 39.
3%, and 26.
2%, respectively
.
The median PFS and overall survival (OS) were 6.
7 and 10.
9 months (NSCLC), 11.
1 and 30.
0 months (melanoma), and 6.
0 and 15.
0 months (GU), respectively
.
Within the histologically specific subgroups (NSCLC, melanoma, and GU), the clinical outcomes of each age subgroup were similar (age <85 years vs.
≥85 years)
.
Among all 928 patients, 383 (41.
3%) had ≥1 irAE, of which 113 (12.
2%) were reported as grade 3-4 (G)
.
The median time to irAE occurrence was 9.
8 weeks; 219 cases (57%) occurred within the first 3 months after the onset of ICI
.
137 patients (16.
1%) stopped ICI treatment due to irAE
.
There was no statistically significant difference in the incidence of irAE among patients younger than 85, 85-89 and 90 years and older
.
03New drug: PD-L1 inhibitor that can be injected subcutaneously is about to be approved! According to the latest announcement by the National Medical Products Administration (NMPA), Corning Jereh has reached strategic cooperation with Sidi Medicine and Simcere Pharmaceuticals.
The new biological drug Envolimab Injection (KN035) has entered into the market application: Approval
.
This means that this recombinant humanized anti-PD-L1 single domain antibody that can be injected subcutaneously is expected to be approved in China in the near future
.
Screenshot of the official website 04 New drug: Roche CD20/CD3 bispecific antibody launched clinical trial registration and information disclosure platform in China.
Roche has launched a RO7030816 (mosunetuzumab) treatment in China for relapsed or refractory filtration.
Phase I clinical study in patients with alveolar lymphoma
.
Public information shows that mosunetuzumab is a bispecific antibody that targets CD20 and CD3 under development
.
According to a recent press release issued by Roche, mosunetuzumab is expected to submit a regulatory application overseas by the end of this year
.
References: [1]Xu, B.
, Zhang, Q.
, Zhang, P.
et al.
Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial.
Nat Med (2021).
https://doi.
org/10.
1038/s41591-021-01562-9; https:// CA, Cortellini A, Ma W, et al.
Clinical Outcomes and Toxic Effects of Single-Agent Immune Checkpoint Inhibitors Among Patients Aged 80 Years or Older With Cancer: A Multicenter International Cohort Study.
JAMA Oncol.
Published online November 04, 2021.
doi:10.
1001/jamaoncol.
2021.
4960; https://jamanetwork.
com/journals/jamaoncology/article-abstract/2785698[3]https://mp.
weixin.
qq.
com/s/-O9xHTFgsaf4v8L7xKkXWw[4]https://mp.
weixin.
qq .
com/s/I6QBDYCyvZ7EGwrrn5gUSg
New drugs: PD-L1 inhibitors that can be injected subcutaneously are about to be approved! New drug: Roche CD20/CD3 bispecific antibody starts clinical trial in China 01 Naturemedicine: Interim analysis results of domestic CDK4/6 inhibitors are released! Blocking the cyclin-dependent kinase 4 and 6 pathways has been shown to be effective in treating hormone receptor-positive advanced breast cancer (ABC)
.
This study reports the interim results of DAWNA-1 (NCT03927456), a double-blind, randomized, phase III trial that evaluated dapicillide in hormone receptor-positive and HER2-negative ABC patients with disease progression after endocrine therapy ( The efficacy and safety of a CDK4/6 inhibitor) combined with Fulvestrant
.
The results of the study support Dapiciride combined with Fulvestrant as a new treatment option for pre-treatment of hormone receptor-positive and HER2-negative ABC
.
Screenshot of the official website.
The study reached the primary endpoint, showing that compared with placebo and fulvestrant, the researcher-assessed progression-free survival (PFS) significantly prolonged (HR0.
42, 95%CI0).
.
31-0.
58; one-sided P<0.
0001)
.
The most common grade 3 or 4 adverse events of dapiciride + fulvestrant were neutropenia (84.
2%) and leukopenia (62.
1%)
.
The incidence of serious adverse events for dapicilide + fulvestrant and placebo + fulvestrant were 5.
8% and 6.
7%, respectively
.
02JAMAOncology: As elderly cancer patients age, it is more common to discontinue the drug due to adverse immune reactions.
The representation of middle-aged and elderly patients (age ≥80 years old) in cancer clinical trials has historically been low.
Regarding immune checkpoint inhibitors (ICI) in elderly patients Little is known about the efficacy of it
.
These drugs are associated with immune-related adverse events (irAE) and may be particularly relevant to the incidence of this population
.
This study aims to understand the clinical outcome and safety of ICI in elderly cancer patients (age ≥ 80 years)
.
The results of the study show that ICI therapy may be effective and is generally well tolerated in elderly cancer patients, although ICI withdrawal due to irAE is more common with increasing age
.
Screenshot from the official website This study conducted a retrospective study of 928 elderly patients with different tumors who received single-agent ICI treatment at 18 academic centers in the United States and Europe from 2010 to 2019
.
The main outcome and indicators are the clinical outcome and irAE pattern of elderly patients receiving single-agent ICI therapy
.
The results of the study showed that in the entire cohort, the three most common tumors were non-small cell lung cancer (NSCLC, 37.
2%), melanoma (35.
5%) and genitourinary system (GU) tumors (16.
5%)
.
The objective response rates of patients with NSCLC, melanoma, and GU tumors were 32.
2%, 39.
3%, and 26.
2%, respectively
.
The median PFS and overall survival (OS) were 6.
7 and 10.
9 months (NSCLC), 11.
1 and 30.
0 months (melanoma), and 6.
0 and 15.
0 months (GU), respectively
.
Within the histologically specific subgroups (NSCLC, melanoma, and GU), the clinical outcomes of each age subgroup were similar (age <85 years vs.
≥85 years)
.
Among all 928 patients, 383 (41.
3%) had ≥1 irAE, of which 113 (12.
2%) were reported as grade 3-4 (G)
.
The median time to irAE occurrence was 9.
8 weeks; 219 cases (57%) occurred within the first 3 months after the onset of ICI
.
137 patients (16.
1%) stopped ICI treatment due to irAE
.
There was no statistically significant difference in the incidence of irAE among patients younger than 85, 85-89 and 90 years and older
.
03New drug: PD-L1 inhibitor that can be injected subcutaneously is about to be approved! According to the latest announcement by the National Medical Products Administration (NMPA), Corning Jereh has reached strategic cooperation with Sidi Medicine and Simcere Pharmaceuticals.
The new biological drug Envolimab Injection (KN035) has entered into the market application: Approval
.
This means that this recombinant humanized anti-PD-L1 single domain antibody that can be injected subcutaneously is expected to be approved in China in the near future
.
Screenshot of the official website 04 New drug: Roche CD20/CD3 bispecific antibody launched clinical trial registration and information disclosure platform in China.
Roche has launched a RO7030816 (mosunetuzumab) treatment in China for relapsed or refractory filtration.
Phase I clinical study in patients with alveolar lymphoma
.
Public information shows that mosunetuzumab is a bispecific antibody that targets CD20 and CD3 under development
.
According to a recent press release issued by Roche, mosunetuzumab is expected to submit a regulatory application overseas by the end of this year
.
References: [1]Xu, B.
, Zhang, Q.
, Zhang, P.
et al.
Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial.
Nat Med (2021).
https://doi.
org/10.
1038/s41591-021-01562-9; https:// CA, Cortellini A, Ma W, et al.
Clinical Outcomes and Toxic Effects of Single-Agent Immune Checkpoint Inhibitors Among Patients Aged 80 Years or Older With Cancer: A Multicenter International Cohort Study.
JAMA Oncol.
Published online November 04, 2021.
doi:10.
1001/jamaoncol.
2021.
4960; https://jamanetwork.
com/journals/jamaoncology/article-abstract/2785698[3]https://mp.
weixin.
qq.
com/s/-O9xHTFgsaf4v8L7xKkXWw[4]https://mp.
weixin.
qq .
com/s/I6QBDYCyvZ7EGwrrn5gUSg
