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▎Editor of WuXi AppTec's content team On November 24, 2021, HUTCHMED and AstraZeneca announced that they have launched a phase 3 clinical trial in China
.
The trial will be carried out in lung cancer patients with EGFR and MET mutations or abnormalities who have relapsed after receiving EGFR inhibitor treatment, and aims to evaluate highly selective and potent oral mesenchymal transition factor (MET) tyrosine kinase inhibitors (TKI) Orpathys, the efficacy and safety of the combination with AstraZeneca’s third-generation irreversible epidermal growth factor receptor (EGFR) TKI Tagrisso
.
The trial has completed the first patient administration on November 22, 2021
.
Lung cancer accounts for about one-fifth of all cancer deaths
.
The number of lung cancer patients in China accounts for more than one-third of the total number of lung cancer patients in the world
.
Lung cancer is usually divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which 80-85% are NSCLC
.
Among Asian NSCLC patients, about 30-40% have EGFR mutations, and these patients are particularly sensitive to EGFR-TKI treatment
.
As an irreversible third-generation EGFR-TKI, Teresa can inhibit both EGFR sensitive mutations and EGFR-T790M resistant mutations, and has clinical effects on metastatic lesions in the central nervous system
.
This inhibitor can block the signal transduction pathways that drive tumor cell growth
.
In China, Teresa was first approved as a second-line treatment for patients with EGFR-T790M mutation-positive advanced NSCLC in March 2017, and was approved as a first-line treatment for patients with EGFR mutation-positive advanced NSCLC in October 2019
.
At present, Teresa has been approved for listing in more than 80 countries and regions around the world
.
And MET is a receptor tyrosine kinase
.
MET amplification or overexpression can not only appear in untreated NSCLC patients, but also is one of the main mechanisms of acquired drug resistance after EGFR-mutated metastatic NSCLC patients receive EGFR-TKI treatment
.
Waresa is a potent and highly selective oral MET-TKI, which shows positive clinical activity in advanced solid tumors
.
Waresa can block the abnormal activation of the MET receptor tyrosine kinase signaling pathway caused by mutations (such as exon 14 jumping mutations or other point mutations) or gene amplification
.
Waresa has been approved for marketing in China for the treatment of NSCLC patients with MET exon 14 jumping mutations who have undergone disease progression after receiving systemic therapy or cannot receive chemotherapy
.
Currently, Waresa is being developed as a monotherapy or a combination therapy with other drugs for the treatment of multiple tumor types including lung cancer, kidney cancer and gastric cancer
.
Image source: 123RF This open-label, randomized controlled, multi-center phase 3 clinical trial will be carried out in locally advanced or metastatic NSCLC with disease progression and MET amplification after receiving EGFR inhibitor treatment.
The efficacy and safety of combination therapy of Teresa and Waresa versus platinum-based dual-drug chemotherapy (the current standard therapy) will be evaluated
.
The primary endpoint of the study is the median progression-free survival (PFS) assessed by the investigator
.
Other endpoints include median PFS, median overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and time to disease response (TTR) assessed by the independent review board And safety
.
References: [1] HUTCHMED and AstraZeneca Initiate SACHI Phase III Trial of ORPATHYS® and TAGRISSO® Combination in Certain Lung Cancer Patients in China After Progression on EGFR Inhibitor Therapy.
Retrieved November 23, from https:// news-release/2021/11/24/2340238/0/en/HUTCHMED-and-AstraZeneca-Initiate-SACHI-Phase-III-Trial-of-ORPATHYS-and-TAGRISSO-Combination-in-Certain-Lung-Cancer- Patients-in-China-After-Progression-on-EGFR-Inhibitor-Therapy.
html[2] Hutchison Medicine and AstraZeneca initiate combined therapy treatment with ORPATHYS® (ORPATHYS®) and Teresa® (TAGRISSO®) SACHI China Phase III clinical trial of specific lung cancer patients with disease progression after EGFR inhibitor treatment.
Retrieved November 24, 2021, from https:// Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
.
The trial will be carried out in lung cancer patients with EGFR and MET mutations or abnormalities who have relapsed after receiving EGFR inhibitor treatment, and aims to evaluate highly selective and potent oral mesenchymal transition factor (MET) tyrosine kinase inhibitors (TKI) Orpathys, the efficacy and safety of the combination with AstraZeneca’s third-generation irreversible epidermal growth factor receptor (EGFR) TKI Tagrisso
.
The trial has completed the first patient administration on November 22, 2021
.
Lung cancer accounts for about one-fifth of all cancer deaths
.
The number of lung cancer patients in China accounts for more than one-third of the total number of lung cancer patients in the world
.
Lung cancer is usually divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which 80-85% are NSCLC
.
Among Asian NSCLC patients, about 30-40% have EGFR mutations, and these patients are particularly sensitive to EGFR-TKI treatment
.
As an irreversible third-generation EGFR-TKI, Teresa can inhibit both EGFR sensitive mutations and EGFR-T790M resistant mutations, and has clinical effects on metastatic lesions in the central nervous system
.
This inhibitor can block the signal transduction pathways that drive tumor cell growth
.
In China, Teresa was first approved as a second-line treatment for patients with EGFR-T790M mutation-positive advanced NSCLC in March 2017, and was approved as a first-line treatment for patients with EGFR mutation-positive advanced NSCLC in October 2019
.
At present, Teresa has been approved for listing in more than 80 countries and regions around the world
.
And MET is a receptor tyrosine kinase
.
MET amplification or overexpression can not only appear in untreated NSCLC patients, but also is one of the main mechanisms of acquired drug resistance after EGFR-mutated metastatic NSCLC patients receive EGFR-TKI treatment
.
Waresa is a potent and highly selective oral MET-TKI, which shows positive clinical activity in advanced solid tumors
.
Waresa can block the abnormal activation of the MET receptor tyrosine kinase signaling pathway caused by mutations (such as exon 14 jumping mutations or other point mutations) or gene amplification
.
Waresa has been approved for marketing in China for the treatment of NSCLC patients with MET exon 14 jumping mutations who have undergone disease progression after receiving systemic therapy or cannot receive chemotherapy
.
Currently, Waresa is being developed as a monotherapy or a combination therapy with other drugs for the treatment of multiple tumor types including lung cancer, kidney cancer and gastric cancer
.
Image source: 123RF This open-label, randomized controlled, multi-center phase 3 clinical trial will be carried out in locally advanced or metastatic NSCLC with disease progression and MET amplification after receiving EGFR inhibitor treatment.
The efficacy and safety of combination therapy of Teresa and Waresa versus platinum-based dual-drug chemotherapy (the current standard therapy) will be evaluated
.
The primary endpoint of the study is the median progression-free survival (PFS) assessed by the investigator
.
Other endpoints include median PFS, median overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and time to disease response (TTR) assessed by the independent review board And safety
.
References: [1] HUTCHMED and AstraZeneca Initiate SACHI Phase III Trial of ORPATHYS® and TAGRISSO® Combination in Certain Lung Cancer Patients in China After Progression on EGFR Inhibitor Therapy.
Retrieved November 23, from https:// news-release/2021/11/24/2340238/0/en/HUTCHMED-and-AstraZeneca-Initiate-SACHI-Phase-III-Trial-of-ORPATHYS-and-TAGRISSO-Combination-in-Certain-Lung-Cancer- Patients-in-China-After-Progression-on-EGFR-Inhibitor-Therapy.
html[2] Hutchison Medicine and AstraZeneca initiate combined therapy treatment with ORPATHYS® (ORPATHYS®) and Teresa® (TAGRISSO®) SACHI China Phase III clinical trial of specific lung cancer patients with disease progression after EGFR inhibitor treatment.
Retrieved November 24, 2021, from https:// Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
