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▎The content team editor of WuXi AppTec today, Amgen announced at the ASCO annual meeting the latest results of its ongoing anti-FGFR2b monoclonal antibody therapy bemarituzumab in a phase 2 clinical trial
.
The test results showed that at a median follow-up time of 12.
5 months, the median overall survival (OS) of patients with FGFR2b positive and HER2-negative gastric cancer or gastroesophageal junction cancer (GEJ) who received bemarituzumab and chemotherapy first-line treatment was 19.
2 Month, this value in the chemotherapy group was 13.
5 months (n=155, HR=0.
6, 95% CI: 0.
38, 0.
94)
.
Adding bemarituzumab extended the patient's median OS by 5.
7 months
.
Gastric cancer is the fourth leading cause of cancer deaths in the world.
More than 1 million new gastric cancer patients are diagnosed each year, and its incidence is particularly high in Asia
.
About 80-85% of patients with advanced gastric cancer and GEJ cancer are HER2 negative, and about 30% of them overexpress FGFR2b
.
Bemarituzumab is a monoclonal antibody against FGFR2b
.
It has a dual mechanism of action.
It can not only block the signal transduction of growth factors mediated by FGFR2b by binding to FGFR2b, but also kill cancer cells through antibody-dependent cell-mediated cytotoxicity (ADCC)
.
It received the breakthrough therapy designation granted by the FDA in April this year
.
Zai Lab has the development rights of this innovative therapy in Greater China and is responsible for the clinical trials of the drug in Greater China
.
▲The mechanism of action of bemarituzumab (picture source: Five Prime's official website) In this phase 2 clinical trial, the combination therapy of bemarituzumab has a more prominent effect on the subgroup of patients with >10% of tumor cells overexpressing FGFR2b.
This subgroup of patients The median OS was 25.
4 months, while the control group value was 11.
1 months (n=96, HR: 0.
41; 95% CI: 0.
23, 0.
74)
.
In terms of safety, the number of adverse events in the bemarituzumab+ chemotherapy group (100%) and the chemotherapy group (98.
7%) was close
.
The incidence of adverse corneal events in the Bemarituzumab+ chemotherapy group (67.
1%) was higher than that in the chemotherapy group (10.
4%).
Dry eye symptoms were the most common corneal adverse events, and most corneal adverse events were reversible
.
Dr.
David M.
Reese, Executive Vice President of Research and Development of Amgen, said: "These latest results demonstrate the clinical benefits of bemarituzumab+chemotherapy combination for patients.
We look forward to advancing bemarituzumab to the phase 3 clinical development stage
.
"Reference: [1] Phase 2 Fight Trial Continues To Show Improved Overall Survival With Bemarituzumab Plus Chemotherapy In Patients With FGFR2b+ Gastric And Gastroesophageal Cancers.
Retrieved June 4, 2021, from https:// -releases/2021/06/phase-2-fight-trial-continues-to-show-improved-overall-survival-with-bemarituzumab-plus-chemotherapy-in-patients-with-fgfr2b-gastric-and-gastroesophageal-cancers Note: This article is intended to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
.
The test results showed that at a median follow-up time of 12.
5 months, the median overall survival (OS) of patients with FGFR2b positive and HER2-negative gastric cancer or gastroesophageal junction cancer (GEJ) who received bemarituzumab and chemotherapy first-line treatment was 19.
2 Month, this value in the chemotherapy group was 13.
5 months (n=155, HR=0.
6, 95% CI: 0.
38, 0.
94)
.
Adding bemarituzumab extended the patient's median OS by 5.
7 months
.
Gastric cancer is the fourth leading cause of cancer deaths in the world.
More than 1 million new gastric cancer patients are diagnosed each year, and its incidence is particularly high in Asia
.
About 80-85% of patients with advanced gastric cancer and GEJ cancer are HER2 negative, and about 30% of them overexpress FGFR2b
.
Bemarituzumab is a monoclonal antibody against FGFR2b
.
It has a dual mechanism of action.
It can not only block the signal transduction of growth factors mediated by FGFR2b by binding to FGFR2b, but also kill cancer cells through antibody-dependent cell-mediated cytotoxicity (ADCC)
.
It received the breakthrough therapy designation granted by the FDA in April this year
.
Zai Lab has the development rights of this innovative therapy in Greater China and is responsible for the clinical trials of the drug in Greater China
.
▲The mechanism of action of bemarituzumab (picture source: Five Prime's official website) In this phase 2 clinical trial, the combination therapy of bemarituzumab has a more prominent effect on the subgroup of patients with >10% of tumor cells overexpressing FGFR2b.
This subgroup of patients The median OS was 25.
4 months, while the control group value was 11.
1 months (n=96, HR: 0.
41; 95% CI: 0.
23, 0.
74)
.
In terms of safety, the number of adverse events in the bemarituzumab+ chemotherapy group (100%) and the chemotherapy group (98.
7%) was close
.
The incidence of adverse corneal events in the Bemarituzumab+ chemotherapy group (67.
1%) was higher than that in the chemotherapy group (10.
4%).
Dry eye symptoms were the most common corneal adverse events, and most corneal adverse events were reversible
.
Dr.
David M.
Reese, Executive Vice President of Research and Development of Amgen, said: "These latest results demonstrate the clinical benefits of bemarituzumab+chemotherapy combination for patients.
We look forward to advancing bemarituzumab to the phase 3 clinical development stage
.
"Reference: [1] Phase 2 Fight Trial Continues To Show Improved Overall Survival With Bemarituzumab Plus Chemotherapy In Patients With FGFR2b+ Gastric And Gastroesophageal Cancers.
Retrieved June 4, 2021, from https:// -releases/2021/06/phase-2-fight-trial-continues-to-show-improved-overall-survival-with-bemarituzumab-plus-chemotherapy-in-patients-with-fgfr2b-gastric-and-gastroesophageal-cancers Note: This article is intended to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.