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▎The content team editor of WuXi AppTec today, Amgen announced that the US FDA granted its research FGFR2b antibody therapy bemarituzumab breakthrough therapy designation, combined with chemotherapy, for the first-line treatment of HER2-negative locally advanced or metastatic gastric cancer And gastroesophageal junction (GEJ) cancer patients.
These patients showed that at least 10% of tumor cells overexpress FGFR2b using FDA-approved companion diagnostic tests.
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).
In March of this year, Amgen announced the acquisition of Five Prime Therapeutics, a company that develops bemarituzumab, for approximately US$1.
9 billion.
Zai Lab has previously reached a cooperation agreement with Five Prime to obtain the development rights of this innovative therapy in Greater China, and is responsible for clinical trials of the drug in Greater China.
▲The mechanism of action of bemarituzumab (picture source: Five Prime's official website) The award of this breakthrough therapy designation is based on the positive results of the Phase 2 clinical trial FIGHt.
In this study, the combination of bemarituzumab and chemotherapy significantly improved the progression-free survival and overall survival of patients in a subgroup of patients with at least 10% of tumor cells overexpressing FGFR2b.
Further analysis showed that clinical benefit was positively correlated with the proportion of FGFR2b-positive tumor cells.
"FIGHT clinical trial is the first study to evaluate targeted FGFR2b overexpression in cancer.
Bemarituzumab, as a first-line therapy, provides clinically significant improvements in the treatment of patients with advanced gastric cancer and GEJ cancer.
" David M.
, Executive Vice President of Research and Development, Amgen.
Dr.
Reese said, “Amgen looks forward to further research on the role of FGFR2b and will continue to cooperate with regulatory agencies to bring this potential'first-in-class' first-line therapy to patients.
” Reference: [1] Amgen's Investigational Targeted Treatment Bemarituzumab Granted Breakthrough Therapy Designation.
Retrieved April 19, 2021, from Note: This article It is intended to introduce the progress of medical and health research, not to recommend treatment options.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
These patients showed that at least 10% of tumor cells overexpress FGFR2b using FDA-approved companion diagnostic tests.
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).
In March of this year, Amgen announced the acquisition of Five Prime Therapeutics, a company that develops bemarituzumab, for approximately US$1.
9 billion.
Zai Lab has previously reached a cooperation agreement with Five Prime to obtain the development rights of this innovative therapy in Greater China, and is responsible for clinical trials of the drug in Greater China.
▲The mechanism of action of bemarituzumab (picture source: Five Prime's official website) The award of this breakthrough therapy designation is based on the positive results of the Phase 2 clinical trial FIGHt.
In this study, the combination of bemarituzumab and chemotherapy significantly improved the progression-free survival and overall survival of patients in a subgroup of patients with at least 10% of tumor cells overexpressing FGFR2b.
Further analysis showed that clinical benefit was positively correlated with the proportion of FGFR2b-positive tumor cells.
"FIGHT clinical trial is the first study to evaluate targeted FGFR2b overexpression in cancer.
Bemarituzumab, as a first-line therapy, provides clinically significant improvements in the treatment of patients with advanced gastric cancer and GEJ cancer.
" David M.
, Executive Vice President of Research and Development, Amgen.
Dr.
Reese said, “Amgen looks forward to further research on the role of FGFR2b and will continue to cooperate with regulatory agencies to bring this potential'first-in-class' first-line therapy to patients.
” Reference: [1] Amgen's Investigational Targeted Treatment Bemarituzumab Granted Breakthrough Therapy Designation.
Retrieved April 19, 2021, from Note: This article It is intended to introduce the progress of medical and health research, not to recommend treatment options.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
