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On April 19, 2021, Amgen announced that the 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 gastroesophagus Patients with cancer of the junction (GEJ)
.
The FDA-approved companion diagnostic test in these patients showed that at least 10% of tumor cells overexpress FGFR2b
Bemarituzumab is a monoclonal antibody against FGFR2b, independently developed by Five Prime
.
On November 10, 2020, Five Prime announced the results of a phase 2 clinical trial for gastric cancer: Compared with chemotherapy, the use of Bemarituzumab combined with chemotherapy improved the median progression-free survival (PFS) of patients with advanced gastric cancer from 7.
4 months By 9.
5 months, more importantly, the overall survival (OS) of patients has also been significantly improved (12.
9 months vs.
not yet reached, HR 0.
58, 95% CI: 0.
35-0.
95, p=0.
027)
.
In this global clinical trial, patients included gastric cancer and gastroesophageal junction (GEJ) cancer
Stimulated by this news, Five Prime's stock price rose 364% after the market closed
.
It is reported that as early as December 2017, Five Prime granted Zai Lab an exclusive license to develop and commercialize bemarituzumab in Greater China
.
In March of this year, Amgen spent US$1.
As a monoclonal antibody against FGFR2b, bemarituzumab 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 through antibody-dependent cell-mediated cytotoxicity (ADCC).
) Kill cancer cells
.
FGFR2b is a subtype of FGFR found in epithelial cells in the stomach and skin
.
About 30% of HER2-negative gastroesophageal cancer patients overexpress FGFR2b
The award of this breakthrough therapy designation is based on the positive results of the Phase 2 clinical trial FIGHt
.
The FIGHT study enrolled 155 newly diagnosed FGFR2b-positive, locally advanced or metastatic gastric cancer and gastroesophageal junction cancer patients in 15 countries including Asia, the European Union, and the United States.
The results showed that the median PFS in the Bemarituzumab group was 2.
1 months longer than that in the placebo group (9.
5 vs 7.
4 months, HR=0.
68, 95% CI: 0.
44-1.
04, p=0.
0727), the median OS had not yet reached, and the placebo group was 12.
9 months (HR=0.
58, 95% CI: 0.
35-0.
95, p=0.
0268); ORR increased by 13% (p=0.
106)
.
Gastric cancer is currently one of the most common malignant tumors in the world.
Its incidence and fatality rate ranks second in China, and its incidence ranks fifth and second in mortality worldwide
.
For the treatment of gastric cancer, surgery is still combined with systemic chemotherapy at this stage.
In recent years, with researchers' in-depth research on immunotherapy, some targeted drugs and chemical drugs have gradually gained recognition
.
However, due to the high heterogeneity of gastric cancer and few available targets, the clinical application of these drugs has been greatly restricted.
In addition, with the in-depth development of clinical research, scientists have also found that the higher the degree of FGFR gene amplification, the better the response to FGFR inhibitors
.
This also suggests that FGFR can not only be used as a target, but is also expected to be a predictor of efficacy
We hope that the research on FGFR will achieve more new breakthroughs and develop more effective and innovative therapies, so as to benefit more patients
.
reference:
1.
Amgen's Investigational Targeted Treatment Bemarituzumab Granted Breakthrough Therapy Designation.
Retrieved April 19, 2021, from https:// -301271859.
html;
2.
FGFR2-related pathogenesis and FGFR2-targeted therapeutics (Review);
3.
Wainberg Z, Enzinger P, Kang YK, et al.
A double-blind randomized study of bemarituzumab (bema) plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line treatment for advanced gastric/gastroesophageal junction cancer (FIGHT).
2021 ASCO- GI.
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