Innovative treatments for stomach cancer! Redding Pharmaceuticals / FivePrime pioneered FGFR2b targeted single-anti-bemarituzumab plus chemotherapy first-line treatment with strong efficacy!

17, 2021 // -- Zai Lab partner, Feed Prime Therapeutics, is a clinical biotech company dedicated to developing innovative therapies for cancer and inflammatory diseases.
recently, the company announced positive results for phase 2 clinical studies of advanced gastric or gastroesophageal tract connectivity (GEJ) cancer patients with the first targeted therapy bemarituzumab at the 2021 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI).
results showed that in newly diagnosed patients with fibroblast growth factor-positive (FGFR2b plus), non-HER2-positive, advanced gastric or gastroesophageal joint (GEJ) cancer, bemarituzumab significantly improved progression-free survival compared to placebo when combined chemotherapy was used for first-line treatment (median PF) S: 9.5 months vs 7.4 months; HR s 0.68), total lifetime (mid OS: not up to vs 12.9 months; HR s 0.58), total mitigation rate (ORR: 46.8% vs 33.3%).
currently, systematic (systemic) chemotherapy is the standard treatment for this deadly invasive stomach cancer.
results from theFIGHT trial showed that bemarituzumab combined chemotherapy significantly reduced disease progress and risk of death in patients with stomach cancer who over-expressed FGFR2b.
fibroblast growth factor (FGF)/fibroblast growth factor (FGFR) path is involved in the growth and development of tumor cells.
FGFR2b is a cut form of FGFR that can be found in endothing tumors.
data from theFIGHT trial show that about 30% of non-HER2-positive gastroesophageal cancer patients overexploited FGFR2b.
Five Prime and Roche Diagnostics also found that FGFR2b was overexpressed in many other cancers, including squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), ovarian cancer, pancreatic cancer, and intra-liver bile tube cancer.
bemarituzumab (anti-FGFR2b monoanti) was developed byIve Prime, and Zai Lab is exclusively licensed in Greater China.
the drug is a pioneering (first-in-class) targeted antibody that prevents FGF from binding and activating FGFR2b, inhibits a variety of downstream tumor-promoting signaling pathfours, and may delay cancer progression.
, bemarituzumab is currently being developed in stomach and GEJ cancers as a targeted treatment for FGFR2b overexposed tumors.
the company is also evaluating the potential of bemarituzumab in other FGFR2b overexposed tumors.
The Company granted exclusive license to the development and commercialization of Bemarituzumab in Greater China, and Reed Pharmaceuticals conducted phase 2 FIGHT trials in Greater China in collaboration withIve Prime.
bemarituzumab mechanism of action.pngFIGHT is a global, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of bemarituzumab and placebo in newly diagnosed patients with fibroblast growth factor complex 2b-positive (FGFR2b plus), non-HER2-positive, advanced gastric or gastroesophageal connectivity (GEJ) cancer.
the trial involved 155 patients in 15 countries in Asia, the European Union and the United States, 77 of whom were randomly assigned to the bemarituzumab treatment group (bemarituzumab plus mFOLFOX6) and 78 were assigned to the placebo group (placebo plus mFOLFOX6).
results showed that the study reached all three therapeutic endpoints: compared to the placebo group, patients in the bemarituzumab group showed statistically significant and clinically significant improvements in the primary endpoints of progress-free survival (PFS), total survival (OS) and secondary endpoints of total remission (ORR).
additional analysis showed that the therapeutic benefits were positively corred with the percentage of FGFR2b plus tumor cells, confirming the importance of the FGFR2b target and the activity of bemarituzumab on the target.
specific data are: (1) in terms of the main endpoint PFS, the bemarituzumab group was significantly longer than the placebo (medium PFS: 9.5 months vs. 7.4 months), and the risk of disease progression or death was reduced by 32% (HR=0.68; 95% CI:0.44-1.04; p=0.073).
(2) secondary endpoint OS, the bemarituzumab group was significantly longer than the placebo (mid-OS: not up to the level of the snr vs. 12.9 months), and the risk of death was reduced by 42% (HR-0.58; 95% CI:0.35-0.96; p-0.027).
(3) secondary endpoint ORR, the bemarituzumab group increased significantly compared to the placebo group (ORR: 46.8% vs 33.3%).
safety, the rates of adverse events at all levels were similar in the bemarituzumab group and the placebo group (100% and 98.7%, respectively).
corneal events were more common in the bemarituzumab group (67.1% vs 10.4%), with the most common corneal events in the bemarituzumab group being dry eye disease (26.3%), cornealitis (15.8%) and point cornealitis (14.5%).
(31.6% vs 13.0%) and elevated transaminase (34.2% vs 19.5%) were also more common in the bemarituzumab group.
level 3 and above adverse events (82.9% vs. 74.0%), serious adverse events (31.6% vs 36.4%) and death (6.6% vs 5.2%) were comparable among the groups.
eye events are common in FGFR targeted therapy and have been reported in THEFIGHT trials.
the trial, more patients in the bemarituzumab group stopped treatment for adverse events (34.2% vs. 5.2%) than in the placebo group, and the majority of those patients (21 out of 26 patients) discontinued bemarituzumab due to eye events.
deactivation of bemarituzumab due to eye events reduced the median duration of bemarituzumab exposure by 3.2 weeks Reduced from 25.3 weeks (n-55, range: 2.0-71.7 weeks) to 22.1 weeks (n-21, range: 12.0-46.7 weeks).
designing the Phase 3 trial, Five Prime plans to incorporate the findings of the FIRE trial, including baseline eye examination, preventive lubrication of eye drops, and close monitoring of signs and symptoms of corneal toxicity, including dry eye disease. Dr Helen Collins, Executive Vice President and Chief Medical Officer,
Five Prime, said, "The results of this Phase 2 clinical trial validate our ground-breaking work on the role of FGFR2b overexploitation in stomach cancer, and we are excited about the potential of this new scientific understanding for the application of other cancers.
with this data, we plan to continue to work with regulators to launch a global Phase 3 trial of stomach cancer and begin studying the role of bemarituzumab in other overexposed FGFR2b endothroid cancers.
Origin: Phase 2 FIGHT Trial Results Presented at ASCO GI Validate Importance of FGFR2b Overexpression and Reinforce Potential of Bemarituzumab Plus Processing as Frontline Targeted for Treatment FGFR2b<!--/ewebeditor:page->