First-line treatment of gastric cancer, Zai Lab introduces new monoclonal antibody to treat breakthrough treatment

Recently, CDE announced plans to incorporate FGFR2b monoclonal antibody FPA144 injection (bemarituzumab) into a breakthrough therapy, combined with mFOLFOX6 for the first-line treatment of FGFR2b overexpression and HER2-negative locally advanced/metastatic gastric and gastroesophageal junction cancer (G&GEJ)
.

This product is a product that Zai Lab introduced from Five Prime Therapeutics in December 2017 with a prepayment of US$5 million + a milestone of US$39 million.
In March of this year, Amgen acquired Five Prime Therapeutics for US$1.
9 billion.
The core asset is bemarituzumab
.

From: CDE official website

Currently, bemarituzumab has obtained positive data in phase II clinical trials, and phase III clinical trials are about to start
.

Bemarituzumab domestic project progress

From: Insight database

In November last year, in the Phase II clinical FIGHT study for the first-line treatment of gastric and gastroesophageal junction cancer (GEJ), bemarituzumab successfully reached the three efficacy endpoints of PFS, OS and ORR
.

The FIGHT study is a randomized, double-blind, placebo-controlled, global multicenter phase II clinical trial that compared mFOLFOX6 chemotherapy with bemarituzumab (bema, FPA144) combined with first-line treatment of the stomach or gastroesophageal junction in patients with FGFR2b+ and HER2- advanced gastric cancer.
(GEJ) Efficacy and safety of cancer
.

The results showed that the three efficacy endpoints of PFS, OS and ORR in the FIGH study all reached the statistical significance of the protocol, bilateral α=0.
20.
Compared with the placebo + chemotherapy group, the median progression-free survival (PFS) 9.
5 months vs 7.
4 months (HR=0.
68.
95%CI: 0.
44-1.
04.
p=0.
073); median overall survival (OS) did not reach vs 12.
9 months (HR 0.
58.
95%CI: 0.
35-0.
95 .
p = 0.
027); The overall response rate (ORR) increased by 13.
1% (p = 0.
106)
.

In terms of safety, there was no significant difference between the treatment group and the placebo group.
The incidence of adverse events (100% vs 98.
7%) and serious adverse events (31.
6% vs 36.
4%) were equivalent, and the incidence of ≥ grade 3 adverse reactions was treated The group was slightly higher than the placebo group (82.
9% vs 74%)
.

The fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) pathway is related to the development and growth of cancer cells
.