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Amgen Says Follow-up Phase 2 FIGHT Trial Data Shows Improved OS - Quick Facts

Amgen, Inc. (AMGN) announced on Friday updated results for investigational bemarituzumab in combination with chemotherapy from the Phase 2 FIGHT trial. The trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b-positive, HER2-negative frontline advanced gastric or gastroesophageal junction cancers (GEJ).

The new data includes median overall survival (OS), a secondary endpoint that was reached with longer follow-up, as well as additional analyses of patient subgroups.

With a median follow-up of 12.5 months, the addition of bemarituzumab to chemotherapy resulted in a median OS of 19.2 months versus 13.5 months for chemotherapy alone in all randomized patients.

In an exploratory pre-specified subgroup analysis, in patients with more than 10% of tumor cells overexpressing FGFR2b by immunohistochemistry (IHC), the median OS for bemarituzumab was 25.4 months versus 11.1 months.

The incidence of all grade adverse events was similar in the bemarituzumab plus chemotherapy and chemotherapy only arm of the study.

Gastric cancer is the fourth leading cause of cancer death globally and 30% of frontline HER2-negative gastric cancer patients have tumors that overexpress FGFR2b. More than one million new gastric cancer cases are diagnosed annually, and gastric cancer is particularly prevalent in Asia.

These updated results underscore the benefits that bemarituzumab plus chemotherapy may bring to patients who have been fighting this aggressive disease with chemotherapy alone.

In April 2021, bemarituzumab was granted Breakthrough Therapy Designation by the U.S. FDA based upon a subset of patients from the FIGHT trial who showed at least 10% of tumor cells overexpressing FGFR2b.

Amgen continues to investigate the role of FGFR2b and will continue to work with regulatory agencies on next steps, including Phase 3 development, to bring this potential first-in-class therapy to patients.

Bemarituzumab (anti-FGFR2b) is a Phase 3 ready, potential first-in-class, investigational targeted antibody that is designed to block specific fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression.

The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b-positive, HER2-negative frontline advanced gastric or GEJ cancer.

In the study, treatment with bemarituzumab plus chemotherapy demonstrated clinically significant and substantial improvements in the primary endpoint of progression-free survival (PFS) and secondary endpoint of overall survival (OS) in the patient population in which at least 10% of tumor cells overexpressed FGFR2b.

Amgen acquired bemarituzumab through the acquisition of Five Prime Therapeutics in mid-April.

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