Addition of bermarituzumab to mFOLFOX treatment outperforms placebo
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For patients with 1L FGFR2b+ advanced gastric/gastroesophageal junction adenocarcinoma, adding bemarituzumab to modified FOLFOX6 treatment improved overall survival vs. mFOLFOX 6 alone, according to data from a phase 2 study presented at ASCO21.
"Progression-free survival, the primary endpoint, and overall survival secondary endpoint, favored bemarituzumab over placebo in the intention to treat analysis as well as pre-specified subgroups," Daniel V.T. Catenacci, MD, an adult gastrointestinal medical oncologist and director of the Gastrointestinal Oncology Program at the University of Chicago, said.
Researchers randomly assigned 155 eligible patients into two groups; one treated with FOLFOX and bemarituzumab and one treated with FOLFOX and placebo. The bemarituzumab dosage was set at 15 mg/kg every 2 weeks, with a single dose at 7.5 mg/kg on day 8 of the first cycle.
"At a longer median follow-up time of 12.5 months, modified FOLFOX6 plus bemarituzumab increased overall survival by an absolute of 5.7 months vs. placebo in patients with overexpressing FGFR2b tumors," Catenacci said.
"This benefit was more pronounced at the 5% extensity cutoff and most pronounced in the 10% extensity cutoff," he said.
Study data showed that patients with FGFR2b overexpression without ctDNA gene amplification benefited most from treatment with bemarituzumab.
"Bemarituzumab improved clinical outcomes in patients with tumor FGFR2b positive overexpression irrespective of ctDNA FGFR2 gene amplification status, while ctDNA positive tumors seemed to drive the most benefit," Catenacci said.
Corneal adverse events were noted with a delayed onset, which "may allow an opportune time to intervene with prophylactic measures," Catenacci said.
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