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Bemarituzumab Safe, Active for Advanced Gastroesophageal Cancer
Bemarituzumab was well-tolerated as late-line therapy in patients with advanced FGFR2b-overexpressing gastric and gastroesophageal junction adenocarcinoma (GEA), findings from a phase 1 dose-escalation and expansion study show (J Clin Oncol. 2020 Mar 13. Epub ahead of print).
According to Daniel V. T. Catenacci, MD, PhD, University of Chicago, Illinois, and colleagues, the trial was necessary for assessment of the safety, pharmacokinetics, and preliminary activity of bemarituzumab in patients with FGFR2b-overexpressing GEA.
The phase 1 trial comprised 3 sections; part 1a consisted of dose-escalation for patients with recurring solid tumors; part 1b focused on dose escalation of patients with advanced GEA; and part 2 consisted of dose-expansion in 4 cohorts of patients with advanced-stage GEA that overexpressed FGFR2b at various levels (ie, high, medium, low, and no FGFR2b overexpression) as well as 1 cohort of patients with FGFR2b-overexpressing advanced-stage bladder cancer.
A total of 79 patients were enrolled in the study, and the recommended dose of bemarituzumab was identified after part 1 as 15 mg/kg every 2 weeks.
Fatigue (17.7%), nausea (11.4%), and dry eye (10.1%) were the most common treatment-related adverse events. In addition, while 3 patients reported reversible grade 2 corneal events, no grade 4 adverse events were documented.
Of 28 patients with high FGFR2b-overexpressing GEA, 5 (17.9%; 95% CI, 6.1%-36.9%) had a confirmed partial response.
“Overall, bemarituzumab seems to be well tolerated and demonstrated single-agent activity as late-line therapy in patients with advanced-stage GEA,” Dr Catenacci et al concluded.
“Bemarituzumab is currently being evaluated in combination with chemotherapy in a phase III trial as front-line therapy for patients with high FGFR2b-overexpressing advanced-stage GEA,” they added.—Kaitlyn Manasterski
