Abstract / Summary
Advanced gastric and gastroesophageal junction (gastric/GOJ) adenocarcinomas have poor outcomes, and the benefit of immune checkpoint inhibitors (CPIs) remains limited. Bavituximab is a phosphatidylserine-targeting monoclonal antibody that modulates the immune and vascular tumour microenvironment. This Phase 2, open-label, multinational study evaluated bavituximab plus pembrolizumab in previously treated advanced gastric/GOJ. Patients were stratified into CPI-naïve (n = 61) and CPI-relapse (n = 19) cohorts. Bavituximab (3 mg/kg weekly) was combined with pembrolizumab (200 mg every 3 weeks) until disease progression or unacceptable toxicity. Primary endpoints included the safety and objective response rate (ORR) per RECIST 1.1. Secondary endpoints included the disease control rate (DCR), progression-free survival, overall survival, and exploratory biomarker analyses using the Xerna TME Panel and the neutrophil-to-lymphocyte ratio (NLR). No dose-limiting toxicities were observed. The most common treatment-emergent adverse events were fatigue (32.5%), constipation (31.3%), and decreased appetite (31.3%). The ORR was 13.1% in CPI-naïve and 5.3% in CPI-relapse patients; the median duration of response was 12.5 months in the CPI-naïve cohort. The DCR was 39.3% and 52.6% respectively. Higher ORRs were observed in patients with immune-high (B+) subtypes (21.9%), NLR < 4 (17.9%) and B+/NLR < 4 (33%). Bavituximab plus pembrolizumab was well tolerated but showed modest activity, with greater benefit in biomarker-defined subgroups, supporting the biomarker-driven development of tumour microenvironment-targeting combinations in advanced gastric/GOJ adenocarcinomas. NCT04099641.
Primary Source
Current oncology (Toronto, Ont.)
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