Ian Chau, MD from Royal Marsden Hospital speaks about the ESMO 2020 abstract Initial safety and efficacy findings with bavituximab plus pembrolizumab in patients with advanced gastric or gastroesophageal cancer.
1446P Abstract
Background
In patients with advanced gastric and gastroesophageal junction (GEJ) cancer, bavituximab, an investigational, chimeric monoclonal antibody engineered to inhibit the immunosuppressive effects of phosphatidylserine, is being tested in combination with pembrolizumab. Post-hoc findings from the phase III Sunrise second-line lung cancer trial found that overall survival was substantially improved in patients who advanced on bavituximab plus docetaxel study treatment and proceeded with a checkpoint inhibitor as the next line of therapy. Cumulative data indicate that bavituximab can potentiate inhibition of the checkpoint mediated by pembrolizumab, possibly increasing overall clinical benefit.
Methodology
ONCG100 is a multicenter, open-label, single-arm, phase II global study designed to evaluate the safety, tolerability, and efficacy of bavituximab (3 mg/kg, QW) and pembrolizumab (200 mg, Q3W) in combination with advanced gastric or GEJ adenocarcinoma patients, irrespective of PD-L1 status, who have progressed to ⇠1 prior standard therapy (NCT04099641).
Outcomes
As of 23 Apr 2020, 24 out of 80 patients with a range of 1 to 4 previous therapies have been enrolled; 18 patients remain in the study. A total of 154 treatment-related emerging adverse events (TEAEs) were reported in 20 patients (83.3%) and 15 events were reported as combination-related. With the exception of anemia and dehydration, all TEAEs were reported as grade 1 or 2 (both grade 3, bavituximab-related). Tiredness (related to the combination) was the only TEAE recorded in > 2 patients. Five patients (20.8 percent) recorded sixteen severe adverse effects, all of which were recorded as unrelated to treatment, with the exception of 1 dehydration case (grade 3, bavituximab-related). There was at least one post-baseline scan assessable for anti-tumor activity in five patients: 2 partial responses, 2 stable diseases, and 1 progressive disease. Owing to an unrelated adverse condition, one patient gave up.
Findings
The 3 mg/kg dose of bavituximab with pembrolizumab with manageable adverse events and early preliminary activity was readily combined. It will present updated data from the report.