Novel Chimeric Monoclonal Antibody Under Study in Metastatic Colorectal Cancer
Posted: Tuesday, August 11, 2020
Treatment with the novel monoclonal antibody ensituximab (NEO-102) exhibited “modest anticancer activity” in patients with advanced, refractory colorectal cancer who express MUC5AC, according to a study published in Clinical Cancer Research. Ensituximab targets a variant of MUC5AC. Muhammad S. Beg, MD, of the University of Texas Southwestern Medical Center, Dallas, and colleagues conducted this phase II study and presented their findings.
A total of 63 patients with advanced, refractory colorectal cancer who express MUC5AC were enrolled in the study. All patients had previously received ineffective standard treatment. Of these patients, 53 received 3 mg/kg intravenously of ensituximab every 2 weeks, as recommended by the multicenter study guidelines. Treatment was continued until disease progression or unacceptable drug-related adverse effects. The investigators reported a median overall survival of 6.8 months. After treatment with ensituximab, 21% of patients demonstrated stable disease.
Common treatment-related adverse events included fatigue (38%), anemia (30%), nausea (15%), vomiting (11%), increased bilirubin (9%), constipation (8%), decreased appetite (6%), and diarrhea (6%). Moreover, 4 of the 63 patients experienced severe adverse effects, including hypoxia, as a result of treatment with ensituximab. However, despite these adverse events, all patients completed the entire treatment regimen.
“A previously conducted phase I trial demonstrated predictable pharmacokinetic profile and elevation of IL-6 and IL-8 posttreatment,” the authors commented. “These findings provide a supporting rationale for investigating combination therapies using ensituximab with IL-15 or other agents such as chemotherapy, to enhance efficacy in this patient population.”
Disclosure: For full disclosures of the study authors, visit clincancerres.aacrjournals.org.