Multicenter first-in-human study of cinrebafusp alfa for previously treated HER2-positive advanced solid malignancies

CD137 is an immune receptor expressed on activated T cells, activated B cells, natural killer cells, and tumor-infiltrating lymphocytes. Cinrebafusp alfa is a bispecific antibody targeting HER2 and CD137. A multicenter first-in-human study in the United States evaluated cinrebafusp alfa for previously treated HER2-positive advanced solid malignancies. The therapy was tolerated well, with grade ≤2 infusion-related reactions being the most frequent treatment-related adverse event. The maximum tolerated dose was not reached. The overall response rate was 12.5% and the disease control rate was 52.5%. A the 8 mg/kg and 18 mg/kg dose levels, the ORRs were 28.6% and 25.0%, respectively. The authors conclude that cinrebafusp alfa demonstrated promising activity in patients with HER2-positive malignancies, who had progressed on prior HER2-targeting regimens.