Galiximab, an Anti-Cd80 Primatized Monoclonal Antibody, in Relapsed Hodgkin Lymphoma: Final Results of CALGB 50602.

8039 Background: Relapsed HL patients (pts) ineligible for transplant or relapsed despite stem cell transplant have a poor prognosis and a median survival of approximately six months. Most are heavily pretreated and poorly tolerant of additional cytotoxic therapies. Targeted and non-cytotoxic therapies are needed. Galiximab is a primatized IgG1λ monoclonal antibody which binds with high affinity to CD80 (B7.1), and induces cross-linking of CD80 molecules and cell-death via ADCC. CD80 is an excellent target in HL with expression on the majority of Reed-Sternberg cells, while expression on normal tissues is limited to activated B-cells, antigen-presenting cells, and T-cells. Methods: CALGB 50602 is a phase II study of galiximab in relapsed HL after ≥ 2 prior regimens. Entry criteria included ANC ≥ 500/μ L and plts ≥ 50K/μ L. Galiximab dose was 500 mg/m2 weekly × 4 weeks followed by 500 mg/m2 q 4 weeks until progression or toxicity. The primary endpoint was response, with 4 responders in the first 21 pts req...