Siltuximab: Phase II data

The double-blind, international, pivotal Phase II MCD2001 trial in 79 patients with MCD who are HIV-negative and human herpes virus 8 (HHV-8)-negative showed that 11 mg/kg IV siltuximab every 3 weeks plus best supportive care (BSC) led to a greater durable tumor and symptomatic response rate, the primary endpoint, vs. placebo plus BSC (34% vs. 0%, p=0.0012). The primary analysis occurred after the last treated patient completed assessments at week 48. Median time to treatment failure was not reached in the siltuximab arm vs. 134 days in the placebo arm. Additionally, a significantly greater proportion of patients in the siltuximab arm achieved durable complete MCD-related symptom resolution, defined as a 100% reduction of baseline overall symptom scores for >=18 weeks, vs. the placebo arm (25% vs. 0%, p=0.0037). Median treatment duration was 375 days with siltuximab vs. 152 days with placebo. The most common grade 3 or higher adverse events reported were fatigue, night sweats, hyperkalemia, hyperuricemia, localized edema, hyperhidrosis, neutropenia, thrombocytopenia, hypertension and weight increase. Data were presented at the American Society of Hematology meeting in New Orleans. ...