Efficacy

SYLVANT® (siltuximab) Proven clinical efficacy in Multicentric Castleman’s Disease Treatment

In the pivotal study (N=79), SYLVANT® plus best supportive care (BSC)* provided significant improvements in durable tumor and symptom response1

34% of patients on SYLVANT® + BSC* achieved durable tumor and symptom response vs 0% for placebo + BSC, based on an independent review (P=0.0012).

* BSC included management of effusions; administration of antipyretics, antipruritics, antihistamines, and pain medication; management of infections and infusion-related reactions; and other supportive treatments.2

Durable tumor and symptomatic response was defined as tumor response (PR and CR based on modified International Working Group response criteria for malignant lymphoma) assessed by independent review and complete resolution or stabilization of Multicentric Castleman's Disease symptoms, both for ≥18 weeks without treatment failure.1

Durable tumor and symptom response by independent review1.2

SYLVANT® Durable Tumor and Symptom Response

 

STUDY DESIGN

  • A phase 2, multinational, randomized (2:1), double-blind, placebo-controlled study was conducted to assess the efficacy and safety of SYLVANT® + BSC compared with placebo + BSC in patients with Multicentric Castleman's Disease (MCD)1 who are HIV negative and HHV-8 negative. Treatment was continued until treatment failure or unacceptable toxicity
  • A total of 79 patients with symptomatic Multicentric Castleman's Disease (MCD) were randomized and treated. Median age was 48 years (range 20-78), and 66% of patients were male. The primary end point was durable tumor and symptomatic response
  • 53 patients were randomized to receive SYLVANT® 11 mg/kg every 3 weeks plus BSC

Treatment failure was defined as disease progression based on increase in symptoms, radiologic progression, or deterioration in performance status.1

References

  1. SYLVANT® [package insert]. Horsham, PA: Janssen Biotech, Inc.
  2. Data on file. Janssen Biotech, Inc.