The addition of IWILFIN maintenance therapy following standard of care upfront treatment¹

The efficacy of IWILFIN is based on an externally controlled trial comparison of outcomes between Study 3b (investigational arm) and Study ANBL0032 (clinical trial–derived external control arm). 

• Study 3b (IWILFIN-treated patients): A multicenter, open-label, non-randomized trial. Pediatric patients with high-risk neuroblastoma who demonstrated at least a partial response to the standard of care upfront therapy, consistent with ANBL0032 treatment protocol, received IWILFIN orally twice daily for a maximum of 2 years 
• Study ANBL0032 (external control): A multicenter, open-label, randomized trial of dinutuximab, granulocyte-macrophage colony-stimulating factor, interleukin-2, and cis-retinoic acid compared to cis-retinoic acid alone in pediatric patients with high-risk neuroblastoma 

IWILFIN improved outcomes in primary matched comparison^1,2  

52% reduction in the risk of relapse with IWILFIN 

Primary Endpoint: Event free survival (EFS)

EFS is defined as the period from the last day of immunotherapy until the first occurrence of relapse, progressive disease, secondary cancer, or death.

68% reduction in the risk of death with IWILFIN 

Secondary Endpoint: Overall survival (OS)

OS is defined as the first day of administration of IWILFIN until death due to any cause.

IWILFIN offers an established safety profile with manageable side effects¹ 

Of 360 patients with high-risk neuroblastoma who received IWILFIN as maintenance therapy in clinical studies, IWILFIN was generally well tolerated 

Adverse reaction rates (≥5%) in patients who received IWILFIN in a pooled safety population (n=360) 

Most common (≥2%) grade 3 or 4 laboratory abnormalities (n=360) 

ALT, alanine aminotransferase; AST, aspartate aminotransferase.