Ipilimumab improves survival of stage 3 melanoma patients

This study investigated the effectiveness of ipilimumab (Yervoy) in patients with stage 3 melanoma with high risk of recurrence (when cancer comes back). Researchers suggested that ipilimumab (at a dose of 10mg/kg) significantly increased survival of these patients. 

Ipilimumab is an antibody that helps the immune system to combat tumor cells. Ipilimumab was approved as an anti-tumor therapy in 2011 at a dose of 3mg/kg. However, recent studies suggested that a dose of 10mg/kg would be more beneficial for advanced melanomas.  

The objective of this study was to evaluate the benefits in survival of ipilimumab at a dose of 10mg/kg in stage 3 melanoma patients. Patients were randomly assigned, after undergoing surgery, to receive 10mg/kg (475 patients) or placebo (a substance with no effect in the body; 476 patients). Patients received the treatment every 3 weeks for four doses, then every 3 months for up to 3 years or until disease progression or toxicity. Recurrence-free survival (RFS; time from treatment to recurrence), overall survival (OS; time from treatment to death by any cause), metastasis-free survival (MFS; time from treatment to metastasis) and toxicity were measured.

The average follow-up was 5.3 years. 5-year RFS was 40.8% in the ipilimumab group compared to 30.3% in the placebo group. The 5-year OS was 65.4% in the ipilimumab group when compared to 54.4% in the placebo group. The rate of 5-year MFS in the ipilimumab group was 48.3% when compared to 38.9% in the placebo group.

465 of 471 (98.7%) patients in the ipilimumab patients experienced toxicity. Severe toxicity occurred in 54.1% of the patients in the ipilimumab group and in 26.2% in the placebo group. Severe side effects included gastrointestinal effects (16.1%), liver effects (10.8%) and hormonal (endocrine) effects (7.9%). Five patients died of side effects related to ipilimumab. 

This study suggested that treatment with 10mg/kg ipilimumab for stage 3 melanoma significantly increases survival compared to placebo, at a cost of higher toxicity.