Additional Relevant Details
The AETHERA trial demonstrated that patients with Hodgkin lymphoma who received ADCETRIS (plus best supportive care) as consolidation therapy immediately following ASCT lived significantly longer without disease progression compared to patients who received placebo (plus best supportive care) as assessed by an independent review committee (hazard ratio=0.57; p-value=0.001), which equates to a 75 percent improvement in PFS. PFS was assessed after a minimum of two years post initiation of treatment for all study patients. An updated analysis conducted after three years of follow up showed sustained PFS improvement (per independent review committee; HR=0.58; 95%CI (0.41,0.81). A pre-specified interim analysis of overall survival showed no statistically significant difference between the treatment arms. The most common adverse reactions (≥1/10) seen across all trials were infection, upper respiratory tract infection, neutropenia, peripheral neuropathy (sensory and motor), cough, dyspnea, diarrhea, nausea, vomiting, constipation, abdominal pain, alopecia, pruritus, myalgia, arthralgia, fatigue, chills, pyrexia, infusion-related reactions and weight decrease. The safety profile of ADCETRIS in the AETHERA trial was generally consistent with the existing prescribing information.