Regulatory Decision Summary for Adcetris

The efficacy of Adcetris as maintenance therapy over best standard of care (i.e. "watchful waiting" with the option to receive Adcetris after disease progression) in patients with classical Hodgkin lymphoma (HL) who are at high risk of disease progression following autologous hematopoietic stem cell transplantation (ASCT) was demonstrated in the AETHERA study by an improvement in progression-free survival of 18.8 months (HR 0.57 [95% CI: 0.40, 0.81]). At the time of analysis (median PFS follow-up time of 22.1 months), 36% of patients in the Adcetris arm versus 46% in the placebo arm had disease progression or died.

The benefit of Adcetris as maintenance therapy is assessed in context with the toxicity associated with the drug. More patients in the Adcetris arm than in the placebo arm experienced any adverse events (AEs), high grade AEs, serious AEs, and AEs leading to dose modification or treatment discontinuation. Peripheral neuropathy (PN) of any grade was experienced by 67% of Adcetris -treated patients compared to 19% of placebo patients. Severe cases of PN were mostly reported in Adcetris -treated patients. For patients who are determined to be at an increased risk of relapse following ASCT, the benefit/risk balance of Adcetris maintenance therapy is considered to be favourable. Most treatment related toxicity can be managed with dose adjustments or discontinuation of treatment, and mitigated with close monitoring as per recommendations included in the updated Adcetris Product Monograph.