After a median follow up of 22.9 months, the primary end point (objective global response of at least 4 months) was achieved in 56.3% of the BV arm versus 12.5% in the best supportive arm which is an improvement of 43.8% (95% CI 29.1–58.4; p<0.0001).
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Median progression-free survival (EMA criteria) was 16.7 months versus 3.5 months (HR 0.270, 95% CI 0.169–0.430; p<0.0001; adjusted p<0.0001). Median duration of response for the 43 responders to BV was 15.1 months (95% CI 9.7–25.5) versus 18.3 months (3.5–18.4) for the 13 responders to physician’s choice treatment.
Patient reported symptoms (Skindex-29), showed significantly greater symptom reduction in the brentuximab vedotin group, compared with the physician’s choice group, with a mean maximum reduction of –27.96 (SD 26.877) versus –8.62 (17.013; p<0.0001).
A final analysis has been presented in abstract form at ICML15.r At a median follow-up of 45.9 months, the benefit in median progression free survival was maintained (16.7 v 3.5 months, p<0.001). Similar numbers of patients had received subsequent therapy in each group (78% v 75%), but median time to next therapy remained significantly longer in the BV treated group (14.2 v 5.6 months, p<0.001).