Pfizer announces positive overall survival in the phase 3 trial of the ADCETRIS regimen in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
The ECHELON-3 trial of ADCETRIS in combination with lenalidomide and rituximab showed a significant improvement in the primary endpoint of overall survival and the secondary endpoints of progression-free survival and overall response rate compared with lenalidomide and rituximab plus placebo, independent of CD30 expression.
Pfizer will discuss a regulatory submission with the FDA, which could lead to an eighth indication for ADCETRIS.
' This is the third phase 3 study in a type of lymphoma to demonstrate an overall survival benefit for an ADCETRIS combination. Based on the excellent results of ECHELON-3, we are delighted that ADCETRIS can address an area of high unmet need in patients with relapsed or refractory LDGCB, regardless of CD30 expression', said Roger Dansey, M.D., Director of Development, Oncology, Pfizer.
' The results are particularly encouraging because the study evaluated heavily pretreated patients, including some who had previously received CAR-T therapy. '
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