Pfizer declares positive results from phase 3 trial of Adcetris regimen in relapsed/refractory DLBCL patients

Pfizer Inc. has announced positive results from a phase 3 trial of Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients. This trial demonstrated a significant improvement in overall survival (OS) compared to lenalidomide and rituximab plus placebo, with favourable outcomes in secondary endpoints like progression-free survival (PFS) and overall response rate (ORR).

Adcetris' safety profile in the ECHELON-3 trial remained consistent with previous findings. Complete data will be presented at an upcoming medical meeting.

DLBCL is aggressive, with a significant proportion of patients not responding to initial treatment or relapsing afterwards.

Adcetris, a standard treatment for certain lymphomas, has received seven US approvals since 2011, treating over 55,000 patients in the US and over 140,000 globally. Pfizer plans to share ECHELON-3 data with the US FDA for potential regulatory approval.

The ongoing phase 3 ECHELON-3 trial compares Adcetris plus lenalidomide and rituximab to lenalidomide and rituximab plus placebo in relapsed/refractory DLBCL patients. It enrolled 230 patients across multiple regions, with OS as the primary endpoint and key secondary endpoints including PFS and ORR. Adcetris, developed jointly by Pfizer and Takeda, is an antibody-drug conjugate targeting CD30-positive tumour cells.