Positive overall survival in phase III trial of Adcetris regimen in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL)

Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).

The safety and tolerability of Adcetris in the ECHELON-3 trial were consistent with what has been previously presented for patients with relapsed/refractory DLBCL treated with Adcetris in clinical trials. Full data will be submitted for presentation at an upcoming medical meeting.

This is the third Phase III study in a type of lymphoma to demonstrate an overall survival benefit for an Adcetris combination. Based on the strong results from ECHELON-3, we are excited that Adcetris could address an area of high unmet need in patients with relapsed or refractory DLBCL irrespective of CD30 expression,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. “The results are particularly encouraging because the study evaluated heavily pre-treated patients, including some who received prior CAR-T therapy.”

DLBCL is the most common type of lymphoma and is a fast-growing, aggressive blood cancer. Approximately 40% of patients with DLBCL do not respond to initial treatment or develop relapsed disease after first-line treatment.

Adcetris is a standard of care for patients with certain lymphomas and is approved for seven indications in the U.S with more than 55,000 patients treated since its first U.S. approval in 2011. More than 140,000 patients have been treated with Adcetris globally. Pfizer plans to share the ECHELON-3 data with the FD to potentially support regulatory filing in the U.S.

About ECHELON-3: ECHELON-3 is an ongoing, randomized, double-blind, multicenter Phase III study evaluating Adcetris plus lenalidomide and rituximab versus lenalidomide and rituximab plus placebo in adult patients with relapsed/refractory DLBCL, regardless of CD30 expression, who have received two or more prior lines of therapy and are ineligible for stem cell transplant or CAR-T therapy. In this global study, 230 patients were randomized across North America, Europe and Asia-Pacific. The primary endpoint is OS in the intent to treat population, with key secondary endpoints of PFS and ORR as assessed by investigator. Other secondary endpoints include complete response rate, duration of response, safety and tolerability.