The results of the late-stage trial showed a statistically significant and clinically meaningful changes in overall survival and key secondary endpoints of progression free survival and overall response rate
Pfizer gained access to Adcetris via the $43bn acquisition of Seagen. (Credit: Pfizer Inc.)
Pfizer said that the Adcetris (brentuximab vedotin) combination with lenalidomide and rituximab has delivered significant improvement in overall survival (OS) in the Phase 3 ECHELON-3 trial in patients with certain types of lymphoma, thus meeting the primary endpoint.
Adcetris is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody directed against CD30.
Pfizer gained access to the blood cancer therapy via the $43bn acquisition of Seagen, which was completed in December last year.
ECHELON-3 assessed the Adcetris combination therapy in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
It included patients who were administered with two or more prior lines of therapy and were not eligible for stem cell transplants.
The ongoing, randomised, double-blind, multicentre study evaluated the combination in 230 patients against lenalidomide and rituximab plus placebo.
The trial also showed significant improvement in key secondary endpoints of progression free survival (PFS) and overall response rate (ORR) with the combination treatment compared to lenalidomide and rituximab plus placebo.
Additionally, the late-stage study confirmed that Adcetris’ safety and tolerability were in line with the results of other clinical trial studies including patients with relapsed or resistant DLBCL.
Pfizer oncology chief development officer Roger Dansey said: “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 strong results from ECHELON-3, we’re excited that Adcetris could address an area of high unmet need in patients with relapsed or refractory DLBCL irrespective of CD30 expression.
“The results are particularly encouraging because the study evaluated heavily pre-treated patients, including some who received prior CAR-T therapy.”
The cancer drug is already approved for seven indications in the US. The approval for R/R DLBCL will pave the way for the eighth approval.
The American drug maker plans to share the ECHELON-3 results with the US Food and Drug Administration (FDA) to potentially back regulatory filing in the US.