Pfizer Reports Promising Results in Phase 3 Trial of Adcetris Regimen for Relapsed/​Refractory Diffuse Large B-cell Lymphoma

Pfizer announced March 12 positive survival results from a phase 3 trial of Adcetris (brentuximab vedotin) as part of a combination regimen with Rituxan (rituximab) and Revlimid (lenalidomide) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Pfizer also reported positive outcomes in progression-free survival and overall response rate. The safety and tolerability of Adcetris were consistent with previous clinical trial data.

DLBCL is the most common type of lymphoma and is a fast-growing, aggressive blood cancer. After initial treatment, around 40% of patients with DLBCL do not respond to treatment (described as having refractory disease) or experience relapsed disease.

Adcetris was first approved by the FDA in 2011. It is currently indicated to treat several types of lymphoma including Hodgkin lymphoma in adults and children ages 2 and older. Adcetris belongs to a class of medications called antibody-drug conjugates (ADCs). The drug is comprised of two connected parts: a monoclonal antibody that targets a protein called CD30 and a chemotherapy drug designed to enter and kill cancer cells. CD30 commonly found on the surface of certain blood cancers but less so on healthy cells.

The trial, known as ECHELON-3, evaluated Adcetris in combination with Revlimid and Rituxan compared to Revlimid and Rituxan plus placebo in adult patients with relapsed/refractory DLBCL who have received two or more prior lines of therapy and are ineligible for stem cell transplant or CAR-T therapy.

This announcement is especially encouraging as the study included patients that have already tried multiple types of treatments, some of whom had received prior CAR-T therapy.

Pfizer plans to share the full data from the ECHELON-3 trial with the FDA to potentially support a new indication.

Adcetris was originally developed by Seagen, a biotechnology company that specialized in ADC technology, in collaboration with Takeda. Pfizer acquired Seagen last year for approximately $43 billion.