Pfizer's Adcetris Phase 3 Trial Success in DLBCL Patients

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Pfizer Inc. recently announced positive results from a phase 3 clinical study of the antibody-drug conjugate Adcetris (brentuximab vedotin), used in combination with lenalidomide and rituximab for treating patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). 

The study showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to lenalidomide and rituximab plus placebo. The secondary endpoints, such as progression-free survival (PFS) and overall response rate (ORR), also showed positive outcomes.

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

According to Dr. Roger Dansey, Chief Development Officer, Oncology, Pfizer, "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."

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

Adcetris is already a standard of care for patients with certain lymphomas and is approved for seven indications in the US, with more than 55,000 patients treated since its first US approval in 2011. Over 140,000 patients have been treated globally with Adcetris. Pfizer plans to submit the ECHELON-3 data to the US Food and Drug Administration (FDA) to support regulatory filing in the US.

ECHELON-3 is an ongoing, randomized, double-masked, multicenter phase 3 study that evaluated Adcetris plus lenalidomide and rituximab versus lenalidomide and rituximab plus placebo in adult patients with relapsed or 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.

The study was conducted globally, with 230 patients 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 the investigator. Other secondary endpoints include complete response rate, duration of response, safety, and tolerability.