Pfizer Reports Encouraging Overall Survival Results in Phase 3 Study of ADCETRIS® Treatment for Relapsed/Refractory Diffuse Large B-cell Lymphoma

Pfizer Inc. (NYSE: PFE) has disclosed promising findings from a Phase 3 clinical trial investigating the efficacy of the antibody-drug conjugate ADCETRIS® (brentuximab vedotin) in conjunction with lenalidomide and rituximab for treating patients afflicted with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This study demonstrated a statistically significant and clinically meaningful enhancement in overall survival (OS) compared to the combination of lenalidomide and rituximab with placebo. Additionally, positive outcomes were observed in crucial secondary endpoints, such as progression-free survival (PFS) and overall response rate (ORR).

The safety profile of ADCETRIS in the ECHELON-3 trial remained consistent with previous presentations in clinical trials involving patients with relapsed/refractory DLBCL who received ADCETRIS treatment. Comprehensive data will be submitted for presentation at an upcoming medical conference.

Dr. Roger Dansey, Chief Development Officer of Oncology at Pfizer, expressed enthusiasm regarding these results, highlighting that this marks the third Phase 3 trial in lymphoma types to demonstrate an overall survival benefit with an ADCETRIS combination. He emphasized the potential of ADCETRIS to address an area of significant unmet need in patients grappling with relapsed or refractory DLBCL, irrespective of CD30 expression. Notably, the study included heavily pre-treated patients, including some who had undergone prior CAR-T therapy.

DLBCL stands as the most prevalent type of lymphoma, characterized by its rapid growth and aggressiveness. Approximately 40% of DLBCL patients fail to respond to initial treatment or experience disease relapse following first-line therapy.

ADCETRIS has established itself as a standard of care for certain lymphomas and has garnered approval for seven indications in the United States, with over 55,000 patients receiving treatment since its initial U.S. approval in 2011. Globally, more than 140,000 patients have been treated with ADCETRIS. Pfizer intends to present the ECHELON-3 data to the U.S. Food and Drug Administration (FDA) to potentially support a regulatory filing in the U.S.

ECHELON-3 is an ongoing Phase 3 trial, conducted across multiple centers and regions, which compares the efficacy of ADCETRIS plus lenalidomide and rituximab versus lenalidomide and rituximab plus placebo in adult patients suffering from relapsed/refractory DLBCL, regardless of CD30 expression. Participants had undergone two or more prior lines of therapy and were ineligible for stem cell transplant or CAR-T therapy.

The primary endpoint of the study is overall survival (OS) in the intent-to-treat population, with key secondary endpoints including progression-free survival (PFS) and overall response rate (ORR), as assessed by investigators. Other secondary endpoints consist of the complete response rate, duration of response, and safety and tolerability assessments.

DLBCL represents the most frequent form of lymphoma and is notoriously challenging to treat. More than 25,000 cases of DLBCL are diagnosed annually in the United States, constituting over 25 percent of all lymphoma cases. DLBCL can manifest spontaneously or develop as a consequence of other diseases such as chronic lymphocytic lymphoma/small lymphocytic lymphoma, follicular lymphoma, or marginal zone lymphoma. Up to 40 percent of patients experience relapse or refractory disease post-first-line treatment.

ADCETRIS is an antibody-drug conjugate (ADC) comprising a CD30-directed monoclonal antibody linked via a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seagen’s proprietary technology. The ADC employs a linker system designed to remain stable in the bloodstream but release MMAE upon internalization into CD30-positive tumor cells.

ADCETRIS has secured approval for seven indications in the U.S., spanning various lymphoma types and treatment scenarios.

Pfizer collaborates with Takeda in the development of ADCETRIS, with Pfizer holding commercialization rights in the U.S. and Canada, while Takeda holds rights for the rest of the world. Development costs for ADCETRIS are shared equally between Pfizer and Takeda, except in Japan, where Takeda bears sole responsibility for development costs.

ADCETRIS® (brentuximab vedotin) for injection U.S. Important Safety Information:

[Important safety information provided as per the original article]

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the potential benefits of ADCETRIS. The forward-looking statements in this press release are based on information available to Pfizer as of the date of the release, and Pfizer assumes no obligation to update any forward-looking statements contained in this press release as a result of new information or future events or developments.

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