Pfizer Announces Phase 3 Trial Positive Results

Pfizer Announces Phase 3 Trial Positive Results

By, Admin 13 March 2024

Pfizer announces positive results from phase 3 trial of Adcetris regimen in patients with relapsed/refractory DLBCL

Pfizer Inc. announced that a phase 3 study of the antibody-drug conjugate Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to lenalidomide and rituximab plus placebo. Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).

Safety & Efficacy

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.

Pfizer on Positive Reults

“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,” 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.”

About DLBCL

  • 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 Care

  • Adcetris is 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. 
  • More than 140,000 patients have been treated with Adcetris globally. Pfizer plans to share the ECHELON-3 data with the US Food and Drug Administration (FDA) to potentially support regulatory filing in the US.

ECHELON-3 Trials

  • ECHELON-3 is an ongoing, randomized, double-blind, multicenter phase 3 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.

DLBCL: Epidemiology

  • Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of lymphoma and is an aggressive, difficult to treat disease. 
  • More than 25,000 cases of DLBCL are diagnosed each year in the United States, accounting for more than 25 per cent of all lymphoma cases.
  • DLBCL can develop spontaneously or as a result of diseases such as chronic lymphocytic lymphoma/small lymphocytic lymphoma, follicular lymphoma, or marginal zone lymphoma. 
  • Up to 40 per cent of patients relapse or have refractory disease after frontline treatment.

About ADC

Adcetris is an antibody-drug conjugate (ADC) comprised of a CD30-directed monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seagen's proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumour cells.

Adcetris Indications

  • Adcetris is approved in seven indications in the US:
  • Adult patients with previously untreated Stage III/IV classical Hodkin lymphoma (cHL) in combination with doxorubicin, vinblastine, and dacarbazine (2018);0
  • Paediatric patients 2 years and older with previously untreated high risk cHL in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide (2022); 
  • Adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation (2015); 
  • Adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates (2011); 
  • Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone (2018); 
  • Adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. (2011); 
  • Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) after prior systemic therapy (2017).

A Joint Deveolment

  • Pfizer and Takeda jointly develop Adcetris. Under the terms of the collaboration agreement, Pfizer has US and Canadian commercialization rights, and Takeda has rights to commercialize Adcetris in the rest of the world. 
  • Pfizer and Takeda are funding joint development costs for Adcetris on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

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