Brentuximab Vedotin Combo Shows Improvement in DLBCL Survival

Pfizer recently announced the positive Phase 3 results of the ECHELON-3 trial, which evaluates brentuximab vedotin (ADCETRIS) in combination with lenalidomide and rituximab for treating relapsed or refractory diffuse large B-cell lymphoma. These results showed vast improvement in all efficacy outcomes compared to the lenalidomide and rituximab dual combination.

What Is DLBCL?

Diffuse large B-cell lymphoma (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.”

One of the first signs of DLBCL is a quickly growing mass that is usually an enlarged lymph node in the neck, groin, or stomach. Patients may also experience fever, weight loss, and drenching night sweats. Fatigue or cough may also be persistent. DLBCL is the fastest-growing form of non-Hodgkin lymphoma (which occurs when white blood cells, known as lymphocytes, grow out of control).

The current standard of care has been chemotherapy, single-agent rituximab/obinutuzumab, single-agent lenalidomide, or combinations of these agents. However, this new immunotherapy combination has shown promising results in patients with progressive disease or whose disease was no longer responding to therapy (refractory). This study focused on heavily pre-treated patients as well as some who had received CAR-T therapy.

Learn all the basics of DLBCL with the HealthTree 101 article series.

What Is ECHELON-3?

ECHELON-3 is an ongoing clinical trial in Phase 3, which recruited 230 patients from multiple centers in North America, Europe, and Asia-Pacific. The trial evaluates the effectiveness of ADCETRIS, lenalidomide, and rituximab for treating adult patients who have relapsed/refractory DLBCL. The trial is double-blind and randomized, and it includes patients who have received two or more prior lines of therapy. Patients who are ineligible for stem cell transplant or CAR-T therapy can also participate in the trial, regardless of CD30 expression. The objective of the study is to determine the safety and efficacy of the treatment.

What Is ADCETRIS?

Brentuximab vedotin (ADCETRIS) is an antibody-drug conjugate (ADC) that binds to a protein called CD30, which is found on some lymphoma cells. The antibody part (brentuximab) recognizes the lymphoma cell, and it is attached to a potent anticancer drug (vedotin), which helps kill cancer cells in a more targeted way. 

ADCETRIS is a medication that has been approved for use in the United States for seven indications. These indications include the treatment of classical Hodgkin lymphoma, systemic anaplastic large-cell lymphoma, primary cutaneous anaplastic large-cell lymphoma, and other types of peripheral T-cell lymphomas. ADCETRIS has also been approved for use in patients who have previously undergone chemotherapy and/or stem cell transplantation.

Side Effects Of Brentuximab vedotin

Brentuximab vedotin can cause side effects, but some people experience none or mild ones. The most common side effects reported in lymphoma patient were:

• Peripheral neuropathy: This means tingling, numbness, or pain in the hands and feet.
• Fatigue: Feeling tired or lacking energy.
• Low blood cell counts: This can increase your risk of infection or make you bruise more easily. Doctors will monitor your blood counts regularly.
• Pulmonary events: Some people experience lung problems, including cough, shortness of breath, or trouble breathing. 
• Infection: Brentuximab vedotin can weaken your immune system, making you more prone to infections. Patients experienced signs of infection such as fever, chills, and body aches.
• Infusion reactions: These can happen during the medication administration and may include fever, chills, headache, nausea, or trouble breathing. 
• Tumor lysis syndrome (TLS): This can occur when treatment causes cancer cells to break down too quickly. Symptoms can include muscle weakness, fatigue, nausea, and difficulty urinating. 

The manufacturer has not yet shared the details on the survival benefit of the brentuximab vedotin combination but will use them to request evaluation for approval by the FDA.

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Source: 

• Pfizer Announces Positive Overall Survival in Phase 3 Trial of ADCETRIS® Regimen in Patients with Relapsed/​Refractory Diffuse Large B-cell Lymphoma