How may I benefit from ADCETRIS?
ECHELON-3 study design
ECHELON-3 was a large, international, clinical study of 230 people that compared the effectiveness and safety of ADCETRIS plus lenalidomide and rituximab to placebo plus lenalidomide and rituximab in adult patients with relapsed or refractory DLBCL after 2 or more prior treatments.
- 112 people were assigned to receive ADCETRIS plus rituximab every 3 weeks and take lenalidomide (oral medication) daily until disease progression or if side effects were unacceptable
- 118 people were assigned to receive placebo plus rituximab every 3 weeks and take lenalidomide (oral medication) daily until disease progression or if side effects were unacceptable
Researchers reviewed the overall survival results (primary endpoint) and the overall response rate (secondary endpoint) at approximately 16 months.
Overall survival results
Overall survival was significantly higher with ADCETRIS plus lenalidomide and rituximab compared to placebo plus lenalidomide and rituximab
Overall response rate
More people treated with ADCETRIS plus lenalidomide and rituximab saw their cancer get smaller or become undetectable compared to those receiving placebo plus lenalidomide and rituximab
What safety information should I know about ADCETRIS?
The most important serious safety information
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): Patients treated with ADCETRIS can have a rare, serious brain infection called PML that can lead to death. Tell your doctor immediately if you have mood or behavior changes, confusion, problems in thinking or loss of memory, changes in vision, speech, or walking, or decreased strength or weakness on one side of the body. PML may also be caused by prior treatments or diseases that weakened your immune system.
These are not the only side effects of ADCETRIS. Always tell your doctor about any side effects you experience.
Most common side effects while taking ADCETRIS plus lenalidomide and rituximab
In people treated with ADCETRIS plus lenalidomide and rituximab, the most common side effects that occurred in ≥20% of study patients were feeling tired (46%), diarrhea (31%), nerve damage (peripheral neuropathy; PN) (27%), COVID-19 (27%), pneumonia (27%), rash (27%), and kidney problems (20%).
The most common serious side effects that occurred in >2% of study patients were pneumonia (21%), COVID-19 (13%, includes COVID-19 pneumonia), sepsis (9%), significantly low numbers of white blood cells with a fever (7%), hemorrhage (3.6%), urinary tract infection (3.6%), low blood platelet count (2.7%), and upper respiratory tract infection (2.7%).
The most common laboratory abnormalities that occurred in ≥30% of study patients were a decrease in white blood cells, a decrease in platelets, a decrease in hemoglobin, an increase in an enzyme called alanine aminotransferase (ALT), and a decrease in potassium.
For more information on side effects, please see the Important Safety Information at the bottom of this page and read the Important Facts about ADCETRIS, including BOXED WARNING.
Tell your doctor about any side effect concerns you have
Your doctor should prescribe granulocyte colony-stimulating factor (G-CSF) along with your ADCETRIS treatment right at the start. G-CSF is a medication that may help reduce the chance of neutropenia (low white blood cell count).
Don’t stop, change, or delay your ADCETRIS plus lenalidomide and rituximab treatment unless directed by your doctor. Your doctor may take additional steps to help manage side effects, including:
- Reducing your ADCETRIS dosage, or delaying your next dose, until symptoms improve
- Stopping ADCETRIS completely if side effects are severe or do not improve
For more information about understanding side effects, download a copy of the ADCETRIS side effects guide
Learn more about what you can expect before starting ADCETRIS treatment.
Glossary
G-CSF: Granulocyte colony-stimulating factor, a medication that can help boost white blood cell count.
Median: The middle number in a list of numbers.
Neutropenia: Having low levels of a type of white blood cell called neutrophils that help your immune system. You could have a higher chance of getting an infection.
Overall response rate: The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time. Measuring the overall response rate is one way to see how well a new treatment works.
Overall survival: The length of time that patients remain alive after starting study treatment.
Peripheral neuropathy: Nerve damage that can cause numbness or tingling in the hands or feet (sensory) and/or weakness in the arms or legs (motor).
Placebo: A substance that does not contain medication and has no effect. In clinical studies, it looks the same and is given the same way as the medication being tested.
Refractory: When cancer does not respond or stopped responding to treatment.
Relapse: When cancer has returned after signs and symptoms of cancer had reduced or became undetectable.