How is MONJUVI unique?
MONJUVI is not chemotherapy, which makes it different from some of the other DLBCL treatments you may have taken or read about.
MONJUVI is targeted immunotherapy, which means it helps the immune system find and kill cancerous cells. Because of the way MONJUVI works with your immune system, treatment is given on a long-term basis to help you achieve and maintain control of your disease.
“It’s fascinating that you can take something that makes your own cells fight the cancer.”
—Gloria, living with DLBCL
B cells are part of a person’s immune system. They help your body fight infection. In DLBCL, B cells grow out of control, both in size and number. MONJUVI targets cancerous B cells directly and activates your immune system to fight relapsed or refractory DLBCL. MONJUVI can also affect healthy cells. The images below show how MONJUVI works.
1
Cancerous B cell with CD19 markers.
2
MONJUVI locates and binds
to the CD19 marker on the surface
of cancerous B cells.
3
This binding action triggers
immune cells to kill the cancer cells.
Results from a clinical study
A clinical study of MONJUVI and lenalidomide showed results from people who reached remission
In the first analysis,* 55% of people (39 out of 71) reached either complete or partial remission.
37% of people reached complete remission, the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured.
18% of people reached partial remission, a decrease (usually at least 50% in DLBCL) in the size of a tumor, or in the extent of cancer in the body, in response to treatment.
How your condition progresses and how you may respond to MONJUVI depends on your individual circumstances.
The combination of MONJUVI and lenalidomide was studied in 71 people whose DLBCL came back, got worse, or didn’t respond to treatment and who could not receive a stem cell transplant. They received this treatment for up to 12 cycles. Then they were given MONJUVI alone.
In the later analysis, a similar number of people who received MONJUVI and lenalidomide reached either complete or partial remission.
MONJUVI, in combination with lenalidomide, was approved by the US Food and Drug Administration (FDA) based on results from the first analysis.
The FDA has not reviewed results from the later analysis, and these results are not included in the final FDA-approved Prescribing Information.
*People in this study had several follow-up visits with their doctor to see how their treatment was going. Results from these visits were measured at two points in time: 12 months (first analysis) and 35 months (later analysis) after the last patient started treatment.
For people in the study who reached remission, results showed how long remission lasted
The people who reached remission with MONJUVI and lenalidomide were also studied to see how long they stayed in complete or partial remission. This is known as the duration of response.
The median duration of response is the length of time that half of the people continued to stay in remission at the time the study analysis was done. This means they were living without their cancer growing or spreading.
MEDIAN DURATION OF RESPONSE
In the study, half of the people who responded to treatment were likely to continue to stay in remission for:
About 2 yearsin the first analysis
More than 3.5 years in the later analysis
These results are based on 39 out of 71 people who responded during the first analysis and 38 people who responded during the later analysis.
MONJUVI, in combination with lenalidomide, was approved by the US Food and Drug Administration (FDA) based on results from the first analysis.
The FDA has not reviewed results from the later analysis, and these results are not included in the final FDA-approved Prescribing Information.
Please consult your healthcare team if you have any questions about this study information. Remember, your healthcare team is the single best source of medical advice regarding your treatment.
Learn more about how you will receive MONJUVI and your treatment schedule.