What Are Treatment Goals for 3L+ FL?

There is no cure for FL. However, based on your experience with FL, you may have different treatment goals, such as: Achieving remission (disappearance of signs and symptoms) Maintaining remission Discuss your treatment goals with your doctor If your doctor has concluded that your FL is relapsed or refractory to at least 2 prior treatments, you may be a candidate for an innovative option: bispecific antibody treatment.

What Is Bispecific Antibody Treatment?

Antibody treatment is designed to find and destroy specific cells within the body. This therapy is an important part of FL treatment plans. It can also harm healthy cells in the body.

About follicular lymphoma

Q: What Is Follicular Lymphoma?

Follicular lymphoma (FL) is a form of non-Hodgkin’s Lymphoma (NHL), a blood cancer that involves white blood cells. White blood cells help fight infections. However, unhealthy white blood cells can build up in the lymph nodes, bone marrow, and spleen (see picture). FL can be a life-long disease. FL is the most common type of slow-growing NHL.

Follicular lymphoma (FL) is a form of non-Hodgkin lymphoma (NHL), a blood cancer that involves white blood cells.

White blood cells help fight infections. However, unhealthy white blood cells can build up in the lymph nodes, bone marrow, and spleen (see picture below).

FL can be a life-long disease. FL is the most common type of slow-growing NHL.

What does third-line or later (3L+) FL mean?

3L+ FL means that after at least 2 prior treatments, your FL has relapsed (returned) or is refractory (has not responded to treatment).

What can 3L+ FL look like?

Understanding FL that has returned or has not responded to treatment

When your FL has not responded or has returned following 2 treatments, symptoms may be similar to ones you have experienced before, but they can vary from patient to patient.

You and your doctor can look for some of these possible symptoms:

Swelling in your lymph nodes, liver, or spleen

An increase in the number of abnormal white blood cells

A decrease in the number of normal blood cells

Fever, fatigue, and night sweats

Unexplained weight loss

Severe or frequent infections

Easy bruising or bleeding

Numbness or tingling in feet and/or hands

Headaches and/or blurry vision

Symptoms of FL may be seen in other conditions as well. Only your doctor will be able to tell if your symptoms are related to FL.

While you are being treated and after your treatment stops, your doctor will continue to monitor your FL in order to decide how best to take care of it

This may include routine tests, such as physical exams, blood cell counts, and bone marrow biopsies to identify the sources of symptoms

Be sure to discuss symptoms with your doctor to understand when treatment is right for you

NEXT: Treatment goals for 3L+ FL

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What is LUNSUMIO?

LUNSUMIO (mosunetuzumab-axgb) is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer.

It is not known if LUNSUMIO is safe and effective in children.

The conditional approval of LUNSUMIO is based on response rate. There are ongoing studies to establish how well the drug works.

What is the most important information I should know about LUNSUMIO?

LUNSUMIO may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO, and can also be severe or life-threatening.

Get medical help right away if you develop any signs or symptoms of CRS at any time, including:

fever of 100.4°F (38°C) or higher
chills
low blood pressure
fast or irregular heartbeat
tiredness or weakness
difficulty breathing
headache
confusion
feeling anxious
dizziness or light-headedness
nausea
vomiting

Due to the risk of CRS, you will receive LUNSUMIO on a “step-up dosing schedule.”

The step-up dosing schedule is when you receive smaller “step-up” doses of LUNSUMIO on Day 1 and Day 8 of your first cycle of treatment
You will receive a higher dose of LUNSUMIO on Day 15 of your first cycle of treatment
If your dose of LUNSUMIO is delayed for any reason, you may need to repeat the step-up dosing schedule
Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS

Your healthcare provider will check you for CRS during treatment with LUNSUMIO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO, if you have severe side effects.

What are the possible side effects of LUNSUMIO?

LUNSUMIO may cause serious side effects, including:

neurologic problems. LUNSUMIO can cause serious and life-threatening neurological problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with LUNSUMIO, including:
- headache
- numbness and tingling of the arms, legs, hands, or feet
- dizziness
- confusion and disorientation
- difficulty paying attention or understanding things
- forgetting things or forgetting who or where you are
- trouble speaking, reading, or writing
- sleepiness or trouble sleeping
- tremors
- loss of consciousness
- seizures
- muscle problems or muscle weakness
- loss of balance or trouble walking
- tiredness
serious infections. LUNSUMIO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LUNSUMIO, including:
- fever of 100.4°F (38°C) or higher
- cough
- chest pain
- tiredness
- shortness of breath
- painful rash
- sore throat
- pain during urination
- feeling weak or generally unwell
hemophagocytic lymphohistiocytosis (HLH). LUNSUMIO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with LUNSUMIO. Your health care provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
- fever
- enlarged spleen
- easy bruising
- low blood cell counts
- liver problems
low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO. LUNSUMIO can cause the following low blood cell counts:
- low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection
- low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
- low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems
growth in your tumor or worsening of tumor related problems (tumor flare). LUNSUMIO can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with LUNSUMIO:
- chest pain
- cough
- trouble breathing
- tender or swollen lymph nodes
- pain or swelling at the site of the tumor

Your healthcare provider may temporarily stop or permanently stop treatment with LUNSUMIO if you develop severe side effects.

The most common side effects of LUNSUMIO include: tiredness, rash, fever, and headache.
The most common severe abnormal blood test results with LUNSUMIO include: decreased phosphate, increased glucose, and increased uric acid levels.

Before receiving LUNSUMIO, tell your healthcare provider about all of your medical conditions, including if you:

have ever had an infusion reaction after receiving LUNSUMIO
have an infection, or have had an infection in the past which lasted a long time or keeps coming back
have or have had Epstein-Barr Virus
are pregnant or plan to become pregnant. LUNSUMIO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO
Females who are able to become pregnant:
- your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO
- you should use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO
are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving LUNSUMIO?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

These are not all the possible side effects of LUNSUMIO. Talk to your health care provider for more information about the benefits and risks of LUNSUMIO.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the LUNSUMIO full Prescribing Information and Medication Guide.

B cell

A type of white blood cell that makes antibodies. B cells are part of the immune system and develop from stem cells in the bone marrow. FL is a type of B-cell lymphoma.
Bispecific antibody

Bispecific antibodies are designed to target 2 different sites on different cells or the same cell. For example, a bispecific antibody binding to 2 different cells is thought to bring the cells together, such as an immune cell and cancer cell.
Bone marrow

The soft spongy material that fills the inside of bones. Bone marrow is the source of new blood cells, and platelets are made in the bone marrow.
Complete remission

Also called complete response—the disappearance of all signs of cancer in response to treatment. This does not mean the cancer has been cured.
Cytokine release syndrome (CRS)

A side effect where your immune system responds too strongly by rapidly releasing a large amount of substances known as cytokines. It may cause fever, nausea, or other symptoms.
Cycle

A period of treatment followed by a period of rest (no treatment) that is repeated on a regular schedule.
Follicular lymphoma

The most common type of indolent (slow-growing) non-Hodgkin lymphoma (NHL). With NHL, abnormal lymphocytes (white blood cells) build up in the lymph nodes, bone marrow, and spleen. FL develops when the body makes abnormal B lymphocytes, making it a type of B-cell lymphoma. FL can be a chronic disease.
Lymph nodes

Small bean-shaped organs that store white blood cells.
Non-Hodgkin lymphoma

A type of cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. FL is a type of non-Hodgkin lymphoma.
Overall response

A partial or complete remission.
Partial remission

Also called partial response—some measurable decrease in size of the cancer.
Phase 2 clinical trial

A type of clinical trial that studies an investigational treatment to test how well it works and monitors for potential side effects.
Refractory

A term used to describe disease that has not responded to previous treatment.
Relapsed

A term used to describe disease that has returned after responding to previous treatment.
Remission

A term used to describe a response to treatment.
Spleen

An organ that is part of the lymphatic system. The spleen makes lymphocytes (white blood cells), filters blood, stores blood cells, and destroys old blood cells. It is located on the left side of the abdomen near the stomach.
Step-up dose

A smaller dose of LUNSUMIO that you receive on Day 1 and Day 8 of your first cycle of treatment.
T cell

A type of white blood cell. T cells are part of the immune system, helping to protect the body from infection and may also help fight cancer. A subset, cytotoxic T cells, bind to and kill infected cells and cancer cells.