Finding new hope with an innovative immunotherapy for blood cancer
Sponsored by and provided by Genentech, a member of the Roche Group
Each year in the United States, approximately 16,000 people are diagnosed with follicular lymphoma (FL) [1], the most common slow-growing form of non-Hodgkin's lymphoma (NHL). [2] People with this blood cancer often experience periods of remission and relapse, and the disease can become more difficult to treat each time it relapses. [3]
Juan Yee, a married father of three and a postal worker in San Diego, knows first-hand what it is like to be diagnosed with FL and experience relapses. He was living an active life, going to professional baseball games and enjoying jet skiing and other activities with his sons, but began experiencing swollen lymph nodes and fatigue. He brushed the symptoms off, explaining, "I was trying to be strong and kept working a lot, but then my appetite disappeared, I felt weak, and I was having night sweats."
Lab tests revealed that Yee had FL. While not everyone responds to treatment, Yee is in remission today because of multiple treatments including one innovative cancer therapy.
Experiencing his third bout of blood cancer
At the time of Yee's initial diagnosis, he was treated with chemotherapy, which caused many side effects, including constipation, heartburn and hair loss. "I was 38 years old. My three sons were still young, so it was scary. But I tried to be positive, and my whole family really supported me," says Yee.
Several years later, Yee again noticed swollen lymph nodes and fatigue, as well as weight loss and night sweats that wouldn't go away. With this first relapse, he was again treated with chemotherapy.
Just two years later, Yee's cancer returned yet again. For this third bout of blood cancer, his doctor recommended a stem cell transplant that would require preparation with chemotherapy. Feeling like he was at the end of his rope, Yee decided not to undergo any treatment. "I couldn't go through chemo again. I was done. I didn't want to put my family through all that," he explains.
Deciding to participate in a clinical trial
Yee's sister told him about a celebrity she had seen on television who was celebrating being cancer-free five years after battling the same cancer Yee had, though this person received a different treatment. That inspired renewed hope for Yee, and he went back to see his oncologist, who had read about an experimental medicine being evaluated in a clinical trial and recommended Yee meet with Dr. Elizabeth Budde. An associate professor in the Division of Lymphoma at City of Hope, Dr. Budde was leading a clinical trial of an investigational medicine – mosunetuzumab-axgb.
"She explained to me how the medication is designed to work and that it would not require chemotherapy," says Yee.
Mosunetuzumab is a T-cell engaging bispecific antibody, a unique type of cancer immunotherapy for FL patients who have received two lines of previous therapy. This T-cell engaging bispecific antibody is designed to bind to proteins on T cells, immune cells that help detect foreign and abnormal cells, and B cells, which can be healthy or malignant. Once bound, the medicine redirects the T cells to engage and destroy B cells.
As Dr. Budde explains it, "The cells are pulled together, with mosunetuzumab serving as a kind of bridge. The idea is that being in such close proximity allows the now activated T immune cells to recognize the cancerous B cells and release cancer-killing proteins to eliminate them."
Yee decided to participate in the study because having the option of a different type of medicine – a therapeutic approach unlike ones he'd tried before that uses the patient's own immune system to fight cancer – was important to him.
Mosunetuzumab received accelerated approval from the U.S. Food and Drug Administration under the name Lunsumio® (mosunetuzumab-axgb) to treat adults with FL whose cancer has come back or did not respond to previous treatment and who have already received two or more treatments for their cancer. The conditional approval of Lunsumio is based on response rate. There are ongoing studies to establish how well the medicine works. Individual treatment experiences may vary.
The approval was based on findings from the clinical trial. Results showed that 80% of patients who received at least two previous therapies achieved either a disappearance of all signs and symptoms of cancer (complete remission) or a decrease in the amount of cancer in their body (partial remission). Among all study participants, 60% went into complete remission. The median duration of response to the medicine was 22.8 months. All medicines have side effects. In the study, the most common side effect with Lunsumio was cytokine release syndrome, a type of inflammation throughout the body that can be severe and life-threatening. Fatigue, rash, fever and headache were among other common side effects. [4]
"Thanks to the participation of Juan and other patients in the study, we now have a bispecific antibody treatment option to offer patients with follicular lymphoma whose disease has already relapsed twice," explains Dr. Budde. "This treatment offers patients who have received two prior treatments realistic hope for achieving a durable remission."
Sharing his experience
Patients continue to benefit from people like Yee who participate in clinical trials because these studies provide critical information for doctors and researchers. He is glad he participated in the study and now focuses on the activities he loves, such as volunteering at his church and spending time with his family, including his first grandson.
"When I was going through all those rounds of treatment, remission, relapse and more treatment, I kept asking God why this was happening to me," says Yee. "Now I think it was so I could help other people by sharing my experience and telling others to never give up."
For more information, visit Lunsumio.com.
[1] American Cancer Society: Cancer Facts and Figures 2023. American Cancer Society, 2023. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2023/2023-cancer-facts-and-figures.pdf. Accessed May 11, 2023.
[2] American Cancer Society. Types of B-cell lymphoma. https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html. Accessed February 22, 2023.
[3] Cahill KE, Smith SM. Follicular lymphoma: a focus on current and emerging therapies. Oncology. 2022;36(2):97-106.
[4] Genentech, Inc. 2022. Lunsumio (mosunetuzumab-axgb) Prescribing Information. https://www.gene.com/download/pdf/lunsumio_prescribing.pdf
Lunsumio U.S. Indication
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. 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
- 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
- Low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO and can also be severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO. LUNSUMIO may 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 may 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: tender or swollen lymph nodes, chest pain, cough, trouble breathing, and 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 lab 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 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.