(BPT) - Roy Bragadeste, a husband and father, was living in Seattle and enjoying what many would describe as a relatively normal life, working, spending time with his wife, kids and dog, and enjoying the outdoors. The idea of a cancer diagnosis was far from his mind, but that is exactly what happened.
During an epic storm blanketing Seattle with more snow than the city had seen in decades, Roy slipped and fell on a patch of ice, cracking three ribs. After experiencing severe pain for months from the broken ribs, he was examined by a doctor who pushed on his abdomen, causing Roy to call out in pain. Concerned that Roy shouldn't be experiencing discomfort there, the doctor recommended that Roy undergo a CT scan, which showed a mass in his pelvis. Roy also had swollen lymph nodes, a common symptom of what would turn out to be an aggressive type of blood cancer called diffuse large B-cell lymphoma (DLBCL).
After undergoing a lymph node biopsy, Roy was diagnosed with this cancer of the lymphatic system, which occurs when abnormal white blood cells grow out of control.1 DLBCL is the most common type of non-Hodgkin's lymphoma, responsible for approximately 31,000 new cases in the United States this year.2
Long before Roy moved to Seattle, he came to the United States from Portugal as an eight-year-old. His father, who did not yet speak English, worked three jobs, struggling to make ends meet. To help out his family, Roy started working at age 11, watering his neighbors' yards for 75 cents each.
Helping support his family at a young age taught Roy determination and resilience, traits that would be important years later - not only when he was diagnosed with DLBCL but again when his cancer relapsed, not once but three times.
Facing the Challenge of a Lymphoma Diagnosis
DLBCL is a fast-growing blood cancer and one of the most aggressive types of non-Hodgkin's lymphoma.3 For many people diagnosed with DLBCL, their cancer typically goes into remission with standard initial therapy. However, for 40% of them, their cancer either relapses (returns at a later time) or is refractory (doesn't respond to initial treatment).4
Although Roy had advanced-stage DLBCL, his oncologist told him it was treatable.
'It took a few weeks to accept my diagnosis and see myself as a cancer patient in the fight of my life,' Roy said.
He was initially treated with a combination of chemotherapy plus immunotherapy, persevering through six cycles of therapy.
Roy was then referred to a hematologist at the Swedish Cancer Institute in Seattle who is a lymphoma specialist and received radiation treatment.
Experiencing the Burden of Relapse
When a PET scan showed Roy's cancer had returned, the next step in his treatment journey was a bone marrow transplant.
'It was as close as I've ever been to saying 'this is it, I'm done,'' Roy said, referring to his experience undergoing the bone marrow transplant.
Six months after returning home from the hospital from the bone marrow transplant, Roy felt pain in his hip and couldn't lift his leg. His hematologist gave him the unfortunate news that the cancer had returned a second time. Roy elected to be treated with a type of cancer therapy in which immune cells were removed from his blood, genetically modified in a lab, and reinfused - which involved a week-long hospital stay.
Three months later, a scan showed a spot in Roy's lungs, and biopsy results revealed the cancer had returned a third time.
'Every time I heard I had cancer again, it was just as bad as the first time I heard it,' Roy said.
Roy was worried he was out of options, but he followed his hematologist's suggestion to enroll in a clinical trial evaluating an investigational treatment - a bispecific antibody, designed to utilize the immune system to fight lymphoma - for adults with DLBCL that has come back or did not respond to at least two previous treatments. It may also affect healthy cells.
'After I experienced a third relapse, I wanted to participate in a clinical trial. Even if the study wasn't successful, I wished to give back by using my condition to help hematologists and researchers advance investigational therapies that might help other people in a similar situation,' Roy said.
Based on the clinical trial results, the Food and Drug Administration (FDA) approved the treatment, Columvi® (glofitamab-gxbm), under accelerated approval in June 2023 for adults with certain types of relapsed or refractory DLBCL or large B-cell lymphoma (LBCL) after at least two previous rounds of cancer therapy. All medicines have side effects. In the clinical trial of Columvi, a serious side effect that was common was cytokine release syndrome, a type of inflammation throughout the body that can be severe and life-threatening.
For people like Roy with aggressive lymphoma who have relapsed several times and have limited treatment options, Columvi may provide hope.
Columvi is what's known as a fixed-duration treatment, meaning it's given for a finite number of treatment cycles, which may allow patients to have time off therapy after completing treatment, rather than continuous therapy, which is given until the cancer progresses. Columvi is ready for infusion, so treatment may be able to start soon after the medicine is prescribed.
After Roy's long treatment journey, he is now in remission. Today, he enjoys participating in outdoor activities and coaching baseball, and is focused on spending time with his family.
'Having blood cancer has been devastating, but it's also been a blessing,' he explained. 'It's given me the opportunity to live like I was dying. I got a kick in the butt that told me to wake up!'
If you or a loved one has DLBCL, talk to your doctor about treatment options. For more information about Columvi, visit https://www.columvi.com/.
This sponsored article is presented by Genentech.
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Columvi U.S. Indication
Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer.
It is not known if Columvi is safe and effective in children.
The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.
What is the most important information I should know about Columvi?
Columvi can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death.
Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including:
- fever of 100.4°F (38°C) or higher
- chills or shaking
- fast or irregular heartbeat
- dizziness or light-headedness
- trouble breathing
- shortness of breath
Due to the risk of CRS, you will receive Columvi on a 'step-up dosing schedule'.
- A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1).
- You will start the Columvi step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller 'step-up' doses of Columvi on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose.
- You will receive your first full dose of Columvi a week after the second step-up dose (this will be Day 1 of Cycle 2).
- If your dose of Columvi is delayed for any reason, you may need to repeat the 'step-up dosing schedule'.
- If you had more than mild CRS with your previous dose of Columvi, you should be hospitalized during and for 24 hours after receiving your next dose of Columvi.
- Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions.
Your healthcare provider will monitor you for CRS during treatment with Columvi 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 Columvi if you have severe side effects.
Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away.
What are the possible side effects of Columvi?
Columvi may cause serious side effects, including:
- Cytokine Release Syndrome.
- Neurologic problems. Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. 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, including:
- headache
- confusion and disorientation
- difficulty paying attention or understanding things
- trouble speaking
- sleepiness
- memory problems
- numbness, tingling, or weakness of the hands or feet
- dizziness
- shaking (tremors)
- Serious Infections. Columvi can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your health care provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat.
- Growth in your tumor or worsening of tumor related problems (tumor flare). Tell your healthcare provider if you get any of these signs or symptoms of tumor flare:
- tender or swollen lymph nodes
- pain or swelling at the site of the tumor
- chest pain
- cough
- trouble breathing
The most common side effects of Columvi include: CRS, muscle and bone pain, rash, and tiredness.
The most common severe abnormal lab test results with Columvi include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).
Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects.
Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection
- have kidney problems
- are pregnant or plan to become pregnant. Columvi may harm your unborn baby
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment with Columvi.
- You should use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi.
- are breastfeeding or plan to breastfeed. Columvi may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi.
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 Columvi?
Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.
These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi.
You may report side effects to the FDA at (800) FDA-1088 or http://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 Columvi full Prescribing Information and Medication Guide or visit https://www.Columvi.com.
References
- American Society of Clinical Oncology. Cancer.Net. Lymphoma - Non-Hodgkin: Introduction. https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/introduction. Accessed June 28, 2023.
- Kanas G, Ge W, Quek RGW, Keeven K, Nersesyan K, Arnason JE. Epidemiology of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in the United States and Western Europe: population-level projections for 2020-2025. Leuk Lymphoma. 2022;63(1):54-63. https://doi.org/10.1080/10428194.2021.1975188. Epub 2021 Sep 11. PMID: 34510995. Accessed June 28, 2023.
- American Cancer Society. About Non-Hodgkin Lymphoma. What Is Non-Hodgkin Lymphoma? https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html. Accessed June 28, 2023.
- Sawalha Y. Relapsed/refractory diffuse large B-cell lymphoma: a look at the approved and emerging therapies. J Pers Med. 2021;11(12):1345. https://doi.org/10.3390/jpm11121345. Accessed June 28, 2023.
- Columvi (glofitamab-gxbm) Prescribing Information. Genentech, Inc. 2023.
