(BPT) - For hematologist-oncologist Dr. Amitkumar Mehta, his passion is to help develop approaches to treat lymphoma, including immunotherapies and targeted therapies that are effective and tolerable. As a clinical trial investigator and director of the Lymphoma and Immune Effector Cell Therapy Program at the University of Alabama at Birmingham O'Neal Comprehensive Cancer Center, the only National Cancer Institute-designated comprehensive cancer center in the state, Dr. Mehta has been treating people with lymphoma for more than a decade.
He decided to pursue a career in medicine because it represents a combination of science, compassion, service and human connection. He was attracted to hematology/oncology in particular because of the expanding understanding of cancer biology and immunotherapy and targeted treatment approaches.
'In hematology/oncology, we have seen impressive advances with the development of treatments, including antibody-drug conjugates, immunotherapies, bispecific antibodies and cell therapies,' said Dr. Mehta. 'The treatment of lymphoma has seen a paradigm shift, which has benefited patients with this type of blood cancer.'
Among Dr. Mehta's patients with lymphoma are those with diffuse large B-cell lymphoma (DLBCL), an aggressive, or fast-growing, blood cancer.
Typically, the therapy for people with DLBCL who have not previously been treated has involved a regimen that combines traditional chemotherapy with immunotherapy (chemoimmunotherapy). Although this standard treatment is effective for many people with DLBCL, about four in 10 will see their cancer either relapse (return after treatment), usually within two years, or not respond to treatment at all.1,2 At that point, people with DLBCL may require subsequent treatments, which exposes them to additional side effects.
That is why Dr. Mehta was excited when, in April 2023, the Food and Drug Administration (FDA) approved a first treatment for adults who have moderate to high risk DLBCL, not otherwise specified or high-grade B-cell lymphoma.
'Receiving a diagnosis of DLBCL is devastating news for my patients who often feel hopeless. Being able to offer them another treatment option is important to me and encouraging for them to hear,' said Dr. Mehta.
DLBCL Quick Facts
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A Major Step Forward in Treating Patients
Polivy® (polatuzumab vedotin-piiq; learn more about approved use and safety information) in combination with four other medicines called R-CHP for short - a rituximab product, cyclophosphamide, doxorubicin, and prednisone - is the first FDA-approved treatment since 2006 to delay the worsening or return of cancer in adults with certain types of newly diagnosed DLBCL.6
Polivy is what is known as an antibody-drug conjugate - it is made up of a monoclonal antibody linked to a chemotherapy. When Polivy is administered to patients, the monoclonal antibody attaches to a specific protein on dividing B cells, including those that are cancerous in DLBCL, and delivers the chemotherapy into the B cells to kill them. It also can affect some healthy cells.
'I am encouraged to be able to offer my patients newly diagnosed with this fast-growing and difficult-to-treat lymphoma a treatment option that may result in a positive outcome and that represents an important milestone in the DLBCL treatment landscape,' added Dr. Mehta.
The FDA approval of Polivy plus R-CHP was based on findings from an international late-stage trial in 879 patients with DLBCL who were randomly assigned to Polivy plus R-CHP or traditional chemoimmunotherapy. Neither the study participants or the study investigators knew who was receiving which treatment regimen (double-blind). Study results showed that Polivy plus R-CHP reduced patients' risk of dying or their cancer progressing or relapsing by 27% compared with the traditional chemoimmunotherapy in the intention-to-treat (ITT) population, which includes all patients who were randomized in the trial.7 The most common side effects among patients treated with Polivy were nerve problems in arms and legs, nausea, tiredness or lack of energy, diarrhea, constipation, hair loss and redness and sores of the lining of the mouth, lips, throat and digestive tract.6 Please see below for additional safety information.
Patients and Loved Ones Should Talk to Their Doctor
If you or a loved one has been newly diagnosed with DLBCL, talk to your doctor about available treatment options. For more information about Polivy plus R-CHP for the initial treatment of certain types of DLBCL, visit http://www.Polivy.com.
This sponsored article is presented by Genentech.
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Polivy U.S. Indication
Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL).
Important Safety Information
Possible serious side effects
Everyone reacts differently to POLIVY therapy, so it's important to know what the side effects are. Some people who have been treated with POLIVY have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.
- Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
- Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
- Low Blood Cell Counts: Treatment with POLIVY can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with POLIVY
- Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you POLIVY, which may prevent some infections
- Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
- Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
- Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication
Side effects seen most often
The most common side effects during treatment were
- Nerve problems in arms and legs
- Nausea
- Tiredness or lack of energy
- Diarrhea
- Constipation
- Hair loss
- Redness and sores of the lining of the mouth, lips, throat, and digestive tract
POLIVY may lower your red or white blood cell counts and increase uric acid levels.
POLIVY may not be for everyone. Talk to your doctor if you are
- Pregnant or think you are pregnant: Data have shown that POLIVY may harm your unborn baby
- Planning to become pregnant: Women should avoid getting pregnant while taking POLIVY. Women should use effective contraception during treatment and for 3 months after their last POLIVY treatment. Men taking POLIVY should use effective contraception during treatment and for 5 months after their last POLIVY treatment
- Breastfeeding: Women should not breastfeed while taking POLIVY and for 2 months after the last dose
These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of POLIVY treatment.
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 the full Prescribing Information for additional Important Safety Information.
References
1. 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 21, 2023.
2. Wang Y, Farooq U, Link BK, et al. Late relapses in patients with diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2019;37(21):1819-1827. https://doi.org/10.1200/JCO.19.00014. Accessed June 21, 2023.
3. 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 21, 2023.
4. National Cancer Institute. Surveillance, Epidemiology, and End Results Program (SEER). Cancer Stat Facts - NHL. Diffuse Large B-Cell Lymphoma (DLBCL). https://seer.cancer.gov/statfacts/html/dlbcl.html. Accessed June 21, 2023.
5. American Society of Clinical Oncology. Cancer.Net. Lymphoma - Non-Hodgkin: Symptoms and Signs. https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/symptoms-and-signs. Accessed July 28, 2023.
6. Polivy (polatuzumab vedotin-piiq) Prescribing Information. Genentech, Inc. 2023.
7. Tilly H, Morschhauser F, Sehn L, et al. Polatuzumab vedotin in previously untreated diffuse large B-cell lymphoma. N Engl J Med. 2022;386:351-363. https://www.nejm.org/doi/full/10.1056/NEJMoa2115304. Accessed July 12, 2023.
