by Dr. C.H. Weaver M.D. 12/2021
The U.S. Food and Drug Administration initially granted accelerated approval to Polivy (polatuzumab vedotin), in combination with the chemotherapy Treanda (bendamustine) and Rituxan (rituximab) (a combination known as "BR"), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies and are not candidates for high dose chemotherapy and stem cell transplant. Pivotal trial results suggest that a Polivy based treatment regimen may also become the new standard of care for the initial treatment of DLBCL.1,2
About diffuse large B-cell lymphoma (DLBCL)
DLBCL is the most common form of non-Hodgkin lymphoma (NHL) and is diagnosed in approximately 150,000 people annually. DLBCL is curable with initial treatment using R-CHOP chemotherapy and Rituxan maintenance but as many as 40% of patients will ultimately relapse or have refractory disease.
About Polivy® (polatuzumab vedotin)
Polivy is a novel antibody-drug conjugate, that combines an antibody which binds to a specific protein (called CD79b) found only on B cells with a chemotherapy drug that is released into the cancer cells upon binding. Polivy binds to CD79b on a lymhoma's B cells and kills these them through the delivery of the anti-cancer agent. According to Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Antibody-drug conjugates are an emerging class of targeted immunotherapies for cancer. This type of therapy, unlike traditional chemotherapy, is intended to target specific cells."
Polivy plus R-CHP - New Standard Of Care of DLBCL?
The pivotal phase III POLARIX clinical trial directly compared Polivy® in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) to the standard treatment of DLBCL consisting of Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) and found that R-CHP was superior in delaying cancer progression to R-CHOP in people with previously untreated DLBCL.3
These results, from the phase 3 POLARIX were reported at the Dec. 14, 2021 American Society of Hematology (ASH) Annual Meeting and Exposition. In POLARIX, 879 patients were treated with either six cycles of pola-R-CHP (440 patients) or R-CHOP (439 patients) and directly compared. After a median follow-up of 28.2 months, the relative risk of cancer progression, relapse, or death was 27% lower in the patients who received pola-R-CHP than in those on R-CHOP. While overall survival was equivalent between the two arms.
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The Polivy regimen is the first regimen in two decades to improve progression-free survival in DLBCL compared to the standard of care. Full data to become available soon.
Polivy in Recurrent DLBCL
The current standard of care for recurrent DLBCL is high dose chemotherapy and autologous stem cell transplant because it cures more patients than standard chemotherapy. Some patients however do not have access to a stem cell transplant or may to old to undergo the procedure. Polivy combined with BR represents a new treatment option for these patients.
Polivy was evaluated in a small clinical trial of 80 patients with relapsed or refractory DLBCL who were treated with BR with or without Polivy and directly compared. At the end of treatment, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone. Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 64% had had a response duration of at least six months and 48% responded 12 months or longer to treatment.
The most common side effects of Polivy plus BR were neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, fever, decreased appetite and pneumonia. Patients and health care professionals alike are also advised to monitor closely for infusion-related reactions. The FDA advises health care professionals to tell females of reproductive age to use effective contraception during treatment with Polivy and for three months after the last dose. Women who are pregnant or breastfeeding should not take Polivy because it may cause harm to a developing fetus or newborn baby.
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