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Phase 3 trial delivers a new treatment for most prevalent form of lymphoma

This antibody-drug combo reduces death risk in Patients with Diffuse Large B-Cell Lymphoma

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The POLARIX phase 3 trial has found an antibody-drug combo that reduces risk of disease growth and death by 27%

Research from the POLARIX trial found that pola-R-CHP reduces the risk of Diffuse Large B-Cell Lymphoma disease progression, relapse, or death by 27%

In patients with previously untreated Diffuse Large B-Cell Lymphoma (DLBCL), Polatuzumab vedotin with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (pola-R-CHP) resulted in a 27% reduction in the risk of disease progression or death, according to a study published today in the New England Journal of Medicine (NEJM).

“Diffuse Large B-Cell Lymphoma is the most prevalent form of lymphoma and one of the most common hematological malignances. Over the last two decades, there have been multiple attempts – albeit unsuccessful – to improve the cure rate of this disease either through modified dose, schedule of R-CHOP or by adding targeted agents to this regimen,” says Dr. Gilles Salles, MSK Chief.

“This study shows that R-CHP in combination with Polatuzumab vedotin significantly improves progression-free survival rates for patients with Diffuse Large B-Cell Lymphoma and results in a sizable reduction in the relapse risk after successful treatment completion, avoiding the use of salvage therapies that are often unsuccessful and associated with significant toxicity burden.”

For individuals with newly diagnosed DLBCL, R-CHOP is the current standard of therapy. R-CHOP, on the other hand, cures just 60 to 70% of patients, and many DLBCL patients recur after treatment. Patients with high-risk indicators, such as a high International Prognostic Index (IPI) score, are also more likely to have negative outcomes.

Polatuzumab vedotin is an antibody-drug combo that specifically targets CD79b, which is present on the surface of malignant B cells in abundance. The experiment, which was done at MSK and other international centers, compared the novel regimen to R-CHOP by substituting Polatuzumab vedotin for Vincristine.

The POLARIX trial – a Phase 3 double-blind, placebo-controlled study – randomized 879 patients aged 18–80 years with previously untreated intermediate or high-risk DLBCL 1:1 to receive six cycles of pola-R-CHP or R-CHOP plus two cycles of Rituximab alone. The primary endpoint was progression-free survival as determined by the investigator. Additionally, overall survival and safety were considered secondary goals.

After an average follow-up of 28.2 months, the two-year progression-free survival rate for pola-R-CHP was 76.7 % versus 70.2 %, significantly superior than R-CHOP. Overall survival was comparable between treatment arms, and the safety profile of pola-R-CHP and R-CHOP was comparable.

These findings justify the initial treatment of this similar-aged cohort with pola-R-CHP.

Image Credit: Getty

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