FDA Approves Genentech’s Polivy in Combination with R-CHP for Certain Types of Previously Untreated Diffuse Large B-Cell Lymphoma

Rare Daily Staff

The U.S. Food and Drug Administration expanded the label for Genentech’s Polivy, approving it in combination with Rituxan, cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma and who have an International Prognostic Index score of two or greater.

This FDA decision also converts the accelerated approval of Polivy in combination with bendamustine and Rituxan for relapsed or refractory diffuse large B-cell lymphoma after at least two prior therapies to regular approval.

Diffuse large B-cell lymphoma (DLBCL) is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin’s lymphoma in the United States. Approximately 31,000 people in the U.S. are projected to be diagnosed with DLBCL in 2023. While many patients are responsive to initial treatment, as many as four in 10 people with DLBCL do not respond or relapse. For people who undergo initial treatment with the standard of care, Rituxan plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), most relapses occur within two years of starting treatment, and the majority of those who require subsequent lines of therapy have poor outcomes.

Genentech, a member of the Roche Group, says first-line treatment with Polivy plus R-CHP has the potential to reduce the burden on patients and healthcare systems, associated with disease progression.

“It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma,” said Levi Garraway, chief medical officer and head of Global Product Development at Roche. “Today’s decision from the FDA to approve Polivy in combination with R-CHP (Rituxan, cyclophosphamide, doxorubicin, and prednisone) in this setting brings a much-needed new treatment option which may improve outcomes and bring other benefits to many patients with this aggressive lymphoma.”

The FDA approval of Polivy plus R-CHP for the first-line treatment of DLBCL is based on pivotal data from POLARIX, an international phase 3, randomized, double-blind, placebo-controlled study that demonstrated a statistically significant and clinically meaningful improvement in progression free survival compared to R-CHOP. The risk of disease progression, relapse or death was reduced by 27 percent with Polivy plus R-CHP compared with R-CHOP. The safety profile was comparable for Polivy plus R-CHP versus R-CHOP. The most common adverse events were peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. The most common Grade 3-4 adverse events were lymphopenia and neutropenia.

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Seagen ADC technology and is currently being investigated for the treatment of several types of non-Hodgkin’s lymphomas.

More than 70 countries have already approved Polivy in combination with R-CHP for the treatment of adult patients with previously untreated DLBCL, including in the European Union, United Kingdom, Japan, Canada, and China.

Photo: Levi Garraway, chief medical officer and head of Global Product Development at Roche