Polatuzumab Vedotin-Based Regimen Improves Outcomes in Previously Untreated Diffuse Large B-Cell Lymphoma

New results from the phase 3 POLARIX trial have found that a polatuzumab vedotin (Polivy, Roche)-based treatment regimen significantly improved outcomes in patients with previously untreated diffuse large B-cell lymphoma (DLBCL), according to a press release from Roche.

This is the first regimen in 2 decades to show such significant improvements, according to Roche. Prolonging survival rates without disease advancement could be a major step forward for this patient population, 40% of whom currently relapse following disease progression.

POLARIX is an international phase 3, randomized, double-blind, placebo-controlled study. Researchers randomized 879 patients 1:1 into the 2 treatment arms. Polatuzumab vedotin is a first-in-class anti-CD79b antibody drug conjugate under investigation for the treatment of several types of non-Hodgkin lymphoma (NHL).

The CD79b protein is expressed in the majority of B-cells, which are impacted in some types of NHL and are therefore a potential target for therapeutic development. The drug binds to cancer cells such as CD79b and kills the cells by delivering an anti-cancer agent, according to the press release.

In the trial, polatuzumab vedotin was administered in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) and was compared with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). The trial met its primary endpoint by demonstrating significantly improved and clinically meaningful progression-free survival, with safety outcomes consistent with those seen in previous trials.

Full clinical results will be presented at an upcoming medical meeting and will be submitted to health authorities soon, Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in the press release.

“Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative,” Garraway said in the press release. “This Polivy regimen is the first in two decades to improve progression-free survival in DLBCL compared to the standard of care, and we look forward to sharing these results with health authorities to bring this important potential new treatment option to patients as soon as possible.”

Polatuzumab vedotin is currently used as an off-the-shelf, fixed-duration treatment for patients with relapsed or refractory DLBCL. It is also approved in combination with bendamustine and rituximab for the treatment of relapsed or refractory DLBCL.

REFERENCE

Phase III study shows Roche’s Polivy plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive form of lymphoma compared to standard of care. News release. Roche; August 9, 2021. Accessed August 9, 2021. https://www.roche.com/media/releases/med-cor-2021-08-09.htm