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Genentech Says Phase III POLARIX Trial Of Polivy Plus R-CHP Meets Primary Endpoint

Genentech, a member of Swiss drug major Roche (RHHBY), announced that the pivotal Phase III POLARIX trial met its primary endpoint in people with previously untreated diffuse large B-cell lymphoma or DLBCL.

The trial investigated Polivy (polatuzumab vedotin) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) versus Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone or R-CHOP.

The trial demonstrated significantly improved and clinically meaningful progression-free survival in people with previously untreated DLBCL.

According to the company, the phase III study shows 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.

The safety outcomes were consistent with those seen in previous trials.

Currently, Polivy is used as an off-the-shelf, fixed-duration treatment option in the relapsed or refractory (R/R) DLBCL setting, and is approved in combination with bendamustine and Rituxan for the treatment of R/R DLBCL in more than 60 countries worldwide, including in the EU and in the U.S.

Levi Garraway, chief medical officer and head of Global Product Development, "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. This Polivy regimen is the first in two decades to improve progression-free survival in DLBCL compared to the standard of care..."

The POLARIX results will be presented at an upcoming medical meeting and submitted to health authorities.

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