SOUTH SAN FRANCISCO (dpa-AFX) - Roche Holding AG (RHHBY) on Monday said it presented updated data from the late-stage POLARIX study of Polivy in people with previously untreated diffuse large B-cell lymphoma, at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition.
POLARIX is a phase 3 study evaluating the efficacy, safety and pharmacokinetics of Polivy (polatuzumab vedotin) plus MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP) versus rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL).
Updated data from the POLARIX study continue to demonstrate a statistically significant reduction in the risk of disease worsening or death for people with previously untreated diffuse large B-cell lymphoma, the company said.
Further, patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes, during and after fixed-duration treatment, to those receiving the current standard-of-care, with superior progression-free survival.
Polivy in combination with R-CHP has been approved for the treatment of adult patients with previously untreated DLBCL in countries including the EU, Japan and Canada.
The company's supplemental Biologics License Application has already been accepted by the FDA, and a decision is expected by 2 April, 2023.
Copyright(c) 2022 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2022 AFX News
