Polivy combination (R-CHP) reduced the risk of disease worsening or death by 27%.
Safety outcomes were consistent with those seen in previous trials, and the safety profile was comparable for Polivy plus R-CHP versus R-CHOP. Results were presented as a late-breaking abstract and during a press briefing at the American Society of Hematology (ASH) Annual Meeting & Exposition on Tuesday, December 14, 2021. Data from POLARIX were simultaneously published in the New England Journal of Medicine (NEJM).
First efficacy and safety data from the pivotal Phase III POLARIX study showed a significant improvement in PFS with Polivy plus R-CHP versus R-CHOP in patients with previously untreated DLBCL after a median follow-up of 28.2 months (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; p<0.02). pfs is a clinically meaningful disease-related outcome for patients with previously untreated dlbcl as it represents the goals of first-line therapy: avoiding disease relapse, disease progression and death. the safety profile was comparable for polivy plus r-chp versus r-chop, including rates of grade 3-4 adverse events (aes; 57.7% versus 57.5%), serious aes (34.0% versus 30.6%), grade 5 aes (3.0% versus 2.3%), and aes leading to dose reduction (9.2% versus 13.0%). the polarix data form the basis of ongoing marketing applications to global health authorities.
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 70 countries worldwide, including in the EU and in the United States. Genentech continues to explore areas of unmet need where Polivy has the potential to deliver benefit, with ongoing studies investigating combinations of Polivy with the CD20xCD3 T-cell engaging bispecific antibodies mosunetuzumab and glofitamab, with Venclexta (venetoclax), which is being developed by AbbVie and Genentech, and with Rituxan in combination with gemcitabine and oxaliplatin in the Phase III POLARGO study.
“As many as 40% of people with this aggressive lymphoma experience a return of their cancer after initial therapy, at which point they face a poor prognosis and limited treatment options,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “This Polivy-based regimen may conceivably change the disease course for many people with DLBCL, so we are working with health authorities around the world to make this important, potential new treatment option available as soon as possible.”
See-"Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma"- H. Tilly and Others 10.1056/NEJMoa2115304.
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