Roche today announced that new and updated data for its first-in-class anti-CD79b antibody-drug conjugate Polivy (polatuzumab vedotin) were presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, 10-13 December.

Data from the POLARIX study support the potential benefit of Polivy in combination with MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to improve outcomes for people with previously untreated diffuse large B-cell lymphoma (DLBCL).

“Too many patients with diffuse large B-cell lymphoma see their cancer relapse or progress after initial treatment. This highlights the need to improve on a standard-of-care that has remained unchanged for the last two decades,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “These updated POLARIX data indicate the potential benefits that this Polivy based-regimen could bring to people living with this aggressive type of lymphoma, and demonstrate our commitment to developing new treatment options.”

Based on the pivotal data from the POLARIX study, more than 50 countries have approved Polivy in combination with R-CHP for the treatment of adult patients with previously untreated DLBCL, including the EU, Japan and, most recently, Canada. The company's supplemental Biologics License Application was accepted by the U.S. Food and Drug Administration, and a decision is expected by 2 April, 2023. Polivy is currently approved in more than 80 countries and regions worldwide, including in the U.S. and Europe, as a readily available, fixed-duration treatment option for R/R DLBCL in combination with bendamustine and MabThera/Rituxan, after at least two prior therapies.

Roche continues to explore areas of unmet need where Polivy has the potential to deliver additional benefit, including in ongoing studies investigating combinations of Polivy with CD20xCD3 T-cell engaging bispecific antibodies, Lunsumio (mosunetuzumab) and glofitamab, including the phase III SUNMO study in combination with Lunsumio, and with MabThera/Rituxan in combination with gemcitabine and oxaliplatin in the phase III POLARGO study.