Polatuzumab vedotin plus R-CHP is the first regimen in 20 years to significantly improve outcomes in patients with previously untreated diffuse large B-cell lymphoma compared to standard of care
The pivotal phase III POLARIX trial investigating Polatuzumab vedotin ( Polivy ) in combination with Rituximab ( MabThera / Rituxan ) plus Cyclophosphamide, Doxorubicin and Prednisone ( R-CHP ) versus Rituximab plus Cyclophosphamide, Doxorubicin, Vincristine and Prednisone ( R-CHOP ), met its primary endpoint by demonstrating significantly improved and clinically meaningful progression-free survival in people with previously untreated diffuse large B-cell lymphoma ( DLBCL ). 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 Rituximab for the treatment of R/R DLBCL in more than 60 countries worldwide, including in the EU and in the US.
In POLARIX, 879 patients were randomised 1:1 to receive either Polatuzumab vedotin plus R-CHP plus a Vincristine placebo for six cycles, followed by Rituximab for two cycles; or R-CHOP plus a Polatuzumab vedotin placebo for six cycles, followed by two cycles of Rituximab.
The primary outcome measure is progression-free survival as assessed by the investigator using the Lugano Response Criteria for malignant lymphoma.
Polivy is a first-in-class anti-CD79b antibody-drug conjugate ( ADC ). The CD79b protein is expressed specifically in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin lymphoma ( NHL ), making it a promising target for the development of new therapies.
Polatuzumab vedotin binds to cancer cells such as CD79b and kills these B-cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells.
Diffuse large B-cell lymphoma is the most common form of non-Hodgkin lymphoma, accounting for about one in three cases of NHL.
DLBCL is an aggressive type of NHL. While it is generally responsive to treatment in the frontline, as many as 40% of patients will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.
Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year. ( Xagena )
Source: Roche, 2021