Polivy in combination with MabThera (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for adult patients with previously untreated DLBCL
Roche has received the European Commission (EC) approval for a combination therapy of its Polivy (polatuzumab vedotin) to treat a type of diffuse large B-cell lymphoma (DLBCL).
The combination, comprising Polivy, MabThera (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for adult patients with previously untreated DLBCL.
Polivy is an antibody-drug conjugate (ADC) that works against CD79b protein which is expressed specifically in the majority of B-cells.
It is said to bind to cancer cells and destroy the B-cells by delivering an anti-cancer agent, with minimal effects on the surrounding tissues and cells.
Roche is developing the drug leveraging Seagen ADC technology and is currently evaluating it for the treatment of various types of non-Hodgkin lymphoma (NHL).
Furthermore, EC extended Polivy’s previous marketing authorisation into a full approval, to treat relapsed or refractory DLBCL in adults who are not eligible for stem cell transplant.
Roche chief medical officer and global product development head Levi Garraway said: “After more than 20 years with very limited treatment advances, the approval of Polivy plus R-CHP marks a new era for people battling this aggressive disease.
“We are delighted that the European Commission has approved this Polivy regimen and believe it has the potential to make a significant impact on the lives of people with DLBCL.”
The EC approval was based on results from the Phase 3 POLARIX study, that evaluated the efficacy, safety and pharmacokinetics of Polivy combination in 879 DLBCL patients.
In the study, the drug combination showed a clinically meaningful improvement in progression free survival (PFS), compared to standard of care (SoC).
SoC includes rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP).
The study results showed a 27% reduction in the risk of disease worsening or death with Polivy plus R-CHP compared to R-CHOP in first-line DLBCL.
Also, it showed a comparable safety profile for Polivy plus R-CHP compared to R-CHOP.
Roche conducted POLARIX study in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC).
POLARIX Principal Investigator professor Hervé Tilly said: “The approval of Polivy plus R-CHP in the first-line setting is great news for people in the EU diagnosed with this aggressive lymphoma, giving them a greater opportunity for positive outcomes.
“Treatment with this regimen has been shown to reduce the chance of relapse and therefore need for subsequent treatments, limiting the burden of DLBCL.”