European Commission approves Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma

The approval is based on pivotal data from the phase-III Polarix study, where Polivy plus R-CHP significantly improved Progression-Free Survival with comparable safety versus the standard of care, R-CHO

The European Commission (EC) has granted approval of Polivy (polatuzumab vedotin) in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients with previously untreated Diffuse Large B-Cell Lymphoma (DLBCL), Roche said yesterday in a statement.

“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,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head, Global Product Development, Roche, in the statement.

The statement further said that the approval was based on results from the phase-III Polarix study (GO39942), the first trial to show a clinically meaningful improvement in Progression-Free Survival (PFS), compared to standard of care rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), in people with previously untreated DLBCL. All patients were followed for at least 24 months and at a median follow-up of 28.2 months, results of the study showed a 27 per cent reduction in the risk of disease worsening or death with Polivy plus R-CHP compared to R-CHOP in first-line DLBCL (hazard ratio [HR] 0.73; 95 per cent confidence interval [CI]: 0.57-0.95; P<0.0177). The safety profile was comparable for Polivy plus R-CHP versus R-CHOP. The most frequently-reported (≥ 30%) adverse events with Polivy plus R-CHP were peripheral neuropathy (52.9 per cent), nausea (41.6 per cent), neutropenia (38.4 per cent) and diarrhoea (30.8 per cent). Results were presented for the first time in December 2021 at the 63rd American Society of Hematology Annual Meeting and Exposition, and simultaneously published in the New England Journal of Medicine. The Polarix study is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC).

In addition to this approval, the EC also converted Polivy’s initial conditional marketing authorisation in the EU for the treatment of adult patients with relapsed or refractory DLBCL, who are not candidates for a haematopoietic stem cell transplant, to a full approval. Roche continues to explore areas where Polivy has the potential to deliver additional benefit, including ongoing studies investigating combinations of Polivy with CD20xCD3 T-cell engaging bispecific antibodies in previously treated/untreated DLBCL, the statement concluded.

EU drug approvalPolarix studyPolivy combinationRoche
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