Roche’s Polivy Combination Approved by European Commission for People With Previously Untreated Diffuse Large B-cell Lymphoma

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that 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).

DLBCL is an aggressive blood cancer and the most common form of non-Hodgkin lymphoma.² Each year in Europe, it is estimated that 40,000 people are diagnosed with DLBCL.³ While many patients are responsive to initial treatment, four out of ten are not cured with the current standard of care, and the majority of people who require subsequent lines of therapy have poor outcomes.^4,5 Most DLBCL relapses occur within 24 months of starting treatment and patients who remain progression-free 24 months following initiation of first-line therapy have favourable survival outcomes.⁴

“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, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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 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,” said Professor Hervé Tilly, POLARIX Principal Investigator and Professor of Haematology at the University of Rouen. “Treatment with this regimen has been shown to reduce the chance of relapse and therefore need for subsequent treatments, limiting the burden of DLBCL.”

Today’s EC 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% 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% confidence interval [CI]: 0.57–0.95; P<0.0177).⁶ 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%), nausea (41.6%), neutropenia (38.4%), and diarrhoea (30.8%).⁶ Results were presented for the first time in December 2021 at the 63rd American Society of Hematology Annual Meeting & 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 today’s 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.