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For the first time, bolotolizumab plus R-CHP showed clinically significant progression-free survival improvement in patients with untreated diffuse large B-cell lymphoma compared with standard therapy, and the safety was comparable to that of standard therapy.
Key data from the POLARIX Phase III study showed a clinically significant improvement in progression-free survival compared to standard therapy in patients with untreated diffuse large B-cell lymphoma, and safety comparable to standard therapy, for the first time in 20 years. In patients with previously untreated large B-cell lymphoma, about 40% of patients do not recover after receiving current standard therapy and have a poor prognosis.
On March 25, 2022, Roche announced that the European Medicines Agency's Commission on Medicinal Products for Human Use (CHMP) has recommended approval of polatuzumab vedotin (Polivy) plus rituximab (MabThera) + cyclophosphamide, Doxorubicin (doubicin) and prednisone (R-CHP) are used in previously untreated diffuse large B-cell lymphoma (DLBCL).
Poltolimab + R-CHP is the first regimen in more than 20 years to significantly improve efficacy. With regard to the approval of polotolizumab combination therapy, a final decision by the European Commission is expected in the near future.
DLBCL is the most common type of non-Hodgkin lymphoma, and it is estimated that 40,000 people in Europe are diagnosed with the disease each year. About 4 out of ten patients relapsed after receiving first-line therapy, and most patients requiring follow-up had a poor prognosis.
Dr Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said: "A significant proportion of patients newly diagnosed with diffuse large B-cell lymphoma are not responding adequately to existing therapies. Therefore, we need more treatment options to increase patients' chances of cure, and we look forward to applying the combination therapy of polotolizumab to patients with DBL as soon as possible." ”
ChMP's recommendations are based on efficacy and safety data from the Phase III POLARIX study (GO39942), which compared the efficacy and safety of poltolizumab plus R-CHP chemotherapy regimens with standard therapy: rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) in first-line treatment of DLBCL. After a median follow-up time of 28.2 months, progression-free survival (PFS) in the trial group was significantly higher than in the R-CHOP group (HR 0.73; 95% CI:0.57–0.95; P
In terms of safety, the comparison of pololotuzumab plus R-CHP versus R-CHOP included: AEs with a rate of incidence of adverse events of grade 3 to 4 (57.7% vs 57.5%), severe AEs (34.0% vs 30.6%), grade 5 AEs (3.0% vs 2.3%) and AEs (9.2% vs 13.0%) resulting in dose reduction, with comparable safety profiles in both groups.
Bolotuzumab plus bendamustine + rituximab, once approved for marketing authorization in the EU, will be used to treat adult patients with relapsed or refractory DLBCL candidates for non-hematopoietic stem cell transplantation.
About polatuzumab vedotin (Polivy)
Poltolizumab is a best-in-class anti-CD79b antibody drug conjugate (ADC). The CD79b protein is specifically expressed in most B cells, an immune cell that affects certain types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polotolizumab binds to cancer cells such as CD79b and kills these B cells by delivering anticancer agents, while the drug is thought to minimize the effects on normal cells. Roche developed poltolizumab using Seagen ADC technology and is currently being studied for the treatment of several non-Hodgkin lymphomas. Polotolizumab is currently marketed in the European Union for the treatment of relapsed or refractory diffuse large B-cell lymphoma.
About Diffuse Large B-Cell Lymphoma (DLBCL)
DLBCL is the most common non-Hodgkin lymphoma (NHL) and accounts for about a third of NHL cases. DLBCL is an aggressive (rapidly growing) type of NHL, and although first-line therapy usually works, up to 40% of patients relapse or become refractory, with limited salvage options and short survival. It is estimated that about 150,000 people worldwide are diagnosed with DLBCL each year.