Oncology Drug Research, Development, and Manufacturing
On August 9, 2021, Roche announced that Polivy (polatuzumab vedotin), its "first-in-class" CD79b-targeting antibody-drug conjugate (ADC), in combination with the R-CHP chemotherapy regimen, met the primary endpoint in the pivotal Phase 3 POLARIX clinical trial for the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL). Compared with the standard-of-care R-CHOP regimen, a clinically meaningful and significant improvement in progression-free survival (PFS) was observed in patients.
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL), accounting for approximately one-third of NHL cases. As an aggressive form of NHL, approximately 150,000 new cases are diagnosed globally each year. Although first-line therapy is generally effective, up to 40% of patients experience relapse or develop refractory disease. At this stage, treatment options are limited and survival is short, representing a significant unmet medical need.
The CD79b protein is specifically expressed in most B cells, making it a promising target for the development of novel therapies. By specifically binding to CD79b on tumor cells, Polivy delivers anticancer agents to kill these B cells while minimizing damage to normal cells. Currently, Polivy has been approved in over 60 countries and regions worldwide, in combination with bendamustine or rituximab, for the treatment of patients with relapsed or refractory (R/R) DLBCL.
The POLARIX clinical trial evaluated the efficacy, safety, and pharmacokinetics of the Polivy + rituximab + cyclophosphamide + doxorubicin + prednisone (R-CHP) chemotherapy regimen compared with the standard rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone (R-CHOP) therapy in patients with previously untreated DLBCL.
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References:
[1] Ad hoc announcement pursuant to Art. 53 LR] Phase III study shows Roche's Polivy plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive form of lymphoma compared to standard of care. Retrieved August 9, 2021, from https://www.roche.com/media/releases/med-cor-2021-08-09.htm
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