Roche has shared new and updated data for Polivy (polatuzumab vedotin) from its phase 3 POLARIX study, supporting its potential benefits when used in combination with MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
The most common form of non-Hodgkin lymphoma (NHL), DLBCL accounts for about one in three cases of NHL.
The positive results for Roche’s first-in-class anti-CD79b antibody-drug conjugate continue to show a statistically significant reduction in the risk of disease worsening or death for people with previously untreated DLBCL and were presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition.
In addition to this, those given Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes, during and after fixed-duration treatment, compared to patients receiving the current standard of care, with superior progression-free survival (PFS), which was noted as being the primary outcome measure. This was evaluated by the investigator using the Lugano Response Criteria for malignant lymphoma.
After a median follow-up of three years, progression-free survival (PFS) data continued to show a statistically significant reduction in the risk of disease worsening or death with Polivy plus R-CHP compared with rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP.
Moreover, after a median follow-up of 39.7 months, overall survival (OS) data was immature with few events in each arm and remained similar between Polivy plus R-CHP and R-CHOP. No new safety signals were identified in the longer follow-up analysis.
“Too many patients with diffuse large B-cell lymphoma see their cancer relapse or progress after initial treatment. This highlights the need to improve on a standard of care that has remained unchanged for the last two decades,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
Data regarding health-related quality of life from the POLARIX study was also presented at ASH, demonstrating that most patients with previously untreated DLBCL who were given Polivy plus R-CHP or R-CHOP experienced clinically meaningful improvements in lymphoma symptoms after the first cycle of treatment across both arms (82.3% and 81.3% of patients, respectively).
The EU, Japan and most recently Canada have been among those countries which have approved Polivy in combination with R-CHP for the treatment of adult patients with previously untreated DLBCL, based on the pivtotal POLARIX data.
The US Food and Drug Administration has accepted Roche’s supplemental Biologics License Application for the treatment and its decision is expected by 2 April 2023.