Roche has reported that Polivy (polatuzumab vedotin) plus chemotherapy regimen met the primary goal of Phase III POLARIX clinical trial for treatment naïve diffuse large B-cell lymphoma (DLBCL).
The chemotherapy regimen included MabThera/Rituxan (rituximab) along with cyclophosphamide, doxorubicin and prednisone (R-CHP).
Polivy is an anti-CD79b antibody-drug conjugate (ADC) being developed by Roche using the ADC technology of Seagen.
The ADC attaches to cancer cells such as CD79b and destroys these B-cells by delivering an anti-cancer agent, which is believed to reduce the effects on normal cells.
The global, randomised, double-blind, placebo-controlled Phase III POLARIX trial analysed the efficacy, safety and pharmacokinetics of Polivy plus R-CHP compared with standard of care (SoC) treatment in 879 DLBCL patients.
The SoC regimen included MabThera/Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP).
Trial data showed that Polivy plus R-CHP offered substantial improvement and clinically meaningful progression-free survival (PFS), meeting the primary goal.
Furthermore, the safety profile of the drug was in line with that observed in earlier trials.
Polivy plus R-CHP is the first treatment in two decades to boost outcomes in a previously untreated aggressive form of lymphoma, Roche noted.
Roche chief medical officer and Global Product Development head Levi Garraway said: “Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative.
“This Polivy regimen is the first in two decades to improve progression-free survival in DLBCL compared to the standard of care, and we look forward to sharing these results with health authorities to bring this important potential new treatment option to patients as soon as possible.”
The company added that the data from the POLARIX trial will be submitted to health authorities across the world soon.
Polivy is currently approved for use, along with bendamustine and MabThera/Rituxan, for relapsed or refractory DLBCL treatment in more than 60 countries, including the US and EU.
Last month, Roche reported that Evrysdi (risdiplam) met the primary goal of the FIREFISH Part 2 study in infants aged one to seven months with symptomatic Type 1 spinal muscular atrophy (SMA).