The Phase 3 trial evaluated the efficacy, safety and pharmacokinetics of Polivy in combination with R-CHP, compared to R-CHOP
Roche Diagnostics administration and R&D buildings. (Credit: F. Hoffmann-La Roche Ltd.)
Roche announced that the Phase 3 POLARIX trial of its cancer drug Polivy (polatuzumab vedotin) has met the primary endpoint.
The Phase 3 trial evaluated the efficacy, safety and pharmacokinetics of Polivy plus MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP).
Polivy in combination with R-CHP was studied compared to R-CHOP (MabThera/Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone).
In the study, Polivy plus R-CHP significantly improved and clinically meaningful progression-free survival in people with previously untreated diffuse large B-cell lymphoma (DLBCL).
The treatment showed consistent safety outcomes with those observed in previous trials.
Roche global product development head and chief medical officer 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.”
Polivy is an anti-CD79b antibody-drug conjugate (ADC), developed using Seagen ADC technology and is currently being studied for the treatment of non-Hodgkin lymphoma (NHL).
The drug is currently being used as an off-the-shelf, fixed-duration treatment option in the relapsed or refractory (R/R) DLBCL setting.
It has been approved in combination with bendamustine and MabThera/Rituxan for the treatment of R/R DLBCL in more than 60 countries, including in the EU and in the US.
Roche is commercialising the drug in the US as Polivy (polatuzumab vedotin-piiq), through its subsidiary Genentech.
The Swiss drugmaker is investigating Polivy in combination with the CD20xCD3 T-cell engaging bispecific antibodies mosunetuzumab and glofitamab.
Polivy is being studied in combination with Venclexta/Venclyxto (venetoclax), which is being developed by AbbVie and Roche.
Also, the drug is being evaluated in combination with MabThera/Rituxan, gemcitabine and oxaliplatin in the Phase 3 POLARGO study.