Regimen prolongs PFS in DLBCL
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An experimental first-line regimen significantly extended PFS compared with standard of care for patients with diffuse large B-cell lymphoma, topline results of a randomized phase 3 trial showed.
The R-CHP regimen — which consists of the anti-CD79b antibody-drug conjugate polatuzumab vedotin (Polivy, Genentech) plus rituximab (Rituxan; Genentech, Biogen), cyclophosphamide, doxorubicin and prednisone — is the first in 20 years to significantly improve outcomes for this patient population compared with the standard of care, according to a Genentech-issued press release.
Polatuzumab vedotin is approved in the United States for use in combination with bendamustine and rituximab for treatment of relapsed or refractory DLBCL.
The double-blind POLARIX trial included 879 patients with previously untreated DLBCL.
Researchers randomly assigned half of the patients to R-CHP for six cycles, followed by rituximab for two cycles. The other half of patients received standard R-CHOP — which consists of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone — for six cycles, followed by two cycles of rituximab.
The trial achieved its primary endpoint, demonstrating a statistically significant improvement in investigator-assessed PFS with R-CHP.
The regimen exhibited a safety profile consistent with those observed in prior trials.
“[Because] 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in the release. “This Polivy regimen is the first in 2 decades to improve progression-free survival in DLBCL compared [with] 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.”
Result of POLARIX will be submitted for presentation at a medical meeting.
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