2022-11-27| Trials & Approvals

Canada Authorizes Roche’s Polivy as First-Line Lymphoma Treatment

by Reed Slater
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After success in the clinic and on the market as a second-line treatment, Health Canada authorized Roche’s CD79b-targeting antibody-drug conjugate, Polivy, as a first-line treatment for patients with untreated large B-cell lymphoma (LBCL), including diffuse LBCL (DLBCL). Genentech, a Roche subsidiary, is eyeing the same approval in the American market after the FDA accepted its supplemental biologics license application (BLA) in August this year. 

A New First-Line Treatment for Lymphoma Patients

LBCL is the most common type of lymphoma, a blood cancer that develops in the lymphatic system, which works with other parts of the immune system to help fight off infections and disease. As many as 40% of LBCL patients experience relapse within 24 months of initial treatment, so Roche says that an additional first-line treatment option may reduce the need for later-line treatments. 

Roche designed Polivy to target CD79b, a cell surface component of B-cell receptors. Once it binds to the cell surface, CD79b rapidly internalizes, helping deliver monomethyl auristatin E (MMAE), which works to kill dividing cells. 

Health Canada authorized Polivy based on the POLARIX Phase 3 clinical trial, which compared Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone to standard-of-care (R-CHOP) treatments. The trial included 879 participants with untreated LBCL; the primary endpoint was investigator-assessed progression-free survival. Participants who received Polivy experienced a 27% reduction in relapse or death compared to R-CHOP.

Dr. Laurie Sehn, Chair of the Lymphoma Tumor Group at the BC Cancer Centre for Lymphoid Cancer and Clinical Professor of Medicine in the Division of Medical Oncology at the University of British Columbia, spoke about the challenges of the initial management of LBCL. She said, “The POLARIX trial demonstrates a meaningful improvement in progression-free survival with the addition of polatuzumab vedotin and represents important progress in frontline therapy.”

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The Quest to Carry Momentum into the American Market

The Canadian authorization came just a few months after the FDA accepted Genentech’s supplemental BLA for Polivy as a first-line treatment. If all goes well for the Roche subsidiary, the FDA could administer a decision by April 2, 2023.

Genentech will use the same POLARIX Phase 3 trial as the basis for the supplemental BLA, which Canadian authorities found sufficient for the same indication. Roche and Genentech say that the POLARIX trial is the first in two decades to show a clinically meaningful improvement in progression-free survival in LBCL patients. 

The FDA granted Polivy accelerated approval as a second-line LBCL treatment in June 2019. Accelerated approval requires confirmatory trials for full approval and additional indications, which Genentech and Roche have been working hard at to prove the drug’s worth in the lymphoma treatment market. 

Health Canada’s Polivy authorization is a sign of good things to come for the drug, which Roche and Genentech hope will become a new standard-of-care treatment for LBCL. Hopefully, by April of next year, the FDA will render its decision on whether or not it thinks Polivy is an acceptable first-line lymphoma treatment for the American market. 

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