Genentech, a member of the Roche Group, today announced five-year follow-up data from the pivotal Phase III POLARIX study. The study evaluated Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP) in patients with untreated diffuse large B-cell lymphoma (DLBCL). The results were presented in an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 7-10, 2024, in San Diego, California. This analysis, conducted after a median follow-up of 60.9 months, includes detailed data on both primary and secondary endpoints, as well as safety findings.
Genentech has announced promising five-year follow-up data from its pivotal Phase III POLARIX study, which evaluated the combination of Polivy® (polatuzumab vedotin-piiq) with Rituxan® (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL). The study results, presented at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego, highlight the potential of Polivy to improve outcomes for patients with this aggressive cancer.
“POLARIX was the first trial in two decades to set a new standard of care for frontline DLBCL, and the five-year data further support the potential of Polivy in improving patient outcomes,” said Dr. Levi Garraway, Chief Medical Officer at Genentech. Over 38,000 patients worldwide have been treated with Polivy in combination with R-CHP, emphasizing its potential to become a cornerstone in treating aggressive lymphoma.
The five-year follow-up analysis revealed a positive trend in overall survival (OS) for patients treated with Polivy in combination with R-CHP. In the intent-to-treat (ITT) population, Polivy showed a 15% reduction in the risk of death (HR 0.85; 95% CI: 0.63–1.15) compared to R-CHOP (Rituxan, cyclophosphamide, doxorubicin, vincristine, and prednisone). This trend marks an improvement over the three-year data, which showed a smaller reduction in risk (HR 0.94; 95% CI: 0.67–1.33). The full difference in OS between the two treatment arms has not yet been fully realized, and the follow-up continues, suggesting further benefit over time.
The study also highlighted a notable reduction in the need for additional treatments. Patients receiving Polivy in combination with R-CHP required nearly 25% fewer follow-up interventions like radiation, chemotherapy, and CAR-T cell therapy compared to those treated with R-CHOP (38.3% versus 61.7%).
At the five-year mark, progression-free survival (PFS) and disease-free survival (DFS) benefits were sustained, reinforcing the durability of the Polivy combination in inducing lasting remissions. There was also a numerical reduction in lymphoma-related deaths, with 9.0% of patients on the Polivy combination versus 11.4% in the R-CHOP group.
The safety profile of Polivy in combination with R-CHP remained consistent with prior data, with no new safety concerns identified. The treatment was generally well tolerated, confirming the positive benefit-risk balance for this combination.
With approval in over 90 countries, including the U.S., the EU, Japan, Canada, and China, Polivy in combination with R-CHP is already available as a first-line treatment for DLBCL. Genentech continues to expand access globally and is exploring other combinations, such as with bispecific antibodies, to further enhance treatment options.
The POLARIX study was conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC), and continues to be an important milestone in advancing DLBCL treatment.
