Five-year results confirm Roche’s Polivy combination therapy as new standard of care for previously untreated aggressive lymphoma

Roche announced  data from a 5-year follow-up of the pivotal phase III POLARIX study.

Data were presented in an oral session at the 66^th American Society of Hematology (ASH) Annual Meeting and Exposition, 7-10 December in San Diego, US. This latest analysis conducted after a median follow-up of 60.9 months, includes descriptive data on primary and secondary endpoints, as well as safety results. Follow-up exploratory analysis after five-years indicated a positive trend in overall survival (OS) in the intent-to-treat (ITT) population in favour of Polivy in combination with R-CHP compared to Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP). Results showed a trend in reduction in the risk of death (HR 0.85; 95% CI: 0.63–1.15) for people with previously untreated DLBCL with the Polivy combination, an improvement on the three-year follow-up data (HR 0.94; 95% CI: 0.67–1.33). The 5-year analysis of POLARIX indicates that the full difference in OS between treatment arms has yet to be observed and an additional two years of follow-up will continue.

In addition to the positive trend in OS, an observational analysis suggested nearly 25% fewer follow-up treatments such as radiation, systemic chemotherapy and CAR-T cell therapy were needed in patients receiving Polivy in combination with R-CHP compared to those treated with R-CHOP (38.3% vs 61.7%).¹ Based on findings from a previous economic analysis which found that total healthcare costs increased with each additional line of treatment in relapsed or refractory DLBCL, a reduction in the number of subsequent therapies could potentially alleviate some of the burdens associated with relapse and disease progression.

At five years of follow-up, benefits in progression-free survival and disease-free survival with Polivy in combination with R-CHP were maintained, consistent with the three-year follow-up data, reinforcing the potential of Polivy in combination with R-CHP to provide durable and lasting remissions. The latest follow-up data also showed a numerical reduction in death related to patients’ lymphoma in those treated with Polivy in combination with R-CHP compared to those treated with R-CHOP (9.0% vs 11.4%). The safety profile remains consistent with the known profiles of the individual study medicines with no new safety signals observed, reinforcing the positive benefit-risk profile of this Polivy combination. Results from an expanded cohort of 1,000 patients including global and Chinese patients demonstrated comparability to the global ITT population.

“POLARIX was the first trial to elevate treatment standards for frontline diffuse large B-cell lymphoma in 20 years and we are additionally encouraged by the five-year follow-up results,” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “More than 38,000 people worldwide have been treated with Polivy in combination with R-CHP and these data continue to underscore its potential to improve outcomes for people diagnosed with this aggressive lymphoma.”

“Diffuse large B-cell lymphoma is a notoriously challenging cancer to treat, however, Polivy in combination with R-CHP has shown to be a critical advance for patients by helping to reduce relapse and disease progression,” said Dr. Gilles Salles, Chief of Lymphoma Service, Division of Hematological Malignancies, Memorial Sloan Kettering Cancer Center, US. “The survival trend seen in this follow-up analysis reinforces the potential impact of frontline treatment with Polivy in combination with R-CHP and its role as a standard of care therapy.”