Genentech presents updated data from the Phase 3 POLARIX study

Genentech, a member of the Roche, announced that new and updated data for its first-in-class anti-CD79b antibody-drug conjugate Polivy were presented at the 64th American Society of Hematology Annual Meeting & Exposition, December 10-13. Data from the POLARIX study support the potential benefit of Polivy in combination with Rituxan, cyclophosphamide, doxorubicin and prednisone to improve outcomes for people with previously untreated diffuse large B-cell lymphoma. After a median follow up of three years, progression-free survival data continued to show a statistically significant reduction in the risk of disease worsening or death with Polivy plus R-CHP compared with Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone. After a median follow-up of 39.7 months, overall survival data was immature with few events in each arm and remained similar between Polivy plus R-CHP and R-CHOP. In the longer follow-up analysis, no new safety signals were identified. Health-related quality of life data from the POLARIX study were also presented, showing that most patients with previously untreated DLBCL receiving Polivy plus R-CHP or R-CHOP reported clinically meaningful improvements in lymphoma symptoms after the first cycle of treatment across both arms. Improvements in fatigue and physical functioning were similar with Polivy plus R-CHP versus R-CHOP, with 74.8% versus 68.2% of patients reporting improvements in fatigue and 42.4% versus 39.6% of patients reporting clinically meaningful improvements in physical functioning at any time point. Reported improvements were sustained during and after first-line therapy, up to the 24-month follow-up. This HRQoL analysis of the POLARIX study demonstrates that these patient-reported outcomes are not compromised with improved PFS, highlighting the potential of Polivy to help manage the burden of DLBCL. The need for more effective treatments for patients with previously untreated DLBCL was underscored in an economic analysis of the total cost of care in relapsed or refractory DLBCL. The study evaluated healthcare costs and resources in the second-line setting and beyond, and found that total healthcare costs increased with each additional line of treatment. Separately, an analysis of the POLARIX study also presented at ASH showed that over the next ten years, Polivy plus R-CHP has the potential to reduce the number of patients receiving second-line treatment by 27% compared to R-CHOP, potentially improving the chance of a positive outcome for more patients and significantly reducing the overall treatment burden of DLBCL. Based on the pivotal data from the POLARIX study, more than 50 countries have approved Polivy in combination with R-CHP for the treatment of adult patients with previously untreated DLBCL, including the EU, Japan and, most recently, Canada. The company’s supplemental Biologics License Application was accepted by the U.S. Food and Drug Administration, and a decision is expected by April 2, 2023. Polivy is currently approved in more than 80 countries and regions worldwide, including in the U.S. and Europe, as a readily available, fixed-duration treatment option for R/R DLBCL in combination with bendamustine and Rituxan, after at least two prior therapies. Genentech continues to explore areas of unmet need where Polivy has the potential to deliver additional benefit, including in ongoing studies investigating combinations of Polivy with CD20xCD3 T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, including the Phase III SUNMO study in combination with mosunetuzumab, and with Rituxan in combination with gemcitabine and oxaliplatin in the Phase III POLARGO study.