Supplemental BLA Accepted by FDA for Polatuzumab Vedotin/R-CHP Combo for Previously Untreated DLBCL

The FDA has accepted a supplemental biologics license application for polatuzumab vedotin-piiq (Polivy) plus rituximab (Rituxan), cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL), according to a press release from Roche.¹

The application is supported by results from the phase 3 POLARIX trial (NCT03274492) which assessed the regimen vs standard-of-care R-CHP and vincristine (R-CHOP).² The trial identified a clinically meaningful progression-free survival (PFS) improvement in the experimental arm as well as a 27% reduction in risk of progression, relapse, or death with a median follow-up of 28.2 months (HR, 0.73; 95% CI, 0.57-0.95; P <.02).

The FDA is expected to make a decision regarding the combination by April 2, 2023.

“The POLARIX study results suggest that Polivy plus R-CHP could transform the treatment of this aggressive malignancy, and we are working with the FDA to bring this combination to newly diagnosed DLBCL patients as soon as possible,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche, said in the press release. “We hope it will become the new standard of care for the first-line treatment of DLBCL, potentially reducing the need for subsequent treatments and limiting patient burden.”

The trial included a total of 879 patients who were randomly assigned 1:1 to either the polatuzumab vedotin plus R-CHP or R-CHOP arm. Patients were treated with either regimen for 6 cycles followed by rituximab for 2 cycles.

The study’s primary end point was PFS and secondary end points included complete response rate, event-free survival, overall survival, and disease-free survival.

The trial included a previously untreated population with CD20-positive disease. Patients needed to have an International Prognostic Index score of 2 to 5, an ECOG performance status of 0 to 2, and a life expectancy of 12 months or more.

Safety findings from the POLARIX study were similar to data from previous clinical trials. In the experimental and control groups, respectively, 57.7% vs 57.5% had grade 3/4 adverse effects (AEs), 34.0% vs 30.6% had serious AEs, 3.0% vs 2.3% had grade 5 AEs, and 9.2% vs 13.0% had AEs that led to a dose reduction.

The combination was approved by the European Union in May 2022 for patients with previously untreated DLBCL based on findings from the trial. Moreover, fixed-duration polatuzumab vedotin plus bendamustine/rituximab has been approved as a treatment for patients with relapsed/refractory DLBCL in both Europe and the United States.

References

1. FDA accepts supplemental biologics license application for Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma. News release. Roche. August 16, 2022. Accessed August 16, 2022. https://bit.ly/3C9QELH
2. Tilly H, Morschhauser F, Sehn LH, et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022;386(4):351-363. doi:10.1056/NEJMoa2115304