A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants with Previously Untreated High-risk large B-cell Lymphoma (GOLSEEK-1)

This randomized, Phase 3 study has been designed as an add-on placebo-controlled study where golcadomide has been added to the established standard of care (SOC), which is R-CHOP in the experimental arm while placebo in combination with R-CHOP will comprise the control arm. For almost 2 decades, R-CHOP chemotherapy has remained the standard of care for untreated LBCL patients. The chemotherapy regimen and dosing for CHOP was established in the 1970s, and the addition of the anti-CD20 monoclonal antibody rituximab (R) was approved in 2006 based on 3 large, randomized studies, which consistently demonstrated a survival benefit in favor of the R-CHOP combination. Since then, multiple clinical trials have sought to improve upon R-CHOP in the 1L setting. Unfortunately, all failed to demonstrate improved outcomes compared to R-CHOP alone. Recently, however polatuzumab in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (pola-R-CHP) was approved in the US and EU for the treatment of adult patients with untreated DLBCL, NOS or HGBL, and an IPI score of 2 or greater based on the results from the Phase 3 POLARIX study. Additionally, based on these results, pola-R-CHP was recently made a category 1 recommendation alongside R-CHOP for the first-line treatment of patients with LBCL in the National Comprehensive Cancer Network (NCCN) guidelines.