By: Kerri Fitzgerald
Golcadomide, an investigational first-in-class oral CELMoD, is being assessed in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for patients with high-risk large B-cell lymphoma (LBCL). Grzegorz Nowakowski, MD, of the Mayo Clinic in Rochester, Minnesota, outlined details of the ongoing study as part of the 18th International Conference on Malignant Lymphoma in Lugano, Switzerland.
The double-blind, multicenter, randomized, phase 3 GOLSEEK-1 study is currently enrolling approximately 850 patients with untreated high-risk LBCL who will be randomized 1:1 to receive golcadomide 0.4 mg or placebo orally once daily for seven days plus R-CHOP in 21-day cycles for six cycles.
Eligible patients must have:
- Confirmed LBCL per the World Health Organization 2022 classification
- High-grade B-cell lymphoma (BCL) with MYC and BCL2 rearrangements
- T-cell/histiocyte-rich LBCL
- Epstein–Barr virus-positive diffuse LBCL (DLBCL)
Patients with another subtype of lymphoma or documented or suspected central nervous system involvement will be excluded.
The primary endpoint is progression-free survival, and secondary endpoints include event-free survival, undetectable measurable residual disease, and overall survival. Follow-up is expected to be approximately 67 months.
The study is currently enrolling at 309 sites in 36 countries.
A phase 1b study of golcadomide plus R-CHOP demonstrated its tolerability and showed “promising activity” with high rates of durable responses in patients with untreated aggressive BCL. Golcadomide also showed efficacy when combined with rituximab in relapsed or refractory DLBCL patients.
The study is supported by Bristol Myers Squibb.
Reference
Nowakowski GS, Hoffmann M, Munoz J, et al. GOLSEEK-1: a phase 3, double-blind, randomized study of golcadomide + R-CHOP versus placebo + R-CHOP in patients with previously untreated, high-risk large B-cell lymphoma. Abstract #OT04. Presented at the 18th International Conference on Malignant Lymphoma; June 17-21, 2025; Lugano, Switzerland.
