The phase 1b CC-220-DLBCL-001 trial (NCT04884035) investigated the safety and efficacy of golcadomide plus R-CHOP in participants with untreated aggressive BCL. Participants received ≤6 21-day cycles of golcadomide plus R-CHOP therapy and were randomised to 0.2 mg or 0.4 mg golcadomide at days 1 to 7 of each treatment cycle during the dose expansion phase. Of the 78 included participants, 82% had high-risk disease, and 82% had diffuse large BCL with not otherwise specified histology. Safety was the primary endpoint of this study and Dr Marc Hoffman (The University of Kansas Cancer Center, KS, USA) presented the 12-month follow-up results1.
Grade 3 or 4 treatment-emergent adverse events (TEAEs) were seen in 91% of the participants, predominantly neutropenia (87%) and thrombocytopenia (42%). Serious TEAEs were reported in 46% of the participants, of which febrile neutropenia (19%) was the most common AE.
In the highest dose group (n=29), the CMR rate was 88% at the end of therapy and all participants were progression-free. This result was consistent across risk and cell of origin subgroups. At 12 months follow-up, the progression-free survival rate was 85% in the high-dose group and 75% in the low-dose group, with similar rates in high-risk participants.
These findings support the GOLSEEK-1 trial (NCT06356129), an upstarting phase 3 study comparing golcadomide plus R-CHOP to R-CHOP alone as first-line treatment for participants with high-risk diffuse large BCL.
Medical writing support was provided by Robert van den Heuvel.