Bristol Myers announces results from two early golcadomide combination studies

Bristol Myers announced the results of two early studies evaluating combinations of CELMoD agent golcadomide in non-Hodgkin lymphomas. These data are being presented in separate posters at the 2023 American Society of Hematology, or ASH, Annual Meeting from December 9-12. In the dose expansion phase of this Phase 1b study, patients were randomized 1:1 to golcadomide at one of two recommended Phase 2 dose levels plus R-CHOP-21 for a fixed duration of six cycles. A total of 65 patients completed six cycles of the combination with 13 discontinuing treatment. There were 71 patients evaluable for efficacy, and results showed: Overall response rate, or ORR, at end of treatment rate was 84.5% in patients overall, with 87.9% of patients in the DL1 arm achieving a complete metabolic response, or CMR, compared to 63.6% in the DL-1 arm. Minimal residual disease negativity at the end of treatment was achieved in 93% of patients treated with 0.4 mg of golcadomide plus R-CHOP compared to 70% treated with 0.2 mg of golcadomide plus R-CHOP. At both DL1 and DL-1, steady-state levels of golcadomide reduced Ikaros over 80%, to levels predicted to optimize tumor cell killing and to stimulate T and NK cells. In the safety population, the majority of patients experienced at least one treatment-emergent adverse event. Grade 3/4 TEAEs were primarily hematologic with neutropenia, thrombocytopenia and anemia being the most common. Any grade febrile neutropenia was reported in 21.8% of patients. Median relative dose intensity of key R-CHOP components was maintained at greater than 90%. A separate poster detailed the efficacy and safety results from the dose expansion segment of a Phase 1/2 open-label study of two doses of golcadomide plus rituximab in relapsed/refractory patients with non-Hodgkin lymphoma. Patients were heavily pre-treated with a median number of four prior therapies, including 61% who had prior CAR T. In patients evaluable for efficacy, the ORR was 42% with 19% achieving a complete response, or CR. The median duration of response was 7.5 months. The ORR and CR rate was greater for patients in the 0.4 mg arm compared to the 0.2 arm. In the study, neutropenia was the most common TEAE of any grade, occurring in 50% of patients. Febrile neutropenia was observed in two patients, with one patient at each dose level. A total of six patients had serious adverse events with only pneumonia and pyrexia occurring in more than 1 patient. There were four deaths on treatment during the study with one considered related to the study treatment.