Abstract: Results: As of 20 March 2023, 28 patients received MeziVd, 38 MeziVd-1.0 mg, and 27 MeziKd. Across all cohorts, 65.8-88.9% patients were IMiD agent-refractory, 18.4-51.9% proteasome inhibitor (PI)-refractory, and 36.8-74.1% anti CD38 monoclonal antibody (mAb)-refractory; median follow-up was 10.8-13.2 months. The most frequent grade 3-4 treatmentemergent adverse events (TEAEs) were neutropenia (35.7%) and thrombocytopenia (21.4%) with MeziVd; neutropenia (57.9%) and all infections (34.2%) with MeziVd-1.0 mg; and neutropenia (40.7%) and all infections (29.6%) with MeziKd. Excluding all infections, grade 3-4 non-hematologic TEAEs were low. Overall response rate was 75.0% (MeziVd), 84.2% (MeziVd-1.0 mg), and 85.2% (MeziKd). In the MeziVd-1.0 mg cohort, 2 patients were minimal residual disease-negative (10-4 threshold). Median time to response was 1.38 (0.7-3.3), 0.89 (0.7-2.4), and 0.95 (0.9-5.1) months in the MeziVd, MeziVd-1.0 mg, and MeziKd cohorts, respectively. Median duration of response was 10.4 and 11.9 months in the MeziVd and MeziKd cohorts, respectively, and not reached in the MeziVd-1.0 mg cohort. MEZI showed pharmacodynamic activity with BORT/CFZ at all doses; 1.0 mg induced the greatest substrate degradation and T-cell proliferation.
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