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The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.
The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.
December 10, 2022
As of May 24, 2022, 21 pts enrolled and 17 pts received BMS-986393 at doses of 25 (n = 5), 75 (n = 9), and 150 (n = 3) × 106 CAR T cells. Among treated pts, 8 (47%) pts had high-risk cytogenetics (del[17p], t[4;14], and/or t[14;16]) and 8 (47%) pts had extramedullary plasmacytomas. Seven (41%) pts received prior BCMA-targeted therapies, including 6 (35%) pts treated with BCMA-directed CAR T cell therapy (Table). Four (24%) pts had penta-refractory MM.
Grade 3/4 treatment-emergent adverse events related to BMS-986393 (TRAEs) were reported in 11/17 (65%) pts; of these, the most frequent were neutropenia (41%) and thrombocytopenia (35%). TRAEs consistent with on-target, off-tumor activity affecting the skin (18%) and nails (12%), as well as dysgeusia/dysphagia (12%) were reported, all grade 1. Dose-limiting toxicities of prolonged (out to day 42) neutropenia and/or thrombocytopenia were reported in 2 pts; MTD has not been exceeded. Cytokine release syndrome (CRS) was reported in 11/17 (65%) pts, all grade 1/2 (median onset, day 3 [range, 2–4]; median duration, 2 days). Immune effector cell–associated neurotoxicity syndrome (ICANS)–type neurotoxicity was reported in 2/17 (12%) pts, both grade 1 (duration, 1–3 days), and was reversible with steroid treatment (Table).
Responses were reported in 12 of 14 pts evaluable for initial (1‑month) clinical response (overall response rate, 86%), including in 4/6 and 3/5 pts treated with prior BCMA‑directed and BCMA-directed CAR T cell therapies, respectively. Median duration of response has not been reached for any dose level, with median follow-up of 4.0 months (range, 1.0–13.1; Table).At the time of analysis, 15/17 (88%) pts remained in follow-up; 2 (12%) pts discontinued due to progressive disease.
In preliminary pharmacodynamic analyses, greater reductions in soluble BCMA levels were associated with increasing dose from 25 to 75 × 106 CAR T cells, and all 3 pts with complete response (CR) at the 25 × 106 CAR T-cell dose level were minimal residual disease (MRD)–negative (10−5 depth) at month 3, with follow-up ongoing.
Preliminary cellular pharmacokinetic analyses demonstrated a dose-dependent increase in BMS-986393 exposure
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