STAR-LLD

Six relapsed/refractory MM patients were enrolled from two U.S. community-based investigational sites in the Phase 1b study. Median age was 73, male to female ratio 1/1, Caucasian 100%, and median lines of previous therapy were 2 (range 1-7). Two patients were refractory and four were relapsed to their prior treatment. Four patients were previously exposed to lenalidomide, one of which was discontinued from a prior regimen because of severe fatigue, and all six had received prior bortezomib. Patients received 3-12 cycles of study therapy.

• No patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy.
• Non-hematologic toxicities did not exceed Grade 2
• The PK/PD data minimized Cmax and lowered AUC while achieving biologically active doses and reducing toxicity
  • STAR-LLD pharmacokinetics produced median steady-state blood levels (Cmax) of 39 ng/mL (N=6) and were above the minimum target of 25 ng/mL.
• All six patients receiving STAR-LLD achieved an objective response (1 CR and 5 PRs); one patient who achieved a partial response experienced a Grade 2 skin reaction during cycle 3 and withdrew from the study
• Continuous treatment with STAR-LLD does not appear to significantly increase immune checkpoints associated with T cell exhaustion
• Five patients are continuing treatment per protocol with a median PFS of > 10 months