Methods: S55746/BCL201 monotherapy is currently being tested in an international, first-in-human, open-label, non-randomized, doseescalation study in patients (pts) ≥18 years with relapsed or refractory B-cell NHL including mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), small lymphocytic lymphoma (SLL), and diffuse large B-cell lymphoma (DLBCL). Primary objectives are to evaluate safety and establish the recommended phase 2 dose; secondary objectives include pharmacokinetics (PK), food interaction on PK, pharmacodynamics, and preliminary activity. S55746/BCL201 is administered once daily in fasting pts continuously over 21-day cycles until progressive disease (PD) or unacceptable toxicity. Pts could receive 50 to 2000 mg S55746/BCL201 according to a modified version of the continual reassessment method for dose allocation.Results: As of 9 March 2017, 37 NHL pts (median age 64 years, range 24-85) were dosed up to 1300 mg with a median duration on treatment of 42 days. NHL subtypes were DLBCL (68%), MCL (16%), FL (8%), and MZL (8%). Median number of prior regimens was 5 (range 2-15). Preliminary PK results showed that exposure increases linearly with some interindividual variability. Most common adverse events (AEs) include asthenia (n = 6), vomiting (n = 6) and nausea (n = 5).The most frequent (≥3 pts) grade ≥ 3 AEs were lymphopenia (n = 4), anemia (n = 3), and disease progression (n = 3). AEs possibly related to study drug were reported in 5 pts, the most frequent being nausea patients. Updated results up to 10 mg/kg will be presented at the meeting.

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