ARRY-520: Interim Phase Ib data

Interim data from 6 patients with relapsed or refractory MM who are refractory or intolerant to bortezomib in an investigator-sponsored, open-label, dose-escalation, U.S. Phase Ib trial showed no dose-limiting toxicities (DLTs) in the first cohort of patients receiving 0.75 mg/m 2 IV ARRY-520 plus 20/27 mg/m 2 carfilzomib. ARRY-520 was administered on days 1, 2, 15 and 16 of a 28-day cycle, while carfilzomib was administered on days 1, 2, 8, 9, 15 and 16. Patients received 20 mg/m 2 carfilzomib on days 1 and 2 and 27 mg/m 2 for all subsequent doses. There was a DLT of influenza pneumonia with non-neutropenic fever in the second cohort of patients receiving 1 mg/m 2 ARRY-520 plus 20/27 mg/m 2 carfilzomib. In the first cohort (n=3), there was 1 case of near complete remission, 1 case of stable disease and 1 case of disease progression. In the second cohort, all 3 patients who completed the first cycle of treatment had stable disease and remain on trial. Grade 3 adverse events include pneumonia, diarrhea and hyperglycemia. The MTD has not yet been reached and enrollment in the second cohort is ongoing. Data will be presented at the American Society of Hematology meeting in Atlanta in December. ...