Kyprolis carfilzomib: Phase II data

Researchers at the Dana Farber Cancer Institute and colleagues reported data from an open-label, U.S. Phase II trial in 31 patients with Waldenstrom's macroglobulinemia who were naïve to treatment with a proteasome inhibitor and rituximab showing that IV Kyprolis plus rituximab and dexamethasone led to an ORR of 81%, including 1 complete response, 8 very good partial responses, 12 partial responses and 4 minor responses. Median time to response was 2.1 months. The researchers also said 30 patients concluded induction therapy with bone marrow tumor involvement reduced to a median of 7.5%. Treatment-related grade >2 toxicities included asymptomatic elevation in lipase, dexamethasone-related hyperglycemia, reversible neutropenia and cardiomyopathy. Patients received 20 mg/m 2 Kyprolis in cycle 1 then 36 mg/m 2 Kyprolis in subsequent cycles with 20 mg dexamethasone on days 1, 2, 8 and 9 and 375 mg/m 2 rituximab on days 2 and 9 of each 21-day cycle. Treatment consisted of 6 induction cycles followed by maintenance treatment beginning 8 weeks after completion of induction therapy. Patients also received concomitant treatment with acyclovir and famotidine. Data were presented at the American Society of Hematology meeting in New Orleans. ...