Today, Bristol-Myers Squibb Company (NYSE: BMY) announced results from a randomized Phase III study showing that patients receiving SPRYCEL 100 mg once a day achieved similar cytogenetic responses at six months with considerably fewer hematologic and non-hematologic adverse events than patients receiving three other dosing schedules of SPRYCEL.
The study evaluated four dosing schedules — including the U.S. Food and Drug Administration approved dose of 70 mg twice a day — and was conducted in patients with chronic-phase chronic myelogenous leukemia (CML) resistant or intolerant to Gleevec. Results were presented at the 48th Annual Meeting and Exposition of the American Society of Hematology (ASH).
“These data show that many patients who were resistant or intolerant to Gleevec responded to a once a day dose of SPRYCEL with an improved safety and tolerability profile compared to a twice a day schedule,” said Andreas Hochhaus, MD, Professor of Internal Medicine, University of Heidelberg, Mannheim, Germany.
The Phase III, open-label, randomized, multi-center international trial was conducted in 139 clinical trial sites. Patients were randomized to receive 50 mg twice a day (bid), 70 mg bid, 100 mg once a day (qd), or 140 mg qd. The primary objective of the study was to compare major cytogenetic response at six months among qd and bid regimens. Major cytogenetic response was defined as complete (no sign of Philadelphia chromosome-positive [Ph+] cells in the bone marrow) plus partial (less than 35 percent Ph+ cells in the bone marrow) cytogenetic responses.
The data presented show that comparable major cytogenetic responses were observed in all four treatment arms (50 mg bid = 54 percent; 70 mg bid = 56 percent; 100 mg qd = 59 percent; 140 mg qd = 57 percent). When compared to patients in the other three treatment arms; however, patients who received 100 mg once a day experienced:
Considerably lower incidence of grade 3 or 4 hematologic toxicities: thrombocytopenia, (p = 0.001); anemia, (p = 0.032); neutropenia, (p = 0.035); leukopenia, (p = 0.079).
Considerably lower incidence of pleural effusions (p =0.028).
All other non-hematologic events were comparable across all four treatment arms.