Today, Bristol-Myers Squibb Company (NYSE: BMY) announced results of a randomized Phase II study showing that a substantial number of patients with chronic-phase chronic myelogenous leukemia (CML) resistant to Gleevec achieved cytogenetic and hematologic responses by three months and maintained these responses through one year when treated with SPRYCEL.
The open-label, multi-center international trial was designed to examine the efficacy and safety of SPRYCEL at 70 mg twice daily or an increased dose of Gleevec to 800 mg/day (patients enrolled in the trial had been previously treated with Gleevec less than or equal to 600 mg/day). Results were presented at the 48th Annual Meeting and Exposition of the American Society of Hematology (ASH).
Analysis of the data at three months and 15 months show that the number of patients who achieved and maintained a major cytogenetic response increased from 36 percent to 53 percent with SPRYCEL, and from 29 percent to 33 percent with escalated doses of Gleevec.
While the study was not powered to compare SPRYCEL to high-dose Gleevec, analysis of the data after a median follow-up of 15 months show a statistically significant difference between SPRYCEL and high-dose Gleevec in progression-free survival (length of time during which the leukemia does not progress) (p<0.0001), major and complete cytogenetic responses (p=0.023 and p=0.004, respectively) and major molecular response (p=0.038). “This study may help answer important questions about treating resistant chronic-phase CML patients and suggests that physicians should consider treatment with SPRYCEL in patients resistant to lower doses of Gleevec,” said Neil Shah, MD, PhD, Assistant Professor, Division of Hematology/Oncology, University of California, San Francisco.