Bristol-Myers Squibb presented data from its Phase II CA180-226 clinical trial evaluating Sprycel (dasatinib) in treating pediatric patients with chronic myeloid leukemia at the 2017 American Society of Clinical Oncology annual Meeting in Chicago.
The ongoing trial evaluated the treatment in patients age 18 and younger. The patients were either newly diagnosed with chronic myeloid leukemia (CML) or had chronic phase CML (CP-CML) that were imatinib resistant or intolerant.
“Treatments for children and adolescents with newly diagnosed CML in chronic phase are limited, and even more so for those resistant to or intolerant of imatinib,” Dr. Lia Gore of the University of Colorado School of Medicine and Children’s Hospital of Colorado said in a release. “The time to and duration of responses along with the safety profile for patients studied suggest dasatinib could become an important option for pediatric patients with chronic phase CML.”
Newly diagnosed patients reached a cumulative complete cytogenetic response rate of 64 percent within six months of treatment, the release said. Those with imatinib resistant or intolerant CP-CML saw a cumulative major cytogenetic response of 55.2 percent within three months, which increased to 94 percent at 24 months.
“Chronic myeloid leukemia in pediatric patients is rare, making it difficult to study, and is often more aggressive in children and young adults,” Jonathan Leith, Bristol-Myers Squibb hematology development lead, said in the release. “As part of our commitment to advance new treatment options for pediatric cancer patients, this study was designed to evaluate the potential for Sprycel to address unmet needs for those with chronic phase CML, including a formulation developed specifically for children. The results demonstrate promising efficacy and safety in the first- and second-line settings.”
