Strong Ph III data for Bioenvision's Evoltra

New York, USA-based Bioenvision says that the latest results from an ongoing European study of Evoltra (clofarabine) in pediatric acute lymphoblastic leukemia (BIOV-111) supports its recent European approval (Marketletter June 12), showing that the purine nucleoside analog delivers a significant response rate in this difficult-to-treat patient population.

In addition, the firm says that updated results from the pivotal CLO-2122 clinical study showed that response to clofarabine provides the opportunity for patients to proceed to stem cell transplant, which offers them the best chance for long-term survival. The data were presented at the 38th Congress of the International Society of Pediatric Oncology, held in Geneva, Switzerland.

Although the first-line treatment of children with leukemia is generally successful, patients with multiple relapsed or refractory forms of the condition have a low response rate to existing treatment options and a very poor prognosis, with a median survival of approximately nine-10 weeks.