An investigational leukaemia drug has been found to increase survival by three times.
The drug, elacytarabine (CP-4055), developed by Norway-based Clavis Pharma, has completed a Phase II trial in patients with late-stage acute myeloid leukaemia, which showed “statistically significant superior efficacy” compared to published clinical data on late-stage AML.
The study looked at patients who had failed two previous therapeutic regimens. Currently, there is no standard therapy available for such patients.
The response to the treatment was compared with a detailed historical outcome analysis of 594 similar third-line therapy AML patients, who were treated at the MD Anderson Cancer Centre.
The key results found median survival was three times longer at 5.5 months compared with the published 1.5 months, while the remission rate was significantly increased at 15% compared with the 2.5% expected remission rate for similar groups of patients.
“Remarkably, elacytarabine has shown prolonged survival, a significant reduction in early mortality and a substantially and unexpectedly higher complete remission rate for these patients compared to previously published experience,” said Professor Francis Giles, Coordinating Investigator for the trial.
“Since elacytarabine also is well tolerated by both younger and elderly patients, it has the potential to become the standard therapy for refractory/relapsed AML,” Giles added.
Follow-up on survival data is ongoing and the company is now in the process of designing a pivotal registration study.
