Gleevec sets new leukemia treatment standard, Novartis claims

Results of the study, named IRIS, were presented at the 2006 annual meeting of the American Society of Clinical Oncology (ASCO). Data from the study, the largest clinical trial to date for newly diagnosed adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, showed the overall survival rate at five years to be 89.4% for patients receiving Gleevec (imatinib mesylate).

This considers deaths from all causes, but only 4.6% of the patients died from causes related to their leukemia. Before Gleevec was available, about 50% of patients progressed to the more advanced stages of Ph+ CML after only three to five years, and survival was generally short for those patients.

The results of this phase III trial, which was started in June 2000, also showed that the number of patients with a complete cytogenetic response increased from 69% to 87% between the first and fifth years of treatment. Moreover, the yearly risk of progressing to advanced disease continued to decline – to 0.6% in the fifth year.

“Very few oncology medicines offer patients the opportunity to achieve better outcomes the longer they take the therapy,” said David Epstein, president of Novartis Oncology. “That Gleevec demonstrates these significant improvements with long-term use is a good sign science will provide the path to turn lethal cancers into potentially manageable conditions with durable, well-tolerated targeted therapies.”

An estimated 93% of Gleevec patients in the early, chronic phase of CML did not progress to the rapidly lethal advanced stages of the disease, and an estimated 83% survived with no evidence of disease progression at all at the five-year follow-up.