The data were presented by Dr Jef Jones from the MD Anderson Cancer, at the tenth annual international congress on hematologic malignancies in Whistler, British Columbia.
In this trial, 241 patients were treated with fludarabine plus cyclophosphamide (Flu/Cy) with or without Genasense. The primary endpoint of the study was to increase the proportion of patients who achieved a complete or nodular partial remission (CR/nPR).
In the trial the addition of Genasense increased the proportion of patients who achieved complete or nodular partial remission from 7% in the Flu/Cy-only arm to 17% in the Genasense arm. Additionally, the duration of the remission achieved was significantly longer in patients treated with Genasense compared with patients who received Flu/Cy only.
For both treatment groups, patients who achieved CR/nPR had a median of approximately 11 months longer duration of symptom relief compared with patients whose best response was partial remission.
“The analysis from this large, prospective, randomized trial reconfirms what has been intuitively understood by oncologists and hematologists, namely that the achievement of complete remission is highly beneficial for patients with leukemia,” said Dr Loretta Itri, Genta’s chief medical officer. “We look forward to improving on these results when we extend the use of Genasense into studies of patients with less advanced disease.”