June 22, 2009
Updated Phase 3 follow-up data of pixantrone for the treatment of Non-Hodgkin's LymphomaCell Therapeutics announced that updated data from their Phase 3 PIX 301 EXTEND trial enhances previously reported response rates for pixantrone over comparator, including in high risk patient subgroups, for the treatment indolent Non-Hodgkin's Lymphoma (NHL).
PIX 301 EXTEND was a single-agent trial of pixantrone of 140 patients with relapsed or refractory, aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. Patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician. The trial achieved its primary endpoint with patients randomized to pixantrone achieving a significantly higher rate of confirmed (CR) and unconfirmed complete remissions (CRu) compared to patients treated with standard chemotherapy (20% [14 of 70 patients] versus 5.7% [4 of 70 patients], respectively, p=0.02), with no patients in the standard chemotherapy arm achieving a confirmed complete remission while on study.
Initial follow-up data in the PIX 301 EXTEND trial demonstrated that three additional patients in the pixantrone arm achieved a CR and one additional patient achieved a CRu during the follow-up period of patients that received chemotherapy on the control arm. Including the treatment and follow-up period, pixantrone had a significantly higher complete remission rate compared to the patients who received standard chemotherapy (CR/CRu rate=24% [17 of 70 patients] for pixantrone versus CR/CRu rate=7% [5 of 70 patients] for standard chemotherapy; p=0.009). No patient in the standard chemotherapy arm achieved a confirmed complete remission at this point. The overall response rate was also significantly higher for pixantrone treated patients and was 40% (28 of 70 patients) for pixantrone versus 14.3% (10 of 70 patients) for standard chemotherapy with p=0.001. In subgroup analyses, higher response rates in the pixantrone treatment group compared to comparator group were observed consistently across all of the following subgroups: age (<65 or ≥65 years old); whether the patient was refractory to last therapy; or whether the international prognostic index (IPI) score, a predictor of risk of disease recurrence and overall survival, was ≥2. The follow-up period of this study is ongoing.
Pixantrone is a novel major groove binder with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents.
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