Addition of Pixantrone to Rituxan(R) Therapy Significantly Prolongs Time to Disease Progression and Improves the Overall Response Rate Compared to Rituxan Alone in Relapsed or Refractory Indolent Lymphoma
Wednesday November 9, 8:30 am ET
Randomized Controlled Trial Meets Primary and Secondary Endpoints
NEW YORK, Nov. 9 /PRNewswire-FirstCall/ -- At a presentation at the CIBC World Markets 16th Annual Healthcare Conference, Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) presented results from a randomized controlled study of Rituxan versus Rituxan plus pixantrone in 38 relapsed or refractory patients who had previously failed up to five prior treatments for indolent non-Hodgkin's lymphoma (NHL). The study achieved its primary objective of prolonging the time before a patient's lymphoma progressed (time to disease progression, or TTP). Patients receiving the combination of Rituxan and pixantrone had an 87 percent overall improvement in TTP compared to Rituxan alone. The median TTP estimate for the pixantrone/Rituxan recipients was 13.2 months compared to 8.1 months for Rituxan alone (hazard ratio 0.13, log rank p <0.001). The one- and two-year progression-free survival estimates were 66 percent and 44 percent for the pixantrone/Rituxan recipients compared to zero percent for the Rituxan patients for both measurement intervals (p <0.001 and 0.003, respectively). The study also met its secondary endpoint demonstrating a significant improvement in major objective responses (>/= 50 percent shrinkage in tumor size). Seventy-five percent of patients treated with the pixantrone/Rituxan combination achieved a major response, with 35 percent achieving a complete response. This compares to 33 percent major response in patients who received Rituxan monotherapy, including 11 percent achieving a complete response (p = 0.02). Side effects on pixantrone were generally mild (grade 1 or 2) with the exception of severe (grade 4) treatment-related neutropenia, which was seen in two patients. The median cumulative dose of pixantrone administered was 1014 mg/m2; no cases of treatment-related grade 3 or 4 cardiac toxicity were reported