At a presentation at the CIBC World Markets 16th Annual Healthcare Conference in New York City, Cell Therapeutics 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.
The multicenter, randomized trial, also known as PIX302, compared the addition of pixantrone to standard Rituxan therapy to Rituxan therapy alone. The trial enrolled a total of 728 patients in order to detect a 30 percent improvement in time to disease progression (TTP) between treatment arms, the primary endpoint of the study. Overall response rate was a secondary endpoint of the trial.
The study achieved its primary objective of prolonging the time before a patient's lymphoma progressed 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. 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. No cases of treatment-related Grade 3 or 4 cardiac toxicity were reported.