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news.Cell Therapeutics has presented data on its PIX301 trial of Pixuvri (pixantrone dimaleate), the first randomised controlled trial in patients with relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL), at lymphoma expert panel during the 15th Congress of the European Hematology Association.
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Cell Therapeutics’ PIX301 trial analyses demonstrated that patients who achieved a complete response (CR)/unconfirmed complete response (CRu) to Pixuvri had up to a 63% probability of being alive at 24 months compared to a 20% probability for patients treated with comparator agents.
The study showed a 21% improvement in overall survival for all patients who received Pixuvri that was independent of factors known to influence survival like prior rituximab use, international prognostic index (IPI) score, prior stem cell transplant, baseline level of LDH (lactate dehydrogenase), or refractory status based on univariate Cox regression analyses of survival.
Andreas Engert, professor at the University of Cologne in Germany, said: “The increases observed in clinically-important parameters like overall response rates (ORR) and progression free survival (PFS), provides important support to the clinical benefit of Pixuvri compared to current single-agent treatment in a setting where there are no approved or consensus therapies for relapsed or refractory aggressive NHL.
“I look forward to working with Cell Therapeutics as it prepares for submission of its marketing authorisation application (MAA) for Pixuvri to the European Medicines Agency (EMEA).”