Policy & Regulation
Phase 3 Trial of Pixuvri Combination for Aggressive Lymphoma Fails to Meet Primary Endpoint
12 July 2018 - - Seattle,Washington-based blood-related cancers therapies specialist CTI BioPharma Corp. (NASDAQ/MTA: CTIC) and Suresnes, France-based international pharmaceutical company Servier have released results indicating that the phase III trial (PIX306) evaluating Pixuvri (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma did not meet its primary endpoint of an improvement in progression-free survival, the companies said.
The PIX306 trial is a randomized, multicenter trial comparing pixantrone combined with rituximab versus gemcitabine combined with rituximab in 312 patients with aggressive B-cell non-Hodgkin lymphoma who had relapsed after therapy with CHOP-R or an equivalent regimen and were ineligible for stem cell transplant.
The primary endpoint was progression-free survival while overall survival, complete response rate, overall response rate, and safety were secondary endpoints.
Pixantrone is a cytotoxic medicine that interferes with DNA replication causing cancer cells to stop dividing and eventually die.
Servier, governed by a non-profit foundation, has an international presence in 148 countries and employs 21,000 people worldwide.
Entirely independent, the group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development in five areas: cardiovascular, immune-inflammatory, neuropsychiatric, cancers, and diabetes.
CTI BioPharma is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers. The company has a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis.
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