Spectrum Pharmaceuticals Presents ADVANCE Phase 3 ROLONTIS (eflapegrastim) Data

Spectrum Pharmaceuticals (Nasdaq:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced detailed data from the ADVANCE Phase 3 study which showed that ROLONTIS had an absolute risk reduction of severe neutropenia of 8.5 percent (95% CI: 0.2%, 16.2%) versus pegfilgrastim in Cycle 1.

As quoted in the press release:

Absolute risk reduction was defined as the difference in percentage of the patients experiencing no severe neutropenia (ROLONTIS 84.2 percent; pegfilgrastim 75.7 percent). New safety data presented today also showed that the adverse events were not significantly different between two treatment arms. Data were presented today during an oral session at the Multinational Association of Supportive Care in Cancer (MASCC) 2018 Annual Meeting in Vienna, Austria. Earlier this year, the company revealed ADVANCE study data which demonstrated that ROLONTIS was non-inferior to pegfilgrastim in achieving the endpoint of the duration of severe neutropenia (DSN) across all 4 cycles (all p<0.0001). ROLONTIS is a novel, long acting granulocyte colony-stimulating factor (G-CSF) that utilizes a proprietary technology to treat chemotherapy-induced neutropenia.

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