Spectrum completes enrollment in Phase III trial of Rolontis for chemotherapy-induced neutropenia

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) completed enrollment of 405 patients in the Phase III ADVANCE trial of Rolontis eflapegrastim to treat chemotherapy-induced neutropenia. The open-label, North American trial is evaluating subcutaneous Rolontis on day 2 of each 21-day cycle vs. Neulasta pegfilgrastim for 4 cycles in early stage breast cancer patients receiving chemotherapy with docetaxel and cyclophosphamide.

The trial’s primary endpoint is the duration of severe neutropenia defined as absolute neutrophil counts of <5x10⁸/L in cycle 1. Secondary endpoints include time to absolute neutrophil count recovery, depth of absolute neutrophil count nadir and febrile neutropenia incidence in cycle 1...