Spectrum's Rolontis meets in Phase III for chemotherapy-induced neutropenia
Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) reported top-line data from the Phase III ADVANCE trial in 406 patients with early stage breast cancer who received docetaxel and cyclophosphamide every 21 days showing that Rolontis eflapegrastim (LAPS-GCSF, HM10460A, SPI-2012) met the primary endpoint of non-inferiority to Neulasta pegfilgrastim in the duration of severe neutropenia defined as an absolute neutrophil count of <0.5x109/L in cycle one of chemotherapy.
The open-label, U.S. trial is evaluating subcutaneous Rolontis on day two of each 21-day cycle vs. Neulasta for four cycles. Secondary endpoints in the trial include time to absolute neutrophil count recovery, depth of absolute neutrophil count nadir and febrile neutropenia incidence in cycle one. Spectrum has an SPA from FDA for the trial...