Phase III ADVANCE study of long acting Rolontis shows non inferiority to pegfilgrastim in treatment of neutropenia.- Spectrum Pharmaceuticals.
Spectrum Pharmaceuticals, Inc. announced detailed results from ADVANCE, a Phase III trial of Rolontis demonstrating that it was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia (DSN) in all four cycles of the study. Rolontis is a novel long-acting granulocyte colony-stimulating factor (G-CSF) being studied as a treatment for neutropenia in patients undergoing myelosuppressive cytotoxic chemotherapy. The data released online in an abstract as part of the American Society of Clinical Oncology 2018 Annual Meeting, also showed similar safety profiles between the treatment groups.
In the Rolontis Phase III ADVANCE study (n=406), mean DSN±SD was 0.19±0.478 days for Rolontis and 0.34±0.668 days for pegfilgrastim, demonstrating non-inferiority with 95 percent confidence interval (CI) of ?DSN: [-0.260, -0.035]; p<0.0001) in Cycle 1. The non-inferiority of Rolontis for DSN was maintained across all four treatment cycles. There were no statistically significant differences in all secondary endpoints including time to absolute neutrophil count (ANC) recovery, depth of ANC nadir and incidence of febrile neutropenia in Cycle 1. The most common adverse events, which were observed in less than 10 percent of patients, were similar across both treatment groups and were mainly hematologic, including neutropenia, lymphopenia, anemia and leukopenia.
Spectrum is currently conducting a second Phase III ROLONTIS trial, RECOVER, a multi-center study being conducted in the USA, Europe and Asia. The study is fully enrolled and expected to complete later this year. The company plans to conduct a pre-BLA meeting with the FDA in preparation for a planned BLA filing in the fourth quarter of 2018.
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