Spectrum Pharmaceuticals announced that data from the Phase 3 RECOVER clinical study was presented during the 2018 San Antonio Breast Cancer Symposium. These data confirm the efficacy and safety of ROLONTIS in reducing the Duration of Severe Neutropenia in breast cancer patients treated with chemotherapy. ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor being studied as a treatment for neutropenia in patients undergoing treatment with myelosuppressive cytotoxic chemotherapy. The data released yesterday in a poster presentation from the ROLONTIS Phase 3 RECOVER study showed that in Cycle 1, the mean DSN+/-SD was 0.31+/-0.688 days for ROLONTIS and 0.39+/-0.949 days for pegfilgrastim, demonstrating non-inferiority. The non-inferiority of ROLONTIS for DSN was maintained across all four treatment cycles. Incidence of severe neutropenia was 20 percent versus 24 percent in the eflapegrastim and pegfilgrastim arms respectively, with a relative risk reduction of 14 percent in favor of eflapegrastim. There were no statistically significant differences on secondary endpoints such as time to absolute neutrophil count recovery, depth of ANC nadir, and incidence of febrile neutropenia between treatment arms across all cycles. None of the greater than or equal to Grade 3 study drug related adverse events occurred in greater than 2% of the patients and included hematologic and bone pain related AEs in both arms. The RECOVER trial is the second ROLONTIS Phase 3 study to meet the primary efficacy endpoint of non-inferiority in mean DSN. Results from ADVANCE, the first ROLONTIS Phase 3 study, were announced at the 2018 American Society of Clinical Oncology Annual Meeting and presented at the Multinational Association in Supportive Care in Cancer Annual Meeting earlier this year.
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