Successful Phase III RECOVER study of Rolontis to treat neutropenia associated with chemotherapy in breast cancer patients . Spectrum Pharma.

Spectrum Pharmaceuticals, Inc. announced that data from the Phase III RECOVER clinical study was presented during the 2018 San Antonio Breast Cancer Symposium (SABCS). These data confirm the efficacy and safety of Rolontis (eflapegrastim) in reducing the Duration of Severe Neutropenia (DSN) in breast cancer patients treated with chemotherapy. Rolontis is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) being studied as a treatment for neutropenia in patients undergoing treatment with myelosuppressive cytotoxic chemotherapy.

�Despite available treatments, neutropenia remains a critical issue for patients undergoing chemotherapy that puts them at risk for developing life threatening infections,� said Lee Schwartzberg, MD, FACP, lead investigator, professor of medicine and division chief, hematology/oncology, University of Tennessee Health Science Center, and executive director, UT/West Cancer Center. �The robust data from both Phase III studies demonstrate that Rolontis has the potential to be a valuable option in the management of neutropenia for patients undergoing treatment with chemotherapeutic agents.�

The data released in a poster presentation from the Rolontis Phase III RECOVER study (n=237) 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 (p<0.0001). the non-inferiority of rolontis for dsn was maintained across all four treatment cycles (all (p><0.0001)). 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 (anc) recovery, depth of anc nadir, and incidence of febrile neutropenia between treatment arms across all cycles. none of the greater then grade 3 study drug related adverse events (ae) occurred in more than 2% of the patients and included hematologic and bone pain related aes in both arms. the recover trial is the second rolontis phase iii study to meet the primary efficacy endpoint of non-inferiority in mean dsn.>

Results from ADVANCE, the first Rolontis Phase III study, were announced at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting and presented at the Multinational Association in Supportive Care in Cancer Annual Meeting (MASCC) earlier this year.