Data from ADVANCE Phase III study of Rolontis shows non-inferiority to pegfilgrastim for management of severe neutropenia- - Spectrum Pharma.

Spectrum Pharmaceuticals, Inc. has announced detailed data from the ADVANCE Phase III study which showed that Rolontis had an absolute risk reduction of severe neutropenia of 8.5 percent (95% CI: 0.2%, 16.2%) versus pegfilgrastim in Cycle 1. Absolute risk reduction was defined as the difference in percentage of the patients experiencing no severe neutropenia (Rolontis 84.2 percent; pegfilgrastim 75.7 percent). New safety data presented also showed that the adverse events were not significantly different between two treatment arms. Data were presented during an oral session at the Multinational Association of Supportive Care in Cancer (MASCC) 2018 Annual Meeting in Vienna, Austria.

Earlier this year, the company revealed ADVANCE study data which demonstrated that Rolontis was non-inferior to pegfilgrastim in achieving the endpoint of the duration of severe neutropenia (DSN) across all 4 cycles (all p<0.0001). rolontis is a novel, long acting granulocyte colony-stimulating factor (g-csf) that utilizes a proprietary technology to treat chemotherapy-induced neutropenia. the company also announced that the recover study, the second phase iii rolontis study, met the primary efficacy endpoint of non-inferiority in dsn between rolontis and pegfilgrastim. the adverse event profile was also similar between the two treatment arms. the recover study evaluated the safety and efficacy of rolontis in the management of chemotherapy-induced neutropenia in patients with early-stage breast cancer (n="237).">

The company previously announced in February 2018 that the ADVANCE study, the first Phase III Rolontis study, met the primary efficacy endpoint of non-inferiority in DSN between Rolontis and pegfilgrastim. 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 difference in DSN: [-0.260, -0.035]; p<0.0001) in cycle 1. the advance study also demonstrated a similar adverse event profile between treatment arms.>

Comment: Rolontis was non-inferior to pegfilgrastim in terms of the duration of severe neutropenia across four cycles of chemo treatment. The drug also was associated with a lower rate of severe neutropenia compared with pegfilgrastim (84.2% versus 75.7%).

Comment: Rolontis is being positioned to take on the market of Amgen Inc.'s blockbuster Neulasta (pegfligrastim) for the prevention of neutropenia in patients undergoing chemotherapy. Neulasta has been the only long-acting GSF on the market, but biosimilars are on the way. The FDA approved Mylan NV/Biocon Ltd.'s pegfilgrastim biosimilar Fulphila (pegfilgrastim-jmdb) in June 2018.