Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) announced on 6/29/2018 detailed data from the ADVANCE Phase 3 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 today also showed that the adverse events were not significantly different between two treatment arms. Data were presented today 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.
Neutropenia is an abnormally low level of neutrophils. Neutrophils are a common type of white blood cell important to fighting off infections — particularly those caused by bacteria. Neutropenia is a common side effect of chemotherapy and can cause a disruption in treatment.
“Rolontis data presented today demonstrated that adverse events, including severe bone pain, were not statistically different from pegfilgrastim and occurred at rates that are expected for those undergoing chemotherapy,” said Lee Schwartzberg, M.D., FACP, lead investigator, professor of medicine and division chief, hematology oncology, University of Tennessee Health Science Center, and executive director, UT/West Cancer Center. “Furthermore, the absolute risk of severe neutropenia was lower for the ROLONTIS arm than pegfilgrastim. These new data help us better understand Rolontis as a potential new treatment option in supportive care for patients undergoing mylosuppressive chemotherapy.”
The company also announced that the RECOVER study, the second Phase 3 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).