Phase III trials of Rolontis show consistent efficacy and safety in neutropenia.

Spectrum Pharmaceuticals announced integrated analysis results from two Phase III clinical trials of Rolontis (eflapegrastim) a long-acting granulocyte colony-stimulating factor (G-CSF) being studied as a treatment for neutropenia in patients undergoing myelosuppressive cytotoxic chemotherapy. The analysis found that integrated efficacy and safety data from the two identically designed Phase III trials – ADVANCE and RECOVER – were consistent with results from the individual trials, demonstrating that Rolontis was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia (DSN) in all four cycles of treatment.

Integrated data derived from the two Phase III clinical trials, demonstrated that in Cycle 1, the mean DSN±SD was 0.24±0.581 days for Rolontis (n=314) and 0.36±0.789 days for pegfilgrastim (n=329), demonstrating non-inferiority (p<0.0001). The non-inferiority of Rolontis for DSN was maintained across all four treatment cycles (all p<0.0001). The Rolontis arm had an absolute risk reduction of severe neutropenia of 6.5% (95% CI: 0.2%, 13%) versus pegfilgrastim in Cycle 1. Absolute risk reduction was defined as the difference in the percentage of patients who experienced severe neutropenia (Rolontis 17.5%; pegfilgrastim 24%). Febrile neutropenia (3.2% vs. 3%; p=NS) and neutropenic complications (5.7% vs. 5.8%; p=NS) were similar between the Rolontis and pegfilgrastim arms.

Integrated safety data presented also showed that the adverse events in general, regardless of causality, were not significantly different between the two treatment arms. Spectrum Pharmaceuticals is currently working on a revised Biologics License Application (BLA) to submit to the FDA. The summary was presented during a poster session at the American Society of Clinical Oncology 2019 Annual Meeting in Chicago.