ROLVEDON™ was studied in 2 Phase III clinical trials (n=643)1-3
- Study 1 (n=406) and study 2 (n=237) were identically designed Phase III randomized, open-label, noninferiority trials of eflapegrastim vs pegfilgrastim to prevent chemotherapy-induced neutropenia (CIN)1-3
- Studied in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) intravenously every 21 days for 4 cycles1-3
- A fixed dose of eflapegrastim (13.2 mg/0.6 mL) or pegfilgrastim (6 mg/0.6 mL) was administered on day 2 of each cycle after TC chemotherapy1-3
- Primary Endpoint: Duration of severe neutropenia (DSN) in cycle 11-3
- Key Secondary Endpoints: Time to ANC recovery in cycle 1, depth of ANC nadir in cycle 1, incidence of FN in cycle 11,3
- Additional Secondary Endpoints: DSN in cycles 2, 3, and 4; incidence of neutropenic complications† during cycle 1; incidence of FN in cycles 2, 3, and 4; RDI of TC chemotherapy in cycles 1 to 4, safety1,3
ANC=absolute neutrophil count; DSN=duration of severe neutropenia; FN=febrile neutropenia; RDI=relative dose intensity; TC=docetaxel and cyclophosphamide.
*Standard dose TC.
†Neutropenic complications were defined as anti-infective use or hospitalizations.
- Schwartzberg LS, Bhat G, Peguero J, et al. Eflapegrastim, a long-acting granulocyte-colony stimulating factor for the management of chemotherapy-induced neutropenia: results of a phase III trial. Oncologist. 2020; 25(8):e1233-e1241.
- ROLVEDON [package insert]. Irvine, CA: Spectrum Pharmaceuticals, Inc.
- Cobb PW, Moon YW, Mezei K, et al. A comparison of eflapegrastim to pegfilgrastim in the management of chemotherapy-induced neutropenia in patients with early-stage breast cancer undergoing cytotoxic chemotherapy (RECOVER): a phase 3 study. Cancer Med. 2020;9(17):6234-6243.
Proven to reduce duration of severe neutropenia
ROLVEDON has a proven safety profile