Spectrum Pharmaceuticals Announces Results from the RECOVER Phase 3 Study of ROLONTIS® (eflapegrastim) at the 2018 SABCS Annual Meeting
- Primary endpoint of non-inferiority in the Duration of Severe Neutropenia (DSN) between ROLONTIS and pegfilgrastim was met
- No statistically significant differences in adverse event rates between treatment groups
- RECOVER is the second ROLONTIS Phase 3 study to meet the primary efficacy endpoint of non-inferiority in the DSN as compared to pegfilgrastim
- ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) that utilizes a proprietary platform technology to maximize the pharmacological activity of G-CSF, resulting in increased biological activity and a prolonged half-life
- ROLONTIS Biologics License Application (BLA) filing is expected by the end of the year
“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,
The data released yesterday in a poster presentation from the ROLONTIS Phase 3 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 ≥Grade 3 study drug related adverse events (AE) occurred in >2% of the patients and included hematologic and bone pain related AEs in both arms.
The RECOVER trial is the second ROLONTIS Phase 3 study to meet the
primary efficacy endpoint of non-inferiority in mean DSN. Results from
ADVANCE, the first ROLONTIS Phase 3 study, were announced at the 2018
“The RECOVER study is the second Phase 3 study to confirm
non-inferiority data and comparable safety profile between ROLONTIS and
the current standard of care,” said
The RECOVER study is a Phase 3, randomized, open-label, active-controlled, multicenter study that enrolled 237 breast cancer patients who received docetaxel and cyclophosphamide chemotherapy every 21 days. Patients were randomized in a 1:1 ratio to receive either ROLONTIS (n=118) or pegfilgrastim (n=119). The primary study endpoint was the DSN in Cycle 1 of chemotherapy (absolute neutrophil count [ANC] <0.5×109/L), based on central laboratory assessment of ANC over a 21 day cycle. There were a total of four cycles evaluated in this study. Secondary endpoints included, the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia at cycle one. Patients with stage I to stage IIIA breast cancer were treated on day one of each of the four cycles with adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On day two of each cycle, patients received a single subcutaneous dose of either eflapegrastim 13.2 mg/0.6 mL (equivalent to 3.6 mg G-CSF) or pegfilgrastim (6 mg).
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in hematology and oncology. Spectrum currently markets seven hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the company. Spectrum's strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
View source version on businesswire.com: https://www.businesswire.com/news/home/20181206005193/en/
Vice President, Strategic Planning & Investor Relations