Rolvedon Same-Day Dosing Shows Promise for Breast Cancer Patients in Phase 1 Trial
核心洞察
Assertio's phase 1 trial demonstrated that same-day dosing of Rolvedon (eflapegrastim-xnst (搜索)) with TC chemotherapy achieved similar efficacy and safety to next-day dosing in early-stage breast cancer patients.
The study enrolled 53 patients across 13 U.S. sites, showing a mean neutrophil recovery time of 1.8 days and only one case of febrile neutropenia throughout the trial.
Results published in The Oncologist suggest this more convenient dosing schedule could improve patient care, though randomized controlled trials are still needed to confirm benefits.
Assertio Holdings (搜索) has announced the publication of positive results from a phase 1 clinical trial investigating same-day dosing of Rolvedon (eflapegrastim-xnst (搜索)) in patients with early-stage breast cancer, offering potential for more convenient treatment administration.
The study, published in The Oncologist, evaluated whether administering Rolvedon on the same day as TC chemotherapy (docetaxel and cyclophosphamide) could maintain the efficacy and safety profile seen with traditional next-day dosing. Results demonstrated that same-day administration achieved effective neutrophil recovery with a similar adverse event profile.
Trial Design and Patient Population
The multicenter, open-label phase 1 trial (NCT04187898) enrolled 53 patients with early-stage breast cancer across 13 sites in the United States. Patients received four cycles of TC chemotherapy with Rolvedon administered 30 minutes after chemotherapy completion. Of the enrolled patients, 49 completed the study.
The primary endpoint focused on time to recovery of absolute neutrophil count (ANC) from nadir to ≥1.5 × 10⁹/L in cycle 1. Secondary endpoints included safety measures, incidence of severe neutropenia, duration of severe neutropenia, incidence of febrile neutropenia, and neutropenic complications.
Clinical Outcomes and Safety Profile
Patients received the recommended 13.2 mg (3.6 mg GCSF) fixed-dose of Rolvedon 30 minutes following TC chemotherapy. The mean time to ANC recovery was 1.8 days in cycle 1, indicating effective neutrophil restoration.
Safety results were particularly encouraging, with the incidence of febrile neutropenia reported in only one patient during the entire trial. No neutropenic complications occurred, and no patients required hospitalization or antibiotic therapy related to neutropenia. Same-day administration was well tolerated with no new safety signals observed.
Clinical Significance and Expert Perspectives
"We were encouraged to see that same-day dosing of Rolvedon demonstrated efficacy and safety similar to dosing one day after chemotherapy," said Howard Franklin, M.D., Senior Vice President of Medical with Assertio. "Assertio is proud to lead this study that provides data that supports a more convenient administration schedule for Rolvedon."
Lee Schwartzberg, M.D., Professor of Clinical Medicine with Renown Health-Pennington Cancer Institute and study author, emphasized the clinical relevance: "Febrile neutropenia (FN) is a significant risk factor among patients with early-stage breast cancer who are undergoing chemotherapy. This important study provides the oncology community with much-needed insight into the potential utility of same-day dosing of GCSF therapy with Rolvedon in these patients."
Study Limitations and Future Directions
The researchers noted that the benefits of eflapegrastim-xnst (搜索) given same day as TC chemotherapy have not been evaluated in a randomized controlled trial. This represents an important limitation that may need to be addressed in future studies to establish definitive clinical benefits.
About Rolvedon
Rolvedon (eflapegrastim-xnst (搜索)) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. The drug is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
The study results were first presented in December 2024 at the San Antonio Breast Cancer Symposium before publication in The Oncologist, the official peer-reviewed medical journal for the Society for Translational Oncology.